june 2017 page 38 - cap today

automated immunoassay analyzers

Tabulation does not represent an endorsement by the College of American Pathologists.

38 CAP TODAY | JUNE 2017

JUNE 2017 page 38

Part 1 of 21 Abbott Diagnostics Abbott Diagnostics Abbott Diagnostics100 Abbott Park Rd., CP1-4 100 Abbott Park Rd., CP1-4 100 Abbott Park Rd., CP1-4

See captodayonline.com/productguides for an interactive version of guide

Abbott Park, IL 60064 Abbott Park, IL 60064 Abbott Park, IL 60064224-667-5678 www.abbottdiagnostics.com 224-667-5678 www.abbottdiagnostics.com 224-667-5678 www.abbottdiagnostics.com

Name of instrument/First year sold/Where designed ARCHITECT i1000SR/2008/U.S. ARCHITECT i2000SR/2002, i4000SR/2007/U.S. ARCHITECT ci4100 (2009), ci8200 (2003), ci16200 (2007)/U.S.

Country where manufactured/Where reagents manufactured Singapore/U.S., Europe Singapore/U.S., Europe Singapore (IA), Japan (chemistry)/U.S., EuropeNumber of units in clinical use in U.S./Outside U.S. — — —Operational type/Model type/Sample handling system continuous random access/floor standing/robotic sample

handler allows batch, random access, continuous access, and reagent loading and unloading

batch, random access, continuous random access/ floor standing/track and LAS

batch, random access, continuous random access/floor standing/robotic sample handler uses multidimensional sample handling

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 49 × 59 × 30/12.3 48 × 61 × 49/20.7 (i2000SR) 48 × 127 × 49/43.2

Tests available on instrument in U.S. — — —Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — — —Tests in development — — —Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system — — —Number of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —

Methods supported/Separation methods chemiluminescence/magnetic particle Chemiflex (enhanced chemiluminescence) with 5 flexible protocols/magnetic microparticle

photometric, potentiometric, and Chemiflex (enhanced chemiluminescence)/—

Number of different measured assays onboard simultaneously 25 25 80–93, based on analyzerNumber of different assays programmed, calibrated at once 61 62 149 assays availableNumber of user-definable (open) channels none none 220 (on chemistry modules only)Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

25/100 25/100 tests and 500 tests per kit 93/61–1,700

Shortest/Median onboard reagent stability/Refrigerated onboard 14 days (vitamin D)/30 days tracked in hours/yes 14 days (vitamin D)/30 days tracked in hours/yes CC: 5 days/28 days/yes; IA: 14 days (vitamin D)/30 days tracked in hours/yes

Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/assay number, reagent serial number, lot number, tests

per kit, expiration, onboard stability time, othersyes/assay No., reagent serial No., lot No., tests per kit, exp. date, onboard stability time, master calibration curve

yes/assay name, reagent number, lot number, tests per kit, expiration date, others

Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/<0.1 ppm no/<0.1 ppm yes (chemistry)/<0.1 ppmWalkaway capacity in minutes/Specimens/Tests, assays 180/65/25 300/135/12,500 300/367/>75,000System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid yes (chemistry)/liquidUses disposable cuvettes/Maximum number stored yes/360 yes/1,200 disposable and semipermanent/see individual standalone

modulesUses washable cuvettes/Replacement frequency no/— no/— yes/as needed, minimum 1-year guaranteeMinimum specimen volume required varies based on assay varies based on assay varies based on assayMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/50 µL 10 µL/50 µL 2 µL (chemistry), 10 µL (IA)/50 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/yesRequires dedicated water system/Water consumption no/— no/— yes/25 L per hour (ci8200); 52 L per hour (ci16200);

15 L per hour (ci4100)Noise generated 58 decibels during normal operation, 62 decibels maximum 48–70 decibels 48 –70 decibelsHas dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/5-, 7-,10-mL tubes and sample cups/no yes/5-, 7-,10-mL tubes and sample cups/no yes/5-, 7-, 10-mL tubes and sample cups/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no yes/yesDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 2–6, assay dependent 2–6, assay dependent 2–6, assay dependentCalibrants can be stored onboard/Average calibration frequency no/calibration required with new lot no/calibration required with new lot IA: no/calibration with new lot; CC: no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes (up to 4 curves per analyte) yes/yes (up to 4 curves per analyte) yes/yes (up to 4 curves per analyte)How often QC required every 24 hours or per lab-specific procedure every 24 hours or per lab-specific procedure every 24 hours or per lab-specific procedureOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/6.5 minutes —/no/10 minutes —/no/10 minutes

Stat time to completion of βhCG test 18 minutes 18 minutes 18 minutes

Time delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

up to 33 samples/100 tests per hour up to 67 samples/200 tests per hour up to 267/800 (c4000); 400/1200 (c8000); 600/1800 (c16000); 33/100 (i1000SR); 67/200 (i2000SR)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yes

Data-management capability/Instrument vendor supplies LIS interface onboard/no onboard/no onboard/no

LIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes yes noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator yes yes, AbbottLink yes, AbbottLink

On-site response time of service engineer — — —Mean time between failures/To repair failures — — —

Average time to complete maintenance by lab personnel — — —

Onboard maintenance records/Maintenance training demo module yes/yes yes/yes yes/yes

List price/Targeted bed size or daily volume — — —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/yes yes/yes yes/yes

Distinguishing features (supplied by company)

Note: a dash in lieu of an answer means company did not answer question or question is not applicable

streamlined workload management; continuous access to reagents, samples, and supplies; 65-sample load capacity; 13 universal bays, 7 customizable priority bays; refrigerated reagent carousel with 25 × 100 test-kit sizes; reagents stable onboard up to 30 days; priority tests; 18-minute turnaround time on stat assays

Chemiflex technology delivers excellent sensitivities and extended linearities; RSH allows priority and routine samples to be processed simultaneously without compromising stats; refer to operations manual for operational precautions, limitations, and hazards; class 1 laser product

integration of CC and IA without compromising stat turnaround time, results, or throughput because of patented SmartWash technology, which minimizes carryover to <0.1 ppm; reagent capacity of 93 assays, with sample load up to 367; refer to operations manual for operational precautions, limitations, and hazards


JUNE 2017 | CAP TODAY 39


JUNE 2017 page 39

Part 2 of 21 Alere Alere AlereBeata Blyskal [email protected] Beata Blyskal [email protected] Beata Blyskal [email protected]


2 Research Way, Princeton, NJ 08540 2 Research Way, Princeton, NJ 08540 2 Research Way, Princeton, NJ 08540609-627-8042 www.alere.com 609-627-8042 www.alere.com 609-627-8042 www.alere.com

Name of instrument/First year sold/Where designed Agility/2012/U.S. DS2/2007/U.S. DSX/2004/U.S.Country where manufactured/Where reagents manufactured U.S./worldwide U.S./worldwide U.S./worldwideNumber of units in clinical use in U.S./Outside U.S. 50/50 800/1,500 1,200/1,800Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/rack batch/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 49 × 50 × 36/8.6 26 × 21 × 27/3.79 32 × 42 × 36/7

Tests available on instrument in U.S. open system, tests provided by various manufacturers open system, tests provided by various manufacturers open system, tests provided by various manufacturersTests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — — —Tests in development — — —Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system yes yes yesNumber of each analyte performed in separate disposable unit 1 per well 1 per well 1 per wellNumber of wells in microplate 96 (minimum: 1 strip; maximum: 12 full plates) 96 (minimum: 1; maximum: 96) 96 (minimum: 1; maximum: 96)

Methods supported/Separation methods enzyme immunoassay/coated microplate wells enzyme immunoassay/coated microwell enzyme immunoassay/coated microwellNumber of different measured assays onboard simultaneously 16 assay dependent (24 control positions) assay dependent (33 control positions)Number of different assays programmed, calibrated at once 12 assay dependent (24 control positions) assay dependent (33 control positions)Number of user-definable (open) channels unlimited unlimited unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

16/96 assay dependent (18 reagent positions)/96 assay dependent (24 reagent positions)/96

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no —/—/no —/—/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes, 2 mL control vials (other reagents are pour off) yes, 2 mL control vials (other reagents are pour off)Reagents barcoded/Information in barcode yes/lot information no/— no/—

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/none, uses disposable tips yes/none, uses disposable tips yes/none, uses disposable tipsWalkaway capacity in minutes/Specimens/Tests, assays assay dependent/200+ continuous load/12+ continuous load assay dependent/100/assay dependent assay dependent/98/assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid yes/liquid

Uses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—

Minimum specimen volume required 10 µL 10 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/150 µL 10 µL/50 µL 5 µL/50 µL

Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—

Noise generated — — —

Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–17 mm diameter, 45–100 mm depth/no yes/10–16 mm diameter, 40–100 mm depth/no yes/10–16 mm diameter, 40–100 mm depth/no

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A — — —Onboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes no/yes no/yesAutomatic detection of adequate reagent or specimen yes yes yes

Clot detection/Reflex testing capability yes/no yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — — —

Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/per plate no/within each run no/within each runMultipoint calib. supported/Multiple calibs. stored for same assay no/no no/no no/no

How often QC required per plate with every assay with every assayOnboard real-time QC/Support multiple QC lot Nos. per analyte no/no no/yes no/yes

Automatic shutdown/Startup is programmable/Startup time yes/yes/15 minutes yes/yes/5 minutes yes/yes/5 minutes

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/— assay dependent/— assay dependent/—

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/yes (additional cost) onboard/yes (additional cost)LIS interfaces up and running in active user sites yes (Cerner, Sunquest, Soft, Orchard, etc.) yes (Cerner, Sunquest, Soft, Orchard, etc.) yes (Cerner, Sunquest, Soft, Orchard, etc.)LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (host query) yes (host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes no/yes/yes no/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours (contract dependent) 24 hours (contract dependent) 24 hours (contract dependent)Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: <15 minutes; weekly: <30 minutes; monthly: <1 hour daily: 5 minutes; weekly: 20 minutes; monthly: 20 minutes daily: 10 minutes; weekly: 20 minutes; monthly: 20 minutesOnboard maintenance records/Maintenance training demo module no/no no/no no/no

List price/Targeted bed size or daily volume —/various —/various —/variousAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/— yes/— yes/—



SmartKit, direct-load reagents can be loaded at any time, in any order, thus reducing preanalytic time by more than 60% of traditional ELISA automation systems; the 2-D barcode on each SmartKit is detected, loaded, and tracked in real time, continuously; open platform capacity allows for a very flexible test menu to automate Alere’s ~100 ELISA assays along with any other ELISA manufacturer and eliminates carryover possibility with disposable tips

combined with the Alere ELISA product line and the ability to automate enteric assays and front-end dilute Athena Multi-Lyte assays, the DS2 provides an efficient, open, fully automated solution for customers looking for laboratory automation

open DSX platform enables customers to run many ELISA-based assays; modular design allows users to customize system to unique needs; work list load wizard for easy setup; shows graphically where to place reagents, samples, and plates at beginning of each run; complete daily maintenance in less than 5 minutes, including removal of consumables and rinsing washer


JUNE 2017 page 40



Part 3 of 21 Arlington Scientific Awareness Technology Awareness TechnologyMike LaDow [email protected] Jamie Ristaino [email protected] Jamie Ristaino [email protected]


1840 N. Technology Drive, Springville, UT 84663 1935 SW Martin Highway, Palm City, FL 34990 1935 SW Martin Highway, Palm City, FL 34990801-489-8911 www.arlingtonscientific.com 772-283-6540 www.awaretech.com 772-283-6540 www.awaretech.com

Name of instrument/First year sold/Where designed ASI Infinity/1998/U.S. ChemWell Fusion/2014/U.S. ChemWell 2910/1998/U.S.

Country where manufactured/Where reagents manufactured U.S./U.S. U.S./— U.S./—

Number of units in clinical use in U.S./Outside U.S. 80/4,350 0/10+ 80+/4,350+

Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/rack batch/benchtop/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 19 × 36 × 24/6 16 × 34 × 20/4 16 × 34 × 20/4

Tests available on instrument in U.S. unlimited (open system) unlimited (open system) unlimited (open system)

Tests not available in U.S. but submitted for clearance — — —

Tests not available in U.S. but available in other countries unlimited (open system) unlimited (open system) unlimited (open system)

Tests in development — — —

Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system yes yes yesNumber of each analyte performed in separate disposable unit 12 up to 12 up to 12Number of wells in microplate minimum strip: 8; maximum full plate: 96 minimum strip: 8; maximum full plate: 96 minimum strip: 8; maximum full plate: 96

Methods supported/Separation methods enzyme immunoassay/coated microwell enzyme immunoassay (ELISA) and CLIA/coated microwell plate, strips

enzyme immunoassay/coated microwell

Number of different measured assays onboard simultaneously 12 up to 12 up to 12Number of different assays programmed, calibrated at once unlimited unlimited unlimitedNumber of user-definable (open) channels unlimited unlimited unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

27/assay dependent 27/assay dependent 27/assay dependent

Shortest/Median onboard reagent stability/Refrigerated onboard assay dependent/assay dependent/no assay dependent/assay dependent/yes (10°C below ambient) assay dependent/assay dependent/yes (10°C below ambient)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode no/— no/— no/—Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero no/zero no/zeroWalkaway capacity in minutes/Specimens/Tests, assays assay dependent/96/12 assay dependent/96/12 assay dependent/96/12System is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid yes/liquidUses disposable cuvettes/Maximum number stored yes/96 yes/96 yes/96Uses washable cuvettes/Replacement frequency yes/assay dependent yes/assay dependent yes/assay dependentMinimum specimen volume required 2 µL 2 µL 2 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 2 µL/— 2 µL/— 2 µL/—Supplied with UPS (backup power)/Requires floor drain no/no no/no no/noRequires dedicated water system/Water consumption no/30 mL no/— no/—Noise generated 15 decibels — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12 × 100 mm/no yes/12 × 100 mm/no yes/12 × 100 mm/noSample barcode reading capability/Autodiscrimination no/yes no/— no/—Barcode placement per CLSI standard Auto2A — — —Onboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection no/no no/no no/noAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability no/yes no/yes no/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/yes yes/yes yes/yes

Time between initial result and reaspiration of sample for rerun assay dependent assay dependent assay dependentAutocalibration or autocalibration alert no no noNumber of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency yes/assay dependent yes/assay dependent yes/assay dependentMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required shortest interval: each run; longest: daily shortest interval: each run; longest: daily shortest interval: each run; longest: dailyOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/2 minutes yes/yes/2 minutes yes/yes/2 minutes

Stat time to completion of βhCG test assay dependent assay dependent assay dependent

Time delay from ordering stat test to aspiration of sample 30 seconds 30 seconds 30 seconds Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/96 (2 hours) assay dependent/— assay dependent/—

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (included) onboard/yes (included) onboard/yes (included)LIS interfaces up and running in active user sites yes — —LIS interface operates simultaneously with running assays no no noBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer within 48 hours within 48 hours within 48 hoursMean time between failures/To repair failures 12 months/4 days — —Average time to complete maintenance by lab personnel daily: <10 minutes; weekly: <10 minutes;

monthly: <10 minutesdaily: <10 minutes; weekly: <10 minutes; monthly: <10 minutes

daily: <10 minutes; weekly: <10 minutes; monthly: <10 minutes

Onboard maintenance records/Maintenance training demo module no/— no/no no/no

List price/Targeted bed size or daily volume $25,000/20 and above $29,000/up to 500 tests per day $25,000/up to 500 tests per dayAnnual service contract cost (24 hours/7 days) $4,000 $4,500 $4,000

Training provided with purchase/Advanced operator training 2 days on site, 2 days at vendor offices/yes 3 days on site/no 3 days on site/no



low cost; small footprint; open system dual use as random-access ELISA and CLIA analyzer, capable of performing ELISA and CLIA on the same microwell plate using 8-well microwell strips

dual use as random-access biochemistry analyzer when not in EIA mode; optional reagent cooling module


JUNE 2017 page 41



Part 4 of 21 Beckman Coulter Beckman Coulter Beckman CoulterSharon Stieg [email protected] Sharon Stieg [email protected] Sharon Stieg [email protected]


250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com

Name of instrument/First year sold/Where designed Access 2 Immunoassay System/2001/U.S. UniCel DxI 600 Access Immunoassay System/2007/U.S. UniCel DxI 800 Access Immunoassay System/2003/U.S.Country where manufactured/Where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland U.S./U.S., France, IrelandNumber of units in clinical use in U.S./Outside U.S. — — —Operational type/Model type/Sample handling system continuous random access/benchtop/rack continuous random access/floor standing/rack, direct track

samplingcontinuous random access/floor standing/rack, direct track sampling

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 18.5 × 39 × 24/6.5 67 × 61.5 × 37.5/16.02 67 × 67.5 × 37.5/17.6

Tests available on instrument in U.S. cortisol, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultra-sensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, p2PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others

cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others


Tests not available in U.S. but submitted for clearance AMH AMH —Tests not available in U.S. but available in other countries HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg

confirmatory, CMV IgG, CMV IgM, rubella IgMHAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM

HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM

Tests in development — — AMHTests not available on other manufacturers’ analyzers — — —

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —

Methods supported/Separation methods chemiluminescence/magnetic particle chemiluminescence/magnetic particle chemiluminescence/magnetic particleNumber of different measured assays onboard simultaneously 24 50 50Number of different assays programmed, calibrated at once 24 50 50Number of user-definable (open) channels 0 — 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

24/100 tests per kit; 50 tests per cartridge 50/100 and 300 tests per kit; 50 tests per cartridge 50/100 and 300 tests per kit; 50 tests per cartridge

Shortest/Median onboard reagent stability/Refrigerated onboard 14 days/28 days/yes (3°–10°C) 14 days/28 days/yes (3°–10°C) 14 days/28 days/yes (3°–10°C)

Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/specific cartridge ID, expiration date, lot number, unique

reagent pack ID numberyes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration

yes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration

Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/<10 ppm yes/<10 ppm yes/<10 ppmWalkaway capacity in minutes/Specimens/Tests, assays up to 180 based on consumable capacity/60/assay dependent 180–240 based on consumable capacity/60/assay dependent 180–240 based on consumable capacity/120/

assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquid

Uses disposable cuvettes/Maximum number stored yes/294 yes/1,000 yes/>1,000Uses washable cuvettes/Replacement frequency no/— no/— no/—

Minimum specimen volume required specimen container dependent specimen container dependent specimen container dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/100 µL 5 µL/80 µL 5 µL/160 µLSupplied with UPS (backup power)/Requires floor drain no/no no/no no/noRequires dedicated water system/Water consumption no/— no/— no/—

Noise generated <70 decibels <65 decibels <60 decibels

Has dedicated pediatric sample cup/Dead volume yes/100 µL yes/100 µL yes/100 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12 × 75, 13 × 75 and 100, 16 × 75 and 100/no yes/12 × 75, 13 × 75 and 100, 16 × 75, 85, and 100 mm/no yes/12 × 75, 13 × 75 and 100, 16 × 75, 85, and 100 mm/no

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yes

Onboard test auto inventory (determines volume in container) no no noMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yes

Clot detection/Reflex testing capability yes/yes (Access 2 only) yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability no/no yes/yes yes/yes

Sample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun 36 seconds 36 seconds 36 secondsAutocalibration or autocalibration alert no yes yesNumber of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/28 days no/28 days no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours 24 hours 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yes

Automatic shutdown/Startup is programmable/Startup time no/no/remains in ready mode no/no/remains in ready mode no/no/remains in ready mode

Stat time to completion of βhCG test 15 minutes 15 minutes 15 minutesTime delay from ordering stat test to aspiration of sample ≥36 seconds 18 seconds 18 seconds Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

33/100 (36 seconds) —/200 (18 seconds) ≤133/≤400 (9–18 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes onboard/yes onboard/yesLIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no yes, Beckman Coulter automation systems yes, Beckman Coulter automation systemsModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no yes/yes/yes yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — — —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 15 minutes; weekly: 30 minutes daily: <10 minutes daily: <10 minutes

Onboard maintenance records/Maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/online help with maintenance instructions

List price/Targeted bed size or daily volume $149,800/all volumes and hospital sizes $199,500/200–300 beds or 100–300 tests per day $325,000/300+ beds or >400 tests per dayAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/yes yes/yes yes/yes



ability to network up to four Access 2 systems using one LIS interface with remote diagnostics; fully automated user-defined reflex testing; continuous random-access benchtop analyzer

uses chemiluminescent technology; allows operators to load consumables on the fly, without interacting with the system

high-throughput immunoassay analyzer; uses chemiluminescent technology; allows operators to load consumables on the fly, without interacting with the system; offers ProService remote diagnostic service capability




JUNE 2017 page 42

Part 5 of 21 Beckman Coulter Beckman Coulter Beckman CoulterSharon Stieg [email protected] Sharon Stieg [email protected] Sharon Stieg [email protected]


250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com

Name of instrument/First year sold/Where designed UniCel DxC 600i Synchron Access Clinical System/2006/U.S. UniCel DxC 660i Synchron Access Clinical System/2009/U.S. UniCel DxC 680i Synchron Access Clinical System/2009/U.S.Country where manufactured/Where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland U.S./U.S., France, IrelandNumber of units in clinical use in U.S./Outside U.S. — >40/>20 5/13Operational type/Model type/Sample handling system continuous random access/floor standing/rack-closed tube continuous random access/floor standing/

rack-closed tubecontinuous random access/floor standing/ rack-closed tube

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 62 × 128 × 48/42.7 68 × 147 × 48/49 68 × 153 × 48/51

Tests available on instrument in U.S. cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others

cortisol, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultra-sensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others



Tests not available in U.S. but available in other countries CMV IgG, CMV IgM, rubella IgM HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM

HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM

Tests in development AMH AMH AMHTests not available on other manufacturers’ analyzers — — —


Methods supported/Separation methods chemiluminescence, enzyme immunoassay/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particleNumber of different measured assays onboard simultaneously 89 115 115Number of different assays programmed, calibrated at once 89 115 115Number of user-definable (open) channels 100 100 100Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

89/100 tests per kit (immunoassay); 300 tests per container (general chemistry)



Shortest/Median onboard reagent stability/Refrigerated onboard 14 days/28 days/yes (3°–10°C) 14 days/28 days/yes (3°–10°C) 14 days/28 days/yes (2°–10°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/specific cartridge ID, number of available tests, expiration

date, lot number, calibration expiration, within lot calibrationyes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration

yes/specific cartridge ID, No. of available tests, expiration date, lot No., calibration expiration, within lot calibration

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/<10 ppm yes/<10 ppm yes/<10 ppmWalkaway capacity in minutes/Specimens/Tests, assays 60/76/assay dependent 60/76/assay dependent 60/76/assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquid

Uses disposable cuvettes/Maximum number stored yes/125 yes/125 yes/125Uses washable cuvettes/Replacement frequency yes/— yes/— yes/—Minimum specimen volume required container dependent container dependent container dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 3 µL/20 µL (general chemistry) 3 µL/80 µL 3 µL/80 µLSupplied with UPS (backup power)/Requires floor drain yes/yes yes/yes yes/yesRequires dedicated water system/Water consumption yes/16 L per hour yes/up to 16 L per hour yes/up to 16 L per hour

Noise generated — — —

Has dedicated pediatric sample cup/Dead volume yes/— yes/— yes/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes yes/13 × 75 and 100, 15 × 92 and 75, 16 × 100 mm/yes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yes

Onboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes (general chemistry) yes/yes (general chemistry) yes/yes (general chemistry)Dilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/yes yes/yes yes/yes

Time between initial result and reaspiration of sample for rerun chemistry dependent chemistry dependent chemistry dependentAutocalibration or autocalibration alert — — —Number of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/28 days no/28 days no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yes

How often QC required 24 hours 24 hours 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/remains in ready mode no/no/remains in ready mode no/no/remains in ready mode

Stat time to completion of βhCG test 15 minutes 15 minutes 15 minutesTime delay from ordering stat test to aspiration of sample 1 minute (general chemistry) 1 minute (general chemistry) 1 minute (general chemistry)Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface optional add-on/yes (additional cost) — —LIS interfaces up and running in active user sites all major LIS vendors — —LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems yes, Beckman Coulter automation systemsModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/validate for the DxC 600i yes/yes/yes yes/yes/validate for the DxC 680i

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — — —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel — — —Onboard maintenance records/Maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/online help with maintenance instructions

List price/Targeted bed size or daily volume $325,000/moderate volume, <300 samples per day $575,000/high volume, 300–750 samples per day $610,000/high volume, 300–750 samples per dayAnnual service contract cost (24 hours/7 days) per negotiated contract per negotiated contract per negotiated contractTraining provided with purchase/Advanced operator training yes/yes yes/yes yes/yes



performs parallel processing of immunoassay and chemistry tests on one system; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

performs parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

performs parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability




JUNE 2017 page 43

Part 6 of 21 Beckman Coulter Beckman Coulter bioMérieux Inc.Sharon Stieg [email protected] Sharon Stieg [email protected] Customer Service Team [email protected]


250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Bvld., Brea, CA 92821 100 Rodolphe St., Durham, NC 27712714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com 800-682-2666 www.biomerieux-usa.com

Name of instrument/First year sold/Where designed UniCel DxC 860i Synchron Access Clinical System/2009/U.S. UniCel DxC 880i Synchron Access Clinical System/2008/U.S. VIDAS 3/2013/ItalyCountry where manufactured/Where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland Italy/FranceNumber of units in clinical use in U.S./Outside U.S. >10/>25 >40/>150 —Operational type/Model type/Sample handling system continuous random access/floor standing/rack-closed tube continuous random access/floor standing/rack-closed tube random access, continuous random access/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 68 × 155 × 48/51.7 68 × 161 × 48/53.7 24 × 29.5 × 25.5/5.2Tests available on instrument in U.S. cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR,

vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others


procalcitonin (PCT), D-dimer exclusion, Lyme IgG, Lyme IgM, C. difficile GDH, C. difficile toxin A&B, measles IgG, mumps IgG, rubella IgG, varicella IgG, HCG, H. pylori, toxo IgG, toxo IgM

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg

confirmatory, CMV IgG, CMV IgM, rubella IgMHAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM

ferritin; NT-proBNP; CK-MB; high sensitive troponin I; troponin I Ultra; X protein C, von Willebrand factor (allergen-specific IgG for research only); LH, FSH, estradiol II, progesterone, prolactin, testosterone, cor-tisol S; Staller test, Stallertroph, Stallergy; TSH, FT4, T3, T4, TSH3G, anti-TPO, anti-TG, FT3; toxo; TSPA; AFP, CEA-(S), FPSA, CA 15-3, CA 19-9, CA 125-II; CMV, EBV, HIV, HBs Ag, anti-HBs, anti-HBc total, HBc IgM, HBe-anti-HBe, HAV IgM, anti-HAV total, anti-HCV, rotavirus; C. difficile, H. pylori IgG, vitamin D, total IgE, others

Tests in development AMH AMH —Tests not available on other manufacturers’ analyzers — — Lyme IgG, Lyme IgM

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — 1 test per stripNumber of wells in microplate — — —Methods supported/Separation methods chemiluminescence, enzyme immunoassay/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particle fluorescence, enzyme immunoassay, enzyme immunoassay

coated, solid phase receptacle pipetting device/—Number of different measured assays onboard simultaneously 120 120 12Number of different assays programmed, calibrated at once 120 120 total menuNumber of user-definable (open) channels 100 100 —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set



unit-dose format 30 or 60/30 or 60

Shortest/Median onboard reagent stability/Refrigerated onboard 14 days/28 days/yes (2°–10°C) 14 days/28 days/yes (2°–10°C) —/—/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/specific cartridge ID, number of available tests, expiration

date, lot number, calibration expiration, within lot calibrationyes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration

yes/assay name, lot number, calibration, expiration

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/<10 ppm yes/<10 ppm no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 60/112/assay dependent 60/112/assay dependent assay dependent/27/12System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/125 no/125 no/32 dilution cups onboardUses washable cuvettes/Replacement frequency yes/— yes/— no/—Minimum specimen volume required container dependent container dependent 100–200 µL, dependent on assayMinimum sample volume aspirated precisely at once/Minimum dead volume 3 µL/80 µL 3 µL/20 µL (general chemistry) 100 µL, dependent on assay/100 µL, dependent on assaySupplied with UPS (backup power)/Requires floor drain yes/yes yes/— yes/noRequires dedicated water system/Water consumption yes/up to 16 L per hour yes/up to 16 L per hour no/—

Noise generated — — —Has dedicated pediatric sample cup/Dead volume yes/— yes/— yes/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes yes/16 x 100 mm, 13 x 100 mm, 13 x 75 mm, 12 x 75 mm,

Nalgen cups size: 13, 5 x 38, 1 mm/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes noMeasures number of tests remaining/Short sample detection yes/yes yes/yes no/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes yes/yes (general chemistry) yes/yesDilution of patient samples onboard/Automatic rerun capability yes/yes yes/— yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/yes yes/yes no/no

Time between initial result and reaspiration of sample for rerun chemistry dependent chemistry dependent —Autocalibration or autocalibration alert — — yesNumber of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/28 days no/28 days yes/14 or 28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yes

How often QC required 24 hours 24 hours as per local policyOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/remains in ready mode no/no/remains in ready mode yes/yes/5 minutesStat time to completion of βhCG test 15 minutes 15 minutes 30 minutesTime delay from ordering stat test to aspiration of sample 1 minute (general chemistry) 1 minute (general chemistry) no delayThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry) 12/36 (20 minutes)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface — — onboard/yes (additional cost)LIS interfaces up and running in active user sites — — Misys, Medtech, McKesson, Advanced Lab Systems, Citation,

Cerner, Dawning, Geneysis, Compulab, othersLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes no/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — — within 24 hoursMean time between failures/To repair failures — — 385 days/—Average time to complete maintenance by lab personnel — — weekly: 10–15 minutesOnboard maintenance records/Maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/noList price/Targeted bed size or daily volume $615,000/high to very high volume, 500–1,500 samples per day $650,000/high to very high volume, 750–2,250 samples per day —Annual service contract cost (24 hours/7 days) per negotiated contract — —Training provided with purchase/Advanced operator training yes/yes — —Distinguishing features (supplied by company)


parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

performs parallel processing of immunoassay and chemistry tests; ClozCap technology eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

routine batch testing as well as emergency stat testing, single-dose assay format readily adaptable to batch or single test runs; full traceability with preanalytic automation with barcoding throughout, bi-directional connectivity and remote support; ELISA methodology; dual-function combination solid phase and pipetting device results in no fluid contact with instrument or sample carryover




JUNE 2017 page 44

Part 7 of 21 bioMérieux Inc. Bio-Rad Laboratories Clinical Diagnostics Group Bio-Rad Laboratories Clinical Diagnostics GroupCustomer Service Team [email protected] Greg Stewart [email protected] Greg Stewart [email protected]


100 Rodolphe St., Durham, NC 27712 4000 Alfred Nobel Drive, Hercules, CA 94547 4000 Alfred Nobel Drive, Hercules, CA 94547800-682-2666 www.biomerieux-usa.com 800-224-6723 (800-2BIO-RAD) www.bio-rad.com 800-224-6723 (800-2BIO-RAD) www.bio-rad.com

Name of instrument/First year sold/Where designed VIDAS Immunoassay Analyzer/1991/U.S. PR4100 Microplate Reader/2012/Austria PhD Ix System/2012/FranceCountry where manufactured/Where reagents manufactured Italy/France Austria/U.S. France/U.S.Number of units in clinical use in U.S./Outside U.S. 2,200/25,000 85/10 62/—Operational type/Model type/Sample handling system batch, random access/benchtop/— batch/benchtop/— batch/benchtop/reagent rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet VIDAS 30: 16 × 32 × 2/4.5; MiniVIDAS: 21 × 21 × 17/4 — 30 × 36 × 27/16

Tests available on instrument in U.S. procalcitonin (PCT), D-dimer exclusion, Lyme IgG, Lyme IgM, TSH, HCG, LH, FSH, estradiol 2, progesterone, C. difficile GDH, troponin I, CKMB, C. difficile toxin A&B, mumps IgG, rubella IgG, varicella IgG, H. pylori, toxo competition, toxo IgG, toxo IgM, toxo avidity, CMV IgG, CMV IgM, measles IgG, others

HIV, HBsAg, HBs, HAV, HAV IgM, HBc, HBc IgM, HCV, syphilis, measles, mumps, VZV, Lyme, toxoplasma, ANA, SSA, SSB

open system, method file consists of autoimmune and infectious disease assays, both EIA and IFA methodologies


Tests not available in U.S. but available in other countries HBs Ag, anti-HBs total, anti-HBc total, anti-HBc IgM, anti-HBe, HAV IgG, anti-HAV total, HIV duo, myoglobin, others

— —

Tests in development vitamin D — —

Tests not available on other manufacturers’ analyzers Lyme IgG, Lyme IgM — —

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit 1 test per strip — —Number of wells in microplate — 96 (minimum: 1; maximum: 8) 96 (minimum: 1; maximum: 96)

Methods supported/Separation methods fluorescence, enzyme immunoassay, enzyme immunoassay coated, solid phase receptacle pipetting device/—

enzyme immunoassay/coated microwell fluorescence, enzyme immunoassay/coated microwell

Number of different measured assays onboard simultaneously MiniVIDAS: 12; VIDAS: 30 — 8 enzyme immunoassay or 4 IFANumber of different assays programmed, calibrated at once total menu — 8 enzyme immunoassay or 4 IFANumber of user-definable (open) channels — — no limitNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

unit-dose format 30 or 60/— — up to 8 different assays/96

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no —/—/no 4 hours/—/noMultiple reagent configurations supported no no yesReagent container placed directly on system for use yes — yesReagents barcoded/Information in barcode yes/assay name, lot number, calibration, expiration — no/—Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero — yes/—Walkaway capacity in minutes/Specimens/Tests, assays assay dependent/12–30/12–30 — —/192/8 EIA or 4 IFASystem is open (homebrew methods can be used)/Liquid or dry system no/dry yes/dry yes/liquidUses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— —Minimum specimen volume required 100–200 µL, dependent on assay 70 µL 150 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 100 µL, dependent on assay/— — 1 µL/150 µLSupplied with UPS (backup power)/Requires floor drain yes/no no/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes no/—/no no/—/— yes/12–13 mm diameter, 75–100 mm height/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A no — yesOnboard test auto inventory (determines volume in container) no — noMeasures number of tests remaining/Short sample detection no/no — no/noAutomatic detection of adequate reagent or specimen no — yesClot detection/Reflex testing capability no/no — no/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no — no/noDilution of patient samples onboard/Automatic rerun capability no/no — yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no — no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert yes — noNumber of calibrators required for each analyte — — assay dependentCalibrants can be stored onboard/Average calibration frequency no/14 or 28 days, assay dependent — no/each runMultipoint calib. supported/Multiple calibs. stored for same assay no/yes — yes/no

How often QC required shortest interval: 8 hours; longest: 24 hours — each runOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes — no/no

Automatic shutdown/Startup is programmable/Startup time no/no/always remains ready — no/no/<5 minutes

Stat time to completion of βhCG test 30 minutes — —Time delay from ordering stat test to aspiration of sample no delay — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

—/VIDAS: 20; MiniVIDAS: 8; VIDAS: 60; MiniVIDAS: 24 — assay dependent/—

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes — no/noData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) — onboard/—LIS interfaces up and running in active user sites Misys, Medtech, McKesson, Advanced Lab Systems, Citation,

Cerner, Dawning, Geneysis, Compulab, others— —

LIS interface operates simultaneously with running assays yes — yesBidirectional interface capability yes (broadcast download) — yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no — noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/yes/yes — no/no/no

Can order (via modem) malfunctioning part(s) without operator no — noOn-site response time of service engineer within 24 hours — 24 hoursMean time between failures/To repair failures VIDAS: 860 days; MiniVIDAS: 1,200 days/— — —Average time to complete maintenance by lab personnel weekly: 10–15 minutes — daily: <5 minutes; weekly: 15 minutes; monthly: 30 minutesOnboard maintenance records/Maintenance training demo module yes (includes audit trail)/— — no/no

List price/Targeted bed size or daily volume — — —/all bed sizes

Annual service contract cost (24 hours/7 days) — — —

Training provided with purchase/Advanced operator training — — 2 days on site/no



routine batch testing as well as emergency stat testing; ELISA methodology; dual-function combination solid phase and pipetting device results in no fluid contact with instrument or sample carryover; single-dose assay format readily adaptable to batch or single test runs

— open platform with assay programming wizard; bidirectional LIS with broadcast download, capable of running IFA and EIA; accurate down to 1 µL, IFA hyperwash for cleaner backgrounds, precise well-to-well timing; networking capabilities for multiple workstations




JUNE 2017 page 45

Part 8 of 21 Bio-Rad Laboratories Clinical Diagnostics Group Bio-Rad Laboratories Clinical Diagnostics Group Diamedix, an Erba Diagnostics CompanyMaria Crisostomo [email protected] Greg Stewart [email protected] Steve Joyce [email protected]


4000 Alfred Nobel Drive, Hercules, CA 94547 4000 Alfred Nobel Drive, Hercules, CA 94547 14100 NW 57th Court, Miami Lakes, FL 33014800-224-6723 (800-2BIO-RAD) www.bio-rad.com 800-224-6723 (800-2BIO-RAD) www.bio-rad.com 305-324-2300 www.erbadiagnostics.com

Name of instrument/First year sold/Where designed BioPlex 2200/2006/Australia EVOLIS/2001/Germany Mago 4S Touch/2017/ItalyCountry where manufactured/Where reagents manufactured Australia/U.S. Germany/U.S. Italy/U.S.Number of units in clinical use in U.S./Outside U.S. — 300/1,350 40 (earlier versions)/150 (earlier versions)Operational type/Model type/Sample handling system continuous random access/floor standing/rack batch/benchtop/rack batch, random access/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 58 × 72 × 34/12 37 × 44 × 30/10 27.5 × 47.25 × 26/—

Tests available on instrument in U.S. ANA screen, anti-dsDNA (quant.), anti-SS-A, anti-SS-B, anti-Sm/RNP, anti-Sm, anti-RNP, anti-Scl-70, anti-Jo-1, anti-centromere B, anti-chromatin, anti-ribosomal P, anti-CCP, anti-GBM IgG, anti-MPO IgG, anti-PR3 IgG, EBV NA-1 IgG, EBV VCA IgG, EBV EA-D IgG, EBV VCA IgM, heterophile IgM, syphilis total, RPR, syphilis IgG, T. gondii IgG, CMV IgG, rubella IgG (quant.), T. gondii IgM, CMV IgM, rubella IgM, measles IgG, mumps IgG, rubella IgG (qual.), VZV IgG, HSV-1 IgG, HSV-2 IgG, anti-deamidated gliadin (DGP) IgA, anti-tissue transglutaminase (tTG) IgA, anti-DGP IgG, anti-tTG IgG, anti-cardiolipin IgA, anti-beta2 glycoprotein (β2GPI) IgA, anti-cardiolipin IgG, anti-β2GPI IgG, anti-cardiolipin IgM, anti-β2GPI IgM, 25-OH vitamin D, HIV Ag-Ab screen, HIV-1 p24 antigen, HIV-1 antibody, HIV-2 antibody

HIV Ab, HIV Ab/Ag, HBsAg, HBs, HBc, HBc M, HAV, HAV M 120+

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — HCV Ab, toxo IgG, toxo IgM, rubella IgG, EBV VCA IgG, EBV VCA

IgM, EBV EAD, EBV EBNA, infectious disease serology and autoimmune, others

400+

Tests in development Lyme borreliosis — —

Tests not available on other manufacturers’ analyzers heterophile antibodies — —

Fully automated microplate system no yes yesNumber of each analyte performed in separate disposable unit — — 1Number of wells in microplate — minimum strip: 1; maximum full plate: 96 96 (minimum: 1 strip; maximum: 12 full plates)Methods supported/Separation methods bead flow cytometric (multiplex)/magnetic particle enzyme immunoassay/coated microwell enzyme immunoassay/coated microwellNumber of different measured assays onboard simultaneously 48 4–8 —Number of different assays programmed, calibrated at once 48 4–8 14Number of user-definable (open) channels — — unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

48/100 (HIV and vitamin D: 48/200) 4/96 14/96

Shortest/Median onboard reagent stability/Refrigerated onboard 30 days/30 days/yes (2°–8°C) 30 minutes/assay dependent/— —/—/noMultiple reagent configurations supported no yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/kit type, lot number, kit serial number yes/— yes/lot and expirationSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/<1 ppm no/no (disposable tips) no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 480 minutes/800/9,600 varies by assay/180/4 90/120/14System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid yes/liquidUses disposable cuvettes/Maximum number stored yes/800 microplates/— yes/120Uses washable cuvettes/Replacement frequency no/— microplates/— no/—Minimum specimen volume required 5 µL 0.2 µL 50 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/220 µL 10 µL/200 µL 1 µL/50 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/—Requires dedicated water system/Water consumption no/0.5 L per hour no/— no/—Noise generated <67 decibels 60 decibels —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–16 mm diameter, 41–100 mm height/no yes/up to 16 mm diameter, up to 100 mm height/no yes/all/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes no yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes no/no yes/yesAutomatic detection of adequate reagent or specimen yes no yesClot detection/Reflex testing capability yes/yes yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

— no/no no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert yes no yesNumber of calibrators required for each analyte assay dependent assay dependent 1–6Calibrants can be stored onboard/Average calibration frequency no/30 days no/with each run yes/per runMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/no yes/no

How often QC required 24 hours user determined —Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/—

Automatic shutdown/Startup is programmable/Startup time no/yes/10 minutes no/no/5 minutes no startup or shutdown required


100/100 (36 seconds) assay dependent/— —

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/no onboard/yes onboard/yes (included in instrument price)LIS interfaces up and running in active user sites Antrim, CCA, Cerner Classic/Millennium, CHCS/SAIC, Data

Innovations, Labsoft, Meditech, Orchard, Rubicon, SCC, Schuyler, SOFT, Sunquest/Misys

yes numerous

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes yes (broadcast download) yes (host query)Interface available (or will be) to auto specimen handling system no no —Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/no/no no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <24 hours 24 hours next dayMean time between failures/To repair failures — — >120 days/1 hourAverage time to complete maintenance by lab personnel daily: 5 minutes; weekly: 30 minutes daily: 5 minutes; monthly: 60 minutes daily: 0 minutes; weekly: 0 minutes; monthly: 0 minutesOnboard maintenance records/Maintenance training demo module yes/no yes/no no/noList price/Targeted bed size or daily volume —/as many as 800 samples per day —/30–500 tests per day —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 5 days at Bio-Rad/no 5 days in Redmond, Wash./no 5 days on site, 5 days at vendor office/yes



full random access automation; three internal quality control beads run simultaneously with each sample (assay dependent); innovative multiplex chemistry; compatible track line connectivity option

fully automated microplate system meets high level of safety (positive identification of samples, reagents, microplates, clot detection, no contamination), flexibility (reagents and microplates), and productivity (4–6 plates, up to 180 specimens, 4–8 different assays can be processed simultaneously)

simultaneous ELISA/IFA processing




JUNE 2017 page 46

Part 9 of 21 DiaSorin Dynex Technologies Dynex TechnologiesBrian Lauber [email protected] Rich Bahlmann [email protected] Rich Bahlmann [email protected]


1951 Northwestern Ave., Stillwater, MN 55082 14340 Sullyfield Circle, Chantilly, VA 20151 14340 Sullyfield Circle, Chantilly, VA 20151800-328-1482/651-439-9710 www.diasorin.com 703-631-7800 www.dynextechnologies.com 703-631-7800 www.dynextechnologies.com

Name of instrument/First year sold/Where designed LIAISON XL/2010/Italy DS2/2005/U.S. DSX/2001/U.S.Country where manufactured/Where reagents manufactured Germany/Italy, Germany, U.S. U.S./worldwide U.S./worldwideNumber of units in clinical use in U.S./Outside U.S. >450/>2,500 800/1,500 1,200/1,800Operational type/Model type/Sample handling system batch, random access, continuous random access/floor

standing/rackbatch/benchtop/rack batch/benchtop/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 59 × 59 × 36/14.6 26 × 21 × 27/3.79 32 × 42 × 36/7

Tests available on instrument in U.S. 25 hydroxyvitamin D total, treponema IgG/IgM, anti-HAV total, measles IgG, mumps IgG, Borrelia burgdorferi, EBV IgM, VCA IgG, EA IgG, EBNA IgG, VZV IgG, rubella IgG, rubella IgM testosterone, estradiol, TSH, HSV-1 type specific IgG, HSV-2 type specific IgG, CMV IgG, direct renin, aldosterone, LH, FSH, intact PTH, toxo IgG, toxo IgM, CMV IgM, insulin, C-peptide, hGH, IGF-1, prolactin, progesterone, hCG, FT3, FT4, 1,25 dihydroxyvitamin D, PTH 1-84, H. pylori IgG, anti-HAV IgM

open system, tests provided by various manufacturers open system, tests provided by various manufacturers


Tests not available in U.S. but available in other countries Ca 125, Ca 15-3, Ca 19-9, TPA-M, AFP, CEA, PSA, fPSA, S100, NSE, calprotectin, Brahms procalcitonin II, many others

— —


Tests not available on other manufacturers’ analyzers — none none

Fully automated microplate system no yes yesNumber of each analyte performed in separate disposable unit — 1 per well 1 per wellNumber of wells in microplate — 96 (minimum: 1 strip; maximum: 2 full plates) 96 (minimum: 1 strip; maximum: 4 full plates)

Methods supported/Separation methods chemiluminescence/magnetic particle enzyme immunoassay/coated microwell enzyme immunoassay/coated microwellNumber of different measured assays onboard simultaneously 25 assay dependent (24 control positions) assay dependent (33 control positions)Number of different assays programmed, calibrated at once 25 assay dependent (24 control positions) assay dependent (33 control positions)Number of user-definable (open) channels 0 unlimited unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

25/100 assay dependent (18 reagent positions)/96 assay dependent (24 reagent positions)/96

Shortest/Median onboard reagent stability/Refrigerated onboard 7 days/28 days/yes (12°C) —/—/no —/—/noMultiple reagent configurations supported no yes yesReagent container placed directly on system for use yes yes, 2 mL control vials (other reagents are pour off) yes (when using custom racks)Reagents barcoded/Information in barcode yes/quantity, stability, lot number, and more no/— yes/lot information when used with custom racksSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/no yes/none (uses disposable tips) yes/none (uses disposable tips)Walkaway capacity in minutes/Specimens/Tests, assays 7 days/120/3,000 assay dependent/100/assay dependent assay dependent/assay dependent/4+System is open (homebrew methods can be used)/Liquid or dry system no/liquid yes/liquid yes/liquidUses disposable cuvettes/Maximum number stored yes/1,000 no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required assay dependent 10 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/150 µL 10 µL/— 10 µL/—Supplied with UPS (backup power)/Requires floor drain yes/— yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume yes/50 µL no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–16 mm diameter/no yes/10–16 mm diameter, 40–100 mm height/no yes/12–16 mm diameter, 55–100 mm height/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/—Barcode placement per CLSI standard Auto2A yes — —Onboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/no yes/—Hemolysis detection-quantitation/Turbidity detection-quantitation no/no — —Dilution of patient samples onboard/Automatic rerun capability yes/yes yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun 2 minutes — —Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte 2 assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency yes/1–4 weeks no/per plate no/per plateMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/noHow often QC required 24 hours per plate per plateOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes no/stored curve capability no/noAutomatic shutdown/Startup is programmable/Startup time yes/no/8 minutes no/no/— no/no/—

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample 2 minutes — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

57/171 (21 seconds) — —

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/no onboard/yes (additional cost) onboard/yes (additional cost)LIS interfaces up and running in active user sites — yes yesLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (host query and broadcast download) yes (host query and broadcast download)Interface available (or will be) to auto specimen handling system yes (Inpeco) — —Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes no/yes/yes no/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours contract dependent contract dependentMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel weekly: 10 minutes; monthly: 10 minutes daily: <15 minutes; weekly: <75 minutes;

monthly: <5 hoursdaily: <15 minutes; weekly: <75 minutes; monthly: <5 hours

Onboard maintenance records/Maintenance training demo module yes/no yes/no yes/no

List price/Targeted bed size or daily volume —/>300 beds $51,709/2–4 plates $72,282/4–6 platesAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/yes additional/yes additional/yes



secure traceability of all processes, status of reagents, and consumables; disposable pipette tips prevent sample carryover; clot detection, aspiration, and dispensation verification; single-cavity reaction cuvettes; no daily maintenance; monitors maintenance needs; flash chemiluminescence technology with paramagnetic microparticle solid phase

washer synchronization, eliminates plate drift; disposable tips; small footprint

washer synchronization, eliminates plate drift; modular design; disposable tips




JUNE 2017 page 47

Part 10 of 21 Dynex Technologies Fujirebio US Gold Standard DiagnosticsRich Bahlmann [email protected] Matthew Bell [email protected] Nicholas Garrone [email protected]


14340 Sullyfield Circle, Chantilly, VA 20151 205 Great Valley Parkway, Malvern, PA 19355 2851 Spafford St., Davis, CA 95618703-631-7800 www.dynextechnologies.com 844-544-3787 www.fujirebio.us 530-759-8000 www.gsdx.us

Name of instrument/First year sold/Where designed Agility/2012/U.S., U.K. Lumipulse G1200/U.S.: 2016; outside U.S.: 2008/Japan AIX1000 Agglutination Instrument/2016/U.S.Country where manufactured/Where reagents manufactured U.S./worldwide Japan/Japan U.S./U.SNumber of units in clinical use in U.S./Outside U.S. 50/50 1/1,018 —Operational type/Model type/Sample handling system batch/benchtop/rack continuous random access/floor standing/rack batch/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 49 × 50 × 36/8.6 56 × 45 × 30/32.45 20.75 × 24.5 × 24/4.1

Tests available on instrument in U.S. open system, tests provided by various manufacturers CA125, HE4, vitamin D, ROMA, syphilis nontreponemal RPR

Tests not available in U.S. but submitted for clearance — E2, FSH, LH, progesterone, prolactin, TSH —

Tests not available in U.S. but available in other countries — procalcitonin, AFP, CEA, CA 15-3, CA 19-9, PSA, free PSA, CYFRA, PIVKA-II, ProGRP, SMRP, PLAP, pepsinogen I, pepsinogen II, B2M (S), B2M (U), HBsAg-quant, HBsAb, HBcAb, HBcIgM, HBeAg, HBeAb, HBcrAg, HAVAb, HAVIgM, HIV ½, HIV Ag/Ab, HTLV-I, HBsAg-qual, HCV Ab, HCV Ag, HIV-1p24, C-peptide (S), C-peptide (U), insulin, ferritin, adiponectin-HMW, ApoB48, TSH, FT3, FT4, T3, T4, TgAb, TPOAb, testosterone, β-HCG, BNP, IgE, IL-6, KL-6, L-FABP, β-amyloid 1-42

—

Tests in development — AMH, wPTH, HTLV-I/II, troponin I, CK-MB, myoglobin, total TAU, pTAU

—

Tests not available on other manufacturers’ analyzers none LFABP, adiponectin, SMRP, HBcrAg nontreponemal RPR

Fully automated microplate system yes no noNumber of each analyte performed in separate disposable unit 1 per well — —Number of wells in microplate 96 (minimum: 1 strip; maximum: 12 full plates) — —

Methods supported/Separation methods enzyme immunoassay/coated microplate wells chemiluminescence/magnetic particle agglutination/—Number of different measured assays onboard simultaneously 12 36 1Number of different assays programmed, calibrated at once 12 36 1Number of user-definable (open) channels unlimited — —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

12/96 36/14 1/480

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no 720 hours/30 days/yes (2°–12°C) —/—/noMultiple reagent configurations supported yes no noReagent container placed directly on system for use yes requires operator prehandling, preparation yesReagents barcoded/Information in barcode yes/lot information yes/lot number, expiration date, master calibration curve, sequence no/—Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/none (uses disposable tips) no/<0.1 ppm no/—Walkaway capacity in minutes/Specimens/Tests, assays assay dependent/200+ continuous load/12+ continuous load 50/100/24 90/192/1System is open (homebrew methods can be used)/Liquid or dry system yes/liquid no/liquid no/liquid Uses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 10 µL 10–140 µL (assay dependent) 105 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/150 µL 10 µL/250 µL tube, 100 µL cup 1 µL/200 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/no no/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — 65 decibles —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–17 mm diameter, 45–100 mm depth/no yes/outer diameter 11.5–16.0 mm, length 75–100 mm/no yes/12, 13, 16 mm/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/—Barcode placement per CLSI standard Auto2A — yes yesOnboard test auto inventory (determines volume in container) yes yes noMeasures number of tests remaining/Short sample detection yes/yes yes/yes no/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/no yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert no yes noNumber of calibrators required for each analyte assay dependent most analytes use 2–3 points —Calibrants can be stored onboard/Average calibration frequency no/per plate no/30 days no/—Multipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/yes no/noHow often QC required per plate user defined shortest interval: 1 day; longest: 1 dayOnboard real-time QC/Support multiple QC lot Nos. per analyte no/no —/yes yes/noAutomatic shutdown/Startup is programmable/Startup time yes/yes/15 minutes yes/yes/5 minutes no/no/<5 minutes

Stat time to completion of βhCG test — 30 minutes —Time delay from ordering stat test to aspiration of sample — 1 minute —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— 40/120 tests per hour (30 seconds) —

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) no/yes (additional cost) onboard/noLIS interfaces up and running in active user sites yes — —LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (host query and broadcast download) yes (host query) noInterface available (or will be) to auto specimen handling system no yes (Inpeco, IDS, Aloka, Hitachi) noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes no/no/no —/yes/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer contract dependent 24–48 hours 24 hoursMean time between failures/To repair failures — >330 days/— —Average time to complete maintenance by lab personnel daily: <15 minutes; weekly: <75 minutes; monthly: <5 hours daily: 15 minutes; weekly: 45 mintes; monthly: 90 minutes daily: <5 minutes; weekly: <20 minutes

Onboard maintenance records/Maintenance training demo module yes/no no/no yes/no

List price/Targeted bed size or daily volume $124,848/8+ plates $75,000/50–500 beds —Annual service contract cost (24 hours/7 days) — $10,000 —Training provided with purchase/Advanced operator training additional/yes 2 days/no 2 days on site/yes



reduces hands-on time by more than 60 percent for ELISA testing; tracks all assays, test kits, consumables, reagents, and waste so analyzer can run without interruption

unitized immunoreaction cartridge eliminates open bottle stability concerns; 30 minute time to result for all assays; uninterrupted productivity—replenish samples, reagents, and consumables on the fly

fully automated nontreponemal RPR screens and titers; automated processing, analysis, interpretation and result archival




JUNE 2017 page 48

Part 11 of 21 Gold Standard Diagnostics Grifols/AESKU GrifolsChristina Brusca [email protected] Micah Majarian [email protected] Micah Majarian [email protected]


2851 Spafford St., Davis, CA 95618 4560 Horton St., Emeryville, CA 94608 4560 Horton St., Emeryville, CA 94608530-759-8000 www.gsdx.us 800-379-0957 www.grifols.com 800-379-0957 www.grifolsusa.com

Name of instrument/First year sold/Where designed ThunderBolt/2012/U.S. HELIOS/2012/Germany Triturus/1999/SpainCountry where manufactured/Where reagents manufactured U.S./— Germany/Germany Spain/Spain, U.S., ItalyNumber of units in clinical use in U.S./Outside U.S. 100/500 —/300+ >200/>1,700Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/rack batch, continuous random access/benchtop/universal carouselDimensions in inches (H × W × D)/Instrument footprint in sq. feet 17.7 × 25.2 × 22.5/4 22.5 × 25.6 × 29.6/5.25 28.3 × 41.3 × 34.3/10

Tests available on instrument in U.S. — ANA HEp-2 open system: most U.S. clinically cleared and research-use-only EIA procedures can be programmed; infectious diseases, autoimmune diseases, bone markers, endocrinology, hemostasis, oncology markers, hepatitis, and HIV profiles


Tests not available in U.S. but available in other countries — ANCA, Crithidia, LKS, EMA —



Fully automated microplate system yes no yesNumber of each analyte performed in separate disposable unit — — 8Number of wells in microplate 96 — 96 (minimum strip: 1; maximum: 4 full plates)

Methods supported/Separation methods chemiluminescence, enzyme immunoassay/coated microwell fluorescence, indirect fluorescent antibody/coated IFA slide enzyme immunoassay, EIA-coated microwell plates, onboard shaker, 4 individually temperature-controlled microplate positions/coated microwell

Number of different measured assays onboard simultaneously 8 4 1–8 tests on 1–4 platesNumber of different assays programmed, calibrated at once 8 4 8Number of user-definable (open) channels — — —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

8/— 4/120 8/48

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no —/—/no —/—/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes minimal operator preparation, handlingReagents barcoded/Information in barcode no/— — no/—Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/— no/none yes/noWalkaway capacity in minutes/Specimens/Tests, assays ~240, assay dependent/192/8 —/190/1 180/92/8System is open (homebrew methods can be used)/Liquid or dry system yes/liquid no/liquid yes/liquid Uses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 100 µL tube dependent 300 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 1 µL/100 µL tube dependent/tube dependent 2 µL/200 µLSupplied with UPS (backup power)/Requires floor drain no/no no/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12, 13, 16 mm/no yes/11–16 mm wide, 55–100 mm tall/no yes/12, 13, 16 mm/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A no — yesOnboard test auto inventory (determines volume in container) no no yesMeasures number of tests remaining/Short sample detection no/yes no/yes yes/yesAutomatic detection of adequate reagent or specimen no no yesClot detection/Reflex testing capability no/no no/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

— no/no no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert no no yesNumber of calibrators required for each analyte kit dependent — 1–14Calibrants can be stored onboard/Average calibration frequency no/kit dependent — no/check every monthMultipoint calib. supported/Multiple calibs. stored for same assay yes/no — yes/yesHow often QC required kit dependent (shortest: every plate; longest: per batch) shortest interval: 1 slide; longest: 20 slides each runOnboard real-time QC/Support multiple QC lot Nos. per analyte no/no no/no yes/noAutomatic shutdown/Startup is programmable/Startup time no/no/5 minutes no/no/<5 minutes yes/yes/1–2 minutes

Stat time to completion of βhCG test — — system is open, depends on reagent methodologyTime delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

kit dependent/kit dependent — dependent on reagent methodology/—

Can autotransfer QC results to LIS/Onboard capability to review QC no/no no/yes yes/yesData-management capability/Instrument vendor supplies LIS interface no/yes (included) onboard/no onboard/noLIS interfaces up and running in active user sites Harvest, LabDaq, MediTech 5.65, Sunquest, Data Innovations — CHCS, Softmax, Sunquest, othersLIS interface operates simultaneously with running assays no yes yesBidirectional interface capability yes (host query) yes (host query) yes (host query and broadcast download)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no no/no/no yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 48 hours — within 24 hoursMean time between failures/To repair failures —/~2 hours — —Average time to complete maintenance by lab personnel daily: 5 minutes; weekly: 30 minutes daily: 15 minutes; weekly: 20 minutes daily: 5–15 minutesOnboard maintenance records/Maintenance training demo module yes/no no/no yes (includes audit trail)/yes

List price/Targeted bed size or daily volume —/380 tests per day $155,925/200+ beds $79,000/300+ Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 2 days on site/yes — yes/yes



can process EIA + CLIA; aspirate 1 µL with less than 3% CV; no disposables or consumables

provides all-in-one IFA HEp-2 slide processing and reading on one platform; FDA cleared to identify 7 HEp-2 patterns, plus negative results; uses pattern recognition software and estimates the endpoint titer (EPT)

multibatch or continuous throughput EIA analyzer; user-defined menu, completely open system; easy color-coded worksheet and setup for operator; 2 probes for high-speed processing; unique cross-well washing; can use fixed probes or disposable tips




JUNE 2017 page 49

Part 12 of 21 Hycor Biomedical Immunodiagnostic Systems (IDS) Inova DiagnosticsRichard Hockins [email protected] [email protected] Jackie Gonzalez-Rubio [email protected]


7272 Chapman Ave., Garden Grove, CA 92841 948 Clopper Rd., Gaithersburg, MD 20878 9900 Old Grove Rd., San Diego, CA 92131800-382-2527 www.hycorbiomedical.com 877-852-6210 www.idsplc.com 858-586-9900 www.inovadx.com

Name of instrument/First year sold/Where designed HYTEC 288 PLUS/outside U.S.: 1998; U.S.: 1999/Netherlands IDS-iSYS/2009/France BIO-FLASH/2011/U.S.Country where manufactured/Where reagents manufactured Netherlands/U.S. France/Belgium U.S./U.S.Number of units in clinical use in U.S./Outside U.S. >85/>200 >80/>700 —Operational type/Model type/Sample handling system random batches/benchtop/rack robotics continuous random access/benchtop/rack sample loading continuous random access/benchtop/racksDimensions in inches (H × W × D)/Instrument footprint in sq. feet 29.5 × 42.5 × 27.5/8 28 × 42 × 30/~6 21 × 34 × 24/5

Tests available on instrument in U.S. total/specific IgE, ANA scr, TG, TPO, dsDNA, RF IgG, RF IgM, RF IgA, PR-3 (c-ANCA), MPO (p-ANCA), anti-mitochondrial, ENA-6 scr., SS-A, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, gliadin IgA & IgG, GBM, GPC, anti-cardiolipin IgG & IgM, anti-cardiolipin scr., β2 BPI IgG, IgA & IgM, user-defined channels

1,25-dihydroxy vitamin D, 25 hydroxy vitamin D, insulin-like growth factor-I (IGF-I), human growth hormone (hGH), insulin-like growth factor binding protein-3 (IGFBP-3), CTX-I (CrossLaps), intact PTH, PTH (1-34) (for research use only), direct renin, aldosterone, 25 hydroxy vitamin DS

tTG IgA, tTG IgG, DGP IgA, DGP IgG, aCL IgG, aCL IgM, aCL IgA, B2GP1 IgG, B2GP1 IgM, B2GP1 IgA, MPO, PR3, GBM, ENA 7, RNP, Sm, centromere, SS-B, Jo-1, Ro52, Ro60, B2GP1-domain 1, dsDNA, CCP3, Scl-70

Tests not available in U.S. but submitted for clearance — intact PINP, ostase BAP, N-MID osteocalcin —

Tests not available in U.S. but available in other countries specific IgG, ssDNA, total RF, anti-tissue transglutaminase IgA & IgG, circulating immune complex -C1q and -C3d, CCP

1,25 VitDXp, intact PINP, N-MID osteocalcin, ostase BAP, TRAcP5b, salivary cortisol, 17-OH progesterone, ACTH, total testosterone, InaKtif MGP

CTD screen plus, DFS70, ribosomal P, fecal calprotectin, LKM-1, M2 (MIT3)

Tests in development ANCA profile, centromere cortisol, 17-beta estradiol, free testosterone —

Tests not available on other manufacturers’ analyzers — TRAcP5b, free testosterone, inaKtif MGP, 17-OH progesterone CCP3, B2GP1-domain 1, DFS70

Fully automated microplate system yes no noNumber of each analyte performed in separate disposable unit 8 (1 analyte, multiple analytes/screens per well, up to 8

analytes)— —

Number of wells in microplate 96 (minimum strip: 1 strip/8 wells; maximum full plate: 12 strips/96 wells)

— —

Methods supported/Separation methods enzyme immunoassay, tube-based and microplate-based assays/activated cellulose and coated well

chemiluminescent and spectrophotometric/ magnetic particle

chemiluminescence/magnetic particle, bead

Number of different measured assays onboard simultaneously varies by assay, up to 288 allergens or 8 autoimmune 15 20Number of different assays programmed, calibrated at once multiple 15 —Number of user-definable (open) channels 3 0 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

varies by assay/up to 288 allergens or 8 autoimmune 15/100 20/50 and 100 test kits

Shortest/Median onboard reagent stability/Refrigerated onboard 8 hours/12 hours/no 7 days/56 days/yes (12°–15°C) varies by analyte/varies by analyte/yes (1.5°–6°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode no/— yes/lot, key information yes/type, number of tests, lot number, expiration date, master

calibration curveSame capabilities when 3rd-party reagents used/Susceptibility to carryover yes/<1 part in 10,000 no/no no/—Walkaway capacity in minutes/Specimens/Tests, assays assay dependent/100/288 assay dependent/120/15 —/30/20System is open (homebrew methods can be used)/Liquid or dry system yes/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— yes/up to 1,120 yes/280Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 10 µL, 110 µL with dead volume 6 µL (assay dependent) 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL –50 µL, assay dependent/100 µL 4 µL/80 µL 10 µL/50 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume no/— yes/80 µL yes/50 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/—/no yes/all up to 16 × 100 mm/no yes/12–16 mm/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A no yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability no/no yes/no yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no yes/yes

Time between initial result and reaspiration of sample for rerun — dependent on run cycle or immediately after first result 30 minutesAutocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 1–6 2 2Calibrants can be stored onboard/Average calibration frequency no/monthly no/3–21 days no/lot changeMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required every assay daily dailyOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/no/2–3 minutes yes/yes/<10 minutes yes/yes/<10 minutes

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample — — < 5 minutesThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— >26/>80 (every 45 seconds) 20/60 (30 minutes)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/optional onboard/no (additional cost) onboard/yes (included)LIS interfaces up and running in active user sites yes yes —LIS interface operates simultaneously with running assays no yes yesBidirectional interface capability yes yes (broadcast download) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/no yes/yes/yes yes/yes/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer within 48 hours 24–48 hours 24 hoursMean time between failures/To repair failures 7 months/4 hours >200 days/<24 hours —Average time to complete maintenance by lab personnel daily: 10–15 minutes; weekly: 20–25 minutes;

monthly: 20–25 minutesdaily: 5 minutes; weekly: 10 minutes; monthly: 10 minutes

weekly: 5 minutes; monthly: 15 minutes

Onboard maintenance records/Maintenance training demo module yes (includes audit trail of who replaced parts)/yes yes (includes audit trail)/no yes/no

List price/Targeted bed size or daily volume $55,000/all sites, variable test volumes —/all bed sizes, all volumes —/100–500Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 3 days on site/yes 3 days on site/yes yes/yes



fully automated allergy and autoimmune testing; user-defined software channels for microtiter plate and tube-based assays

full walkaway automation; compact benchtop design; continu-ous loading with batch, random, and stat flexibility; auto startup and shut down; onboard refrigeration of ready-to-use reagent cartridges; total traceability and full data transmitted to the LIS (results, QC, lot reagents and consumables, mes-sages, operator ID, washer used, and more); intelligent clot management (iCM) prevents measurement interruption and enhances productivity via maximized up time

random access, continuous load, chemiluminescent, benchtop footprint; completes up to 450 results per shift; onboard reagents with stable calibration curves to eliminate batching and improve turnaround time




JUNE 2017 page 50

Part 13 of 21 Inova Diagnostics Inova Diagnostics Inova DiagnosticsJackie Gonzalez-Rubio [email protected] Jackie Gonzalez-Rubio [email protected] Ed Bass [email protected]


9900 Old Grove Rd., San Diego, CA 92131 9900 Old Grove Rd., San Diego, CA 92131 9900 Old Grove Rd., San Diego, CA 92131858-586-9900 www.inovadx.com 858-586-9900 www.inovadx.com 858-586-9900 www.inovadx.com

Name of instrument/First year sold/Where designed DS2/2006/U.S. DSX/2000/Guernsey, U.K. QUANTA-Lyser 240/2008/Switzerland, ItalyCountry where manufactured/Where reagents manufactured U.S./U.S., U.K. U.S./U.K. Switzerland/U.S.Number of units in clinical use in U.S./Outside U.S. — 300/>500 135/171Operational type/Model type/Sample handling system batch, with continuous load/benchtop/rack batch/benchtop/rack batch/benchtop/racksDimensions in inches (H × W × D)/Instrument footprint in sq. feet 30 × 17 × 26/3.07 32 × 42 × 36/7 36 × 47 × 32/10.5

Tests available on instrument in U.S. autoimmune, infectious disease autoimmune, infectious disease open system: autoimmune, infectious disease


Tests not available in U.S. but available in other countries ELISA any ELISA —



Fully automated microplate system yes yes yesNumber of each analyte performed in separate disposable unit — — —

Number of wells in microplate minimum strip 1 × 8; maximum full plate: 96 wells × plates minimum strip: 1 × 8; maximum full plate: 96 × 4 plates 96

Methods supported/Separation methods enzyme immunoassay/coated microwell enzyme immunoassay/coated microwell enzyme immunoassay/coated microwell, IFA slides

Number of different measured assays onboard simultaneously 12 assays per plate 12 assays per plate 12–22Number of different assays programmed, calibrated at once unlimited unlimited —Number of user-definable (open) channels unlimited unlimited open systemNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

8/96 25/96 per 4 plates enzyme immunoassay/IFA

Shortest/Median onboard reagent stability/Refrigerated onboard 24 hours/—/no 24 hours/—/no —/—/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes requires operator prehandling, preparation requires prehandlingReagents barcoded/Information in barcode yes/yes yes/yes —Same capabilities when 3rd-party reagents used/Susceptibility to carryover —/zero with disposable tips yes/zero —/<10Walkaway capacity in minutes/Specimens/Tests, assays assay dependent/98/assay dependent assay dependent/92/assay dependent assay dependent/up to 240/9 quantitative, 21 qualitativeSystem is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid yes/liquidUses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 200 µL 200 µL 200 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/200 µL (50 µL with microtubes) 5 µL/200 µL (50 µL with microtubes) 5 µL/200 µLSupplied with UPS (backup power)/Requires floor drain yes/— yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume yes/50 µL yes/50 µL no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/—/no yes/various/no yes/10–16 mm/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes —Onboard test auto inventory (determines volume in container) no no noMeasures number of tests remaining/Short sample detection no/yes no/yes no/yesAutomatic detection of adequate reagent or specimen yes yes noClot detection/Reflex testing capability yes/no yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no —Dilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no —

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte varies assay specific assay dependentCalibrants can be stored onboard/Average calibration frequency yes/each assay yes/once per analyte per plate no/per runMultipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/yes yes/noHow often QC required each assay per plate per runOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/no yes/no no/yesAutomatic shutdown/Startup is programmable/Startup time no/yes/1–2 minutes yes/—/1–2 minutes no/no/2 minutes


assay dependent/— assay dependent/— —

Can autotransfer QC results to LIS/Onboard capability to review QC —/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/yes (additional cost) onboard/yes (additional cost)LIS interfaces up and running in active user sites — Cerner Classic and Millennium, Misys, SoftComp,

Live Link, Triple G, FCC, ACA, LCW, LabLinkCerner Classic and Millennium, Misys, SoftComp

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (host query) yes (host query) yes (host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no no/yes/yes no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — within 24 hours 24 hoursMean time between failures/To repair failures —/<24 hours —/<24 hours 8–9 months/less than 2 hoursAverage time to complete maintenance by lab personnel daily: 5 minutes daily: 5 minutes daily: 5 minutes; weekly: 10 minutes

monthly: 10 minutes

Onboard maintenance records/Maintenance training demo module yes/no no/no no/—

List price/Targeted bed size or daily volume — —/200+ beds —/500 tests per dayAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 8 days on site/yes 8 days on site, 2 days at vendor offices/yes yes (2 days on site)/yes



graphic interface with drag-and-drop icons; large sample throughput, with 98 samples and continuous load feature; consumable status window shows location and volume requirements during loading

fully open, true four-plate system; modular design of reader, washer, incubators; barcode reader and ambient drawer enables easy upgrades and express shipping of replacement modules, reducing downtime; software can be configured for learned error recovery

fast processing time; low operating costs due to elimination of disposable tips; completely open high-throughput batch analyzer; reads IFA barcodes




JUNE 2017 page 51

Part 14 of 21 Inova Diagnostics Inova Diagnostics Ortho Clinical Diagnostics Ed Bass [email protected] Ed Bass [email protected] 1001 U.S. 202


9900 Old Grove Rd., San Diego, CA 92131 9900 Old Grove Rd., San Diego, CA 92131 Raritan, NJ 08869858-586-9900 www.inovadx.com 858-586-9900 www.inovadx.com 800-828-6316 www.orthoclinical.com

Name of instrument/First year sold/Where designed QUANTA-Lyser 2/2008/— QUANTA-Lyser 4000/2016/Switzerland VITROS ECi Immunodiagnostic System/1997/U.S.Country where manufactured/Where reagents manufactured Switzerland/U.S. Switzerland/Switzerland U.S./U.K.Number of units in clinical use in U.S./Outside U.S. 5/72 — >500/>1,700 Operational type/Model type/Sample handling system batch/benchtop/racks batch/benchtop/rack continuous random access/floor standing/universal sample

trays (circular) accommodate primary and secondary containers without need for adapters

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 29.5 × 25.6 × 27.6/— 36 × 60 × 30/15 51 × 44 × 29/8.9

Tests available on instrument in U.S. open system: autoimmune, infectious disease NOVA Lite IFA slides 3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total βhCG, estradiol, progesterone, LH, FSH, prolactin, NTx, CEA, AFP, CA 125 II, CA 15-3, ferritin, cortisol (serum and urine), CK-MB, troponin I, aHBs, B12, folate, RBC folate, equimolar PSA, HBsAg, aHCV, HBsAg (conf.), myoglobin, aHBc, aHBc IgM, aHBs, testosterone, NT-proBNP, CA 19-9, aHAV total, aHAV IgM, rubella IgG, aHIV 1+2, iPTH, HBeAg, aHBe, vitamin D


Tests not available in U.S. but available in other countries — — HIV Combo, toxo IgG, rubella IgM, toxo IgM, CMV IgG, CMV IgM, syphilis, free PSA, total PSA II

Tests in development — — C-peptide, insulin, syphilis, high sensitivity troponin

Tests not available on other manufacturers’ analyzers — — NTx

Fully automated microplate system yes no noNumber of each analyte performed in separate disposable unit — — 1Number of wells in microplate 96 — —

Methods supported/Separation methods enzyme immunoassay, IFA slides/coated microwell IFA slide processor/none (all assays homogeneous) chemiluminescence (enhanced)/individually coated microwellNumber of different measured assays onboard simultaneously 7 — 20Number of different assays programmed, calibrated at once — — 20, up to 25 lots calibrated per assayNumber of user-definable (open) channels open system — 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

enzyme immunoassay/IFA 5/240 20/100

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no 10 hours/1 day/no 56 days/56 days/yes (2° –8°C)Multiple reagent configurations supported yes no yesReagent container placed directly on system for use requires prehandling yes yesReagents barcoded/Information in barcode yes/— yes/ID, lot, expiration date yes/test ID, expiration, lot number, pack IDSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/<10-6 no/zero —/zeroWalkaway capacity in minutes/Specimens/Tests, assays —/—/64 IFA, 96 enzyme immunoassay 300/480/480 720/60/2,000 (with enhanced productivity module)System is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid no/liquid Uses disposable cuvettes/Maximum number stored no/— — no/—Uses washable cuvettes/Replacement frequency no/— — no/—Minimum specimen volume required 100 µL 250 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/150 µL 100 µL/200 µL 10 µL/80 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/— no, but it is available/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — 60 decibelsHas dedicated pediatric sample cup/Dead volume no/— yes/100 µL no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–16 mm/no yes/12–16 mm/no yes/multiple pediatric, microtainers, and cups, 5 mL,

7 mL, 10 mL on same universal sample tray/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interl., Codabar, codes 39 & 128 & ISBT 128)/yesBarcode placement per CLSI standard Auto2A — yes yesOnboard test auto inventory (determines volume in container) no no yesMeasures number of tests remaining/Short sample detection no/yes no/yes yes/yesAutomatic detection of adequate reagent or specimen — yes yes

Clot detection/Reflex testing capability yes/no yes/no yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

— no/no no/no

Time between initial result and reaspiration of sample for rerun — — assay dependentAutocalibration or autocalibration alert no no yesNumber of calibrators required for each analyte varies — 1–3Calibrants can be stored onboard/Average calibration frequency —/per run no/— no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/no yes/yes

How often QC required per run each run once per 24 hours

Onboard real-time QC/Support multiple QC lot Nos. per analyte no/— no/no yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/2 minutes yes/yes/15 minutes —

Stat time to completion of βhCG test — — 24 minutesTime delay from ordering stat test to aspiration of sample — — immediate upon completion of last sample meteringThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— — assay dependent/assay dependent (40 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) optional add-on/no onboard and optional add-on/noLIS interfaces up and running in active user sites — — Cerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA,

Citation, DHCP, Unisys, McKesson, PathLab 3, Soft, othersLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download, host query) yes (host query) yes (broadcast download)Interface available (or will be) to auto specimen handling system no — noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/—/— no/no/no yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator — no noOn-site response time of service engineer 24 hours — <4 hours (contract dependent)Mean time between failures/To repair failures 6–8 months/— — dependent on corrective actionAverage time to complete maintenance by lab personnel daily: 5 minutes; weekly: 10 minutes;

monthly: 10 minutesdaily: 15 minutes; weekly: 30 minutes; monthly: 30 minutes

daily: <5 minutes; weekly: <30 minutes; monthly: <10 minutes

Onboard maintenance records/Maintenance training demo module no/— — no/yes

List price/Targeted bed size or daily volume — — $109,000/variousAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes (2 days on site)/— yes (2 days on site, 3 days at vendor offices)/yes yes/yes, as needed



processes IFA slides and ELISA assays simultaneously, LIS interface, large menu, and open-assay capability; reads IFA barcodes

automated IFA slide barcode scanning; automated reagent bottle barcode scanning; pipettes mounting media onto IFA slides

uses Intellicheck Technology to perform, monitor, document, and verify diagnostic checks throughout sample and assay processing to reduce potential of misreported results; Intelli-Report provides real-time status and traceability on quality of reported results; uses enhanced chemiluminescence, MicroWell technology

JUNE 2017 page 52




Part 15 of 21 Ortho Clinical Diagnostics Randox Toxicology Roche Diagnostics1001 U.S. 202 David Ferguson [email protected] Ryan Dempsey [email protected]


Raritan, NJ 08869 55 Diamond Rd., Crumlin, County Antrim, BT29 4QY 9115 Hague Rd., Indianapolis, IN 46250800-828-6316 www.orthoclinical.com 0044 28 9442 2413 www.randoxtoxicology.com 800-428-5074 us.diagnostics.roche.com

Name of instrument/First year sold/Where designed VITROS 3600 Immunodiagnostic System/2009/U.S. Evidence/2002/Northern Ireland cobas e 801 module (8000 modular analyzer series)/2017/JapanCountry where manufactured/Where reagents manufactured U.S./U.K. Northern Ireland/Northern Ireland Japan/GermanyNumber of units in clinical use in U.S./Outside U.S. >150/>400 8/27 —Operational type/Model type/Sample handling system continuous random access/floor standing/universal sample

trays (circular) accommodate primary and secondary containers without need for adapters

batch/floor standing/carousel random access, continuous random access/floor standing/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 68 × 83.5 × 34.9/20.2 68 × 78 × 39/22.75 63.8 × 58.8 × 44.9/—Tests available on instrument in U.S. 3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total βhCG,

estradiol, progesterone, LH, FSH, prolactin, NTx, CEA, AFP, CA 125 II, CA 15-3, ferritin, cortisol (serum and urine), CK-MB, troponin I, aHBs, B12, folate, RBC folate, equimolar PSA, HBsAg, aHCV, HBsAg (conf.), myoglobin, aHBc, aHBc IgM, aHBs, testosterone, NT-proBNP, CA 19-9, aHAV total, aHAV IgM, rubella IgG, aHIV 1+2, iPTH, vitamin D

acetaminophen, amphetamine, barbiturates, bath salts (alpha PVP, MDPV, methcathinone, mephedrone), benzodiazepine, benzlpiperazines, buprenorphine, cannabinoids, carbamazepine, chloral hydrate metabolite, cocaine metabolite, dextromethorphan, digoxin, dox series, EDDP, escitalopram, ethanol, ethyl glucuronide, fentanyl, flunitrazepam, fluoxetine, generic opiods, gentamicin, haloperidol, ibuprofen, ketamine, lithium, LSD, MDMA, meperidine, meprobamate, mescaline, methadone, methamphetamine, methaqualone, methylphenidate, mitragynine (kratom), NBOMe, nor buprenorphine, nor fentanyl, opiates, oxycodone, phencyclidine, phenobarbital, phenylpiperazines, phenytoin, many more

—

Tests not available in U.S. but submitted for clearance aHBe, HBeAg, NephroCheck, HIV Combo, insulin — —Tests not available in U.S. but available in other countries aHBe, HBeAg, rubella IgM, toxo IgG, toxo IgM, CMV IgG, CMV

IgM, syphilis, free PSA, total PSA II, HIV Combo, NephroCheck— —

Tests in development C-peptide, syphilis, high sensitivity troponin — —Tests not available on other manufacturers’ analyzers NTx bath salts (alpha PVP, MDPV, methcathinone, mephedrone), dox

series, mitragynine (kratom), NBOMe, synthetic cannabinoids (JWH- 018/AM-2201, JWH-250/RCS-8, UR144 / XLR11, AKB48, AB PINACA)

—

Fully automated microplate system no — noNumber of each analyte performed in separate disposable unit 1 — —Number of wells in microplate — — —Methods supported/Separation methods chemiluminescence (enhanced)/individually coated microwell chemiluminescence/— electrochemiluminescence/magnetic particleNumber of different measured assays onboard simultaneously 31 22 48 per moduleNumber of different assays programmed, calibrated at once 31, up to 25 lots calibrated per assay 22 48 per moduleNumber of user-definable (open) channels — 0 —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

31/100 44/360 48/100–300 tests per kit

Shortest/Median onboard reagent stability/Refrigerated onboard 42 days/56 days/yes (2°–8°C) assay dependent/up to expiration/yes (2°–8ºC) 112 days/112 days/yes (6°–10°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/test ID, expiration date, lot number, pack ID yes/product component, size, lot number, expiration date yes/RFID tag: calibration curve, application parameters,

lot number, expiration, reagent nameSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero — —/zero (uses disposable sample tips)Walkaway capacity in minutes/Specimens/Tests, assays varies/90/3,100 100/180/540–1,080 —System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— no/— yes/1,575Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 10 µL 7 µL 4 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/35 µL 7 µL/350 µL (varies with cup type) 4 µL/50 µLSupplied with UPS (backup power)/Requires floor drain no, but it is available/no optional/yes yes/yesRequires dedicated water system/Water consumption no/— no/— yes/30 L per hour in full operationNoise generated 60 decibels <60 decibels <65 decibelsHas dedicated pediatric sample cup/Dead volume no/— no/— yes/50 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/1.5 mL micro-collection containers; 0.5, 2.0 mL cups;

5, 7, 10 mL on same universal sample tray, no adapters/noyes/12 mm, 16 mm/no yes/13 × 75, 13 × 100, 16 × 75, 16 × 100/no

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interl., Codabar, codes 39 & 128 & ISBT 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes no/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes no/no yes/yesDilution of patient samples onboard/Automatic rerun capability yes/yes no/no yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun assay dependent assay dependent —Autocalibration or autocalibration alert yes no yesNumber of calibrators required for each analyte 1–3 depending on assay 9 (multianalyte calibrators) 2Calibrants can be stored onboard/Average calibration frequency no/28 days no/dependent on panel no/84 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required once per 24 hours each worklist 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time — yes/yes/13 minutes yes/yes/6 minutes (in Quick Start Mode)

Stat time to completion of βhCG test 24 minutes — 9 min. incubation for hCG and 18 min. incubation for βhCG Time delay from ordering stat test to aspiration of sample immediate upon completion of last sample metering — <1 minuteThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/assay dependent (19 seconds) assay dependent/assay dependent (5 minutes) 100/300 (12 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard and optional add-on/no onboard/yes (included in price) onboard/yesLIS interfaces up and running in active user sites Cerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA,

Citation, DHCP, Unisys, McKesson, PathLab 3, othersyes all major LISs

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, enGen no yes (cobas 8100 system, CCM, task-targeted automation)Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <4 hours (contract dependent) <24 hours (contract dependent) <24 hoursMean time between failures/To repair failures dependent on corrective action — —/variesAverage time to complete maintenance by lab personnel daily: 10 minutes; weekly: 25 minutes; monthly: 15 minutes daily: 5 minutes; weekly: 10 minutes; monthly: 30 minutes 4–5 minutes hands-on daily maintenanceOnboard maintenance records/Maintenance training demo module yes (includes audit trail)/yes no/— yes (includes audit trail)/yes

List price/Targeted bed size or daily volume $220,000/various contract dependent/various —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/yes, as needed yes/yes 3 days at company offices/yesDistinguishing features (supplied by company)


Intellicheck Technology process checks reduce misreported results and provide real-time quality status and traceability on each result; single-use tips for sample and reagent metering; MicroSensor Technology detects hem., ict., and turbidity without using any reagents or additional sample and without increasing result TAT; load on-the-fly consumables

biochip enables simultaneous analysis of multiple analytes in single sample; maximum throughput of 1,188 tests per hour; unreported tests retrieved retrospectively; arrays contain multiple tests applicable to forensic toxicology and workplace drug testing

high productivity (300 tests per hour; 48 reagent channels); smallest immunoassay sample volumes; fastest 9-minute STAT assays; industry-leading onboard reagent and calibration stability




JUNE 2017 page 54

Part 16 of 21 Roche Diagnostics Roche Diagnostics Roche DiagnosticsRyan Dempsey [email protected] Brittany Greiner [email protected] Ryan Dempsey [email protected]


9115 Hague Rd., Indianapolis, IN 46250 9115 Hague Rd., Indianapolis, IN 46250 9115 Hague Rd., Indianapolis, IN 46250800-428-5074 us.diagnostics.roche.com 800-428-5074 us.diagnostics.roche.com 800-428-5074 us.diagnostics.roche.com

Name of instrument/First year sold/Where designed cobas 8000 modular analyzer series/2010/Japan, Switzerland cobas e411 analyzer/2008/Japan cobas 6000 analyzer series/2006/Japan, SwitzerlandCountry where manufactured/Where reagents manufactured Japan/Germany Japan/Germany Japan/GermanyNumber of units in clinical use in U.S./Outside U.S. — — —Operational type/Model type/Sample handling system random access, continuous random access/floor standing/

rack-basedcontinuous random access/benchtop/rack, disk continuous random access/floor standing/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 52.8 × 58.8 × 45.6/— disk: 31.4 × 47.2 × 28.7/94; rack: 31.4 × 67 × 37.4/17.4 46.1 × 71.8 × 40/19.73Tests available on instrument in U.S. ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBs,

anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, rubella IgM, SHBG, T3, T4, testosterone, anti-HBc, anti-HBc IgM, CMV IgM, vitamin D, CMV IgG, toxo IgG, anti-HBe, AMH, cyfra 21-1, HE4 + CA 125 ROMA PCT, syphilis, troponin T fifth generation

ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBc IgM, anti-HBs, anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, rubella IgM, SHBG, T3, T4, testosterone, total PSA, toxo IgG, troponin I, troponin T, anti-HBc, CMV IgM, vitamin D, CMV IgG, anti-HBe, AMH, cyfra 21-1, HE4 + CA 125 ROMA PCT, syphilis, troponin T fifth generation

ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBc IgM, anti-HBs, anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, anti-HBc, vitamin D, toxo IgM, toxo IgG, anti-HBe, AMH, cyfra 21-1, HE4 + CA 125 ROMA PCT, syphilis, troponin T fifth generation

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries free βhCG, PAPP-A, PTH (1-84), HBeAg, HIV Ag, HIV Ag

confirmatory test, HIV duo, othersfree βhCG, PAPP-A, PTH (1-84), HBeAg, HIV Ag, HIV Ag confirmatory test, HIV duo, toxo IgM, CMV IgG, others

free βhCG, PAPP-A, PTH (1-84), HBeAg, anti-HBe, HIV Ag, HIV Ag confirmatory test, HIV duo, others

Tests in development tacrolimus, sirolimus, cyclosporine, Interleukin 6, HIV combi, toxo IgM

tacrolimus, sirolimus, cyclosporine, Interleukin 6, HIV combi, toxo IgM

tacrolimus, sirolimus, cyclosporine, PCT, Interleukin 6, HIV combi, toxo IgM

Tests not available on other manufacturers’ analyzers 9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more 9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more 9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, moreFully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —Methods supported/Separation methods electrochemiluminescence/magnetic particle electrochemiluminescence/magnetic particle electrochemiluminescence/magnetic particle

Number of different measured assays onboard simultaneously 25 per module, maximum of 60 18 25 per module, maximum of 60Number of different assays programmed, calibrated at once 25 per module 18 25 per moduleNumber of user-definable (open) channels — 0 —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

25/100–200 tests per kit 18/100–200 tests per kit 25/100–200 tests per kit

Shortest/Median onboard reagent stability/Refrigerated onboard 2 weeks/6 weeks/yes (20°C) 14 days/56 days/yes 2 weeks/6 weeks/yes (20°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/calibration curve, application parameters,

lot number, expiration, reagent nameyes/calibration curve, application parameters, lot number, expiration, reagent name

yes/calibration curve, application parameters, lot number, expiration, reagent name

Same capabilities when 3rd-party reagents used/Susceptibility to carryover —/zero (uses disposable sample tips) no/zero (uses disposable sample tips) —/zero (uses disposable sample tips)Walkaway capacity in minutes/Specimens/Tests, assays 360/300/5,000 disk: 120/30/180; rack: 120/100/180 360/150/5,000System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/1,006 per module yes/360 assay tips; 180 assay cups yes/1,006 per moduleUses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 10 µL 10 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/100 µL 10 µL/100 µL 10 µL/100 µLSupplied with UPS (backup power)/Requires floor drain yes/yes yes/no yes/yesRequires dedicated water system/Water consumption yes/average 12 L per hour in full operation no/3 L for 250 tests yes/average 12 L per hour in full operationNoise generated <65 decibels <70 decibels <65 decibelsHas dedicated pediatric sample cup/Dead volume yes/100 µL no/— yes/100 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75, 16 × 100, false bottom/no yes/13–16 mm diameter/no yes/13 × 75, 16 × 100, false bottom/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

Barcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes (data manager) yes/yes (with middleware) yes/yes (with Roche Middleware Solutions)Hemolysis detection-quantitation/Turbidity detection-quantitation yes/yes, semiquantitative with integrated system no/no yes/yes, semiquantitative with integrated systemDilution of patient samples onboard/Automatic rerun capability yes/yes yes/no yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no yes/yes no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 2 2 2Calibrants can be stored onboard/Average calibration frequency no/28 days no/monthly for lot, weekly for rack no/every 28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours once per day 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/11 minutes yes/no/4 minutes yes/yes/11 minutesStat time to completion of βhCG test 9 min. incubation for hCG and 18 min. incubation for βhCG 9 minutes 9 min. incubation for hCG and 18 min. incubation for βhCG Time delay from ordering stat test to aspiration of sample <1 minute 42 seconds <1 minuteThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

56/176 (21 seconds) 30/86 (42 seconds) 56/176 (21 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/— onboard/yes (additional cost) onboard/yes (additional cost)LIS interfaces up and running in active user sites all major LISs — all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes (cobas 8100 system, task-targeted automation) yes yes (cobas 8100 system, task-targeted automation)Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes yes/yes/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <24 hours <24 hours ≤24 hoursMean time between failures/To repair failures 184 days (cobas e602 module)/varies 221 days (cobas e411 module)/varies 229 days (cobas e601 module)/variesAverage time to complete maintenance by lab personnel 4–5 minutes hands-on daily maintenance daily: 5 minutes; weekly: 6 minutes; monthly: 10–15 min. 3–5 minutes of hands-on daily maintenanceOnboard maintenance records/Maintenance training demo module yes (includes audit trail)/yes (online help) no/no yes (includes audit trail)/yes (online help)

List price/Targeted bed size or daily volume —/large to very large —/varies, primary immunoassay system or backup unit —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 5 days at company offices/yes 4 days on site/yes 5 days at company offices/yesDistinguishing features (supplied by company)


ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and barcoded reagents compatible with other Elecsys systems; range of stat assays with 9-minute assay time, integral part of c8000 platform; connects with cobas 8100 automated workflow series

ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and barcoded reagents fully compatible with other Elecsys systems; range of stat assays with 9-minute assay time

ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and barcoded reagents compatible with other Elecsys systems; range of stat assays with 9-minute assay time, integral part of c8000 platform; connects with cobas 8100 automated workflow series




JUNE 2017 page 55

Part 17 of 21 Siemens Healthineers Siemens Healthineers Siemens HealthineersJoseph Amodeo [email protected] Tiia Maxwell [email protected] John Dabney [email protected]


511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591847-267-5393 www.usa.siemens.com/diagnostics 847-267-5393 www.usa.siemens.com/diagnostics 877-229-3711 www.usa.siemens.com/diagnostics

Name of instrument/First year sold/Where designed Dimension EXL 200/2011/U.S. Dimension Vista 500 Intelligent Lab System/2009/U.S. ADVIA Centaur CP Immunoassay System/2005/U.S.Country where manufactured/Where reagents manufactured U.S./U.S. U.S./U.S., Germany Switzerland/U.S.Number of units in clinical use in U.S./Outside U.S. >1,900 worldwide >1,000 worldwide >557/>2,801Operational type/Model type/Sample handling system batch, random access/floor standing/segmented sample

wheelcontinuous random access/floor standing/rack and aliquot plate system, batch

continuous random access/benchtop/7 × 12 position racks

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 61 × 56 × 41/16 56 × 85 × 44/26 32 × 43 × 29/8.7Tests available on instrument in U.S. >100 (includes vendor-supported applications), tacrolimus,

MPA, LOCI sensitive troponin I, LOCI NT-proBNP, LOCI TSH, LOCI free T4, LOCI free T3, sirolimus, total PSA, free PSA, CardioPhase hsCRP, ferritin, HCG, LV HCG, mass CK-MB, LV mass CK-MB, myoglobin, ammonia, urine/CSF protein, lactic acid, microalbumin, prealbumin, carbamazepine, cyclosporine, cyclosporine extended range, digoxin, digitoxin, gentamicin, lidocaine, lithium, N-acetylprocainamide, LOCI folate, LOCI B12, many others

>130 (includes vendor-supported applications), 35 general chemistry, 14 TDMs, 17 DATs, 3 anemia, 40 plasma proteins, 20 immunoassays, including sensitive troponin I, NT-proBNP, cyclosporine, LH, FSH, prolactin, CA 19-9, CA 125, CA 15-3, progesterone

total IgE, ferritin, folate, RBC folate, vitamin B12, vitamin D total, BNP, CKMB, myoglobin, Tnl-ultraTM, C-peptide, insulin, eHIV 1/O/2, HAV IgM, HAV total, HBc IgM, HBc total, HBsAg, HBsAg confirmatory, HCV, cyclosporine, cortisol, homocysteine, AFP, BR, CA 15-3, CA 19-9, CA 125II, CEA, complexed PSA, PSA, serum HER2/neu, DHEAS, enhanced estradiol, FSH, total hCG, LH, progesterone, prolactin, SHBG, testosterone, rubella IgG, rubella IgM, syphilis, anti-HBs2, others

Tests not available in U.S. but submitted for clearance — testosterone —Tests not available in U.S. but available in other countries >35 >20 (including vendor-supported applications) procalcitonin, HA, TIMP, PIIINP (ELF markers)

Tests in development vitamin D, high sensitive troponin I high sensitive troponin I vitamin D, D-dimer, galectin-3, anti-HBe, HBeAg, HIV combo (CHIV), tacrolimus, free PSA, PIGF, sFLT-1, CMV IgG, CMV IgM

Tests not available on other manufacturers’ analyzers — LOCI immunoassay, nephelometric assays, gen. chemistry complexed PSA, serum HER2/neu


Methods supported/Separation methods photometry, potentiometry (ISE), turbidimetric and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

photometry, potentiometry (ISE), turbidimetric, nephelometry and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

chemiluminescence/magnetic particle

Number of different measured assays onboard simultaneously 47 144 15Number of different assays programmed, calibrated at once 47 144 >84 assays and multiple calibration lotsNumber of user-definable (open) channels 10 10 —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

47/15–360 144/20–1,200 15/50–200

Shortest/Median onboard reagent stability/Refrigerated onboard 24 hours/30 days/yes (2°–8°C) 24 hours/30 days/yes (2°–8°C) 4 days/28 days/yes (4°C)Multiple reagent configurations supported yes no yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/lot number, unique flex ID, stability, expiration date yes/test method, lot number, expiration date, number of tests yes/reagent ID, lot number, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover yes/none (due to probe washing) yes/<1 ppm no/zeroWalkaway capacity in minutes/Specimens/Tests, assays can be hours/60/>2,000 >45/150/178,800 210/72/480System is open (homebrew methods can be used)/Liquid or dry system yes/liquid (reconstitutes onboard, no reagent prep required) yes/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/12,000 yes/>2,000 yes/400Uses washable cuvettes/Replacement frequency no/— yes/automatic as needed no/—Minimum specimen volume required 2 µL 2 µL analytical, 50 µL 10 µL, assay dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 2 µL/— 2 µL (GLU 1.2 µL)/10 µL 10 µL/50 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/yes yes/noRequires dedicated water system/Water consumption yes/5 L no/20 L per hour no/noneNoise generated <75 decibels <64 decibels <60 decibelsHas dedicated pediatric sample cup/Dead volume yes/30 µL yes/10 µL no (uses microtainers)/50 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/5-, 7-, 10-, 1.5-, and 1.0-mL sample cups/no yes/10 × 50, 10 × 65, 13 × 65, 13 × 75, 13 × 100, 15 × 92,

16 × 100, 13 × 90/noyes/5-, 7-, 10-, 1-mL cups, microtainer tubes/no

Sample barcode reading capability/Autodiscrimination yes, on sample transport, shortly before sample is aspirated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

yes, on sample transport, shortly before sample is aspirated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

Barcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes yes/yes no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/no can decrease/no no (has autodilution)/no (has autodilution)

Time between initial result and reaspiration of sample for rerun <20 seconds <2 minutes variesAutocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte varies (3 levels for most assays) 2–6 (varies) 2Calibrants can be stored onboard/Average calibration frequency yes (NA, K, Cl)/most 90 days yes/30–90 days no/28 days (assay dependent)Multipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours or with lot change once per 24 hours user definedOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/8 minutes no/no/always ready no/always ready/<5 minutesStat time to completion of βhCG test 16 minutes 10 minutes 15 minutesTime delay from ordering stat test to aspiration of sample <24 seconds <2 minutes 20 secondsThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

up to 146/437 (7.2 seconds) >150/450 for immunoassay methods 60/180 (20 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard, optional add-on/yes (additional cost) onboard/no yes/yesLIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Siemens VersaCell, Streamlab, Aptio Automation yes, Siemens, Streamlab, Advia LabCell, Advia WorkCell, Aptio

Automationno

Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 2–8 hours 2–8 hours 2–8 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: <5 minutes; weekly: 10 minutes; monthly: 15 minutes daily: 5 minutes; weekly: 10 minutes; monthly: 10 minutes daily: 15 minutes; weekly: 20 minutes; monthly: 30 minutesOnboard maintenance records/Maintenance training demo module no/no yes/yes yes/yes

List price/Targeted bed size or daily volume — — —/200+ beds or 250 tests per dayAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 3 days at company offices/yes 4 days at company offices/yes 4 days at company offices/yes



integrates general chemistry with homogeneous LOCI and heterogeneous immunoassays onboard; allows a single platform for more than 95% of most requested tests; eliminates sample splitting between general chemistry tests and immunoassays; fully automated onboard ISD assays, QCC PowerPak onboard; reagent management system standard

ultra-integrated chemistry platform with LOCI advanced chemiluminescence and nephelometry onboard; enhanced workflow efficiency with automated features, such as autocalibration, auto QC, and system twinning; proactive service and support through RealTime Solution Siemens Remote Service

automates routine operations, including ability to access/change solutions, waste, disposables, and reagents without pausing sampling or processing; onboard automatic dilu-tions, repeats, stats, and cascade reflex testing; disposable tips; uses same reagents/consumables as Advia Centaur/Advia Centaur XP with concordant results; throughput 180 tests per hour; average time to first result ~15 minutes




JUNE 2017 page 56

Part 18 of 21 Siemens Healthineers Siemens Healthineers Siemens HealthineersJohn Dabney [email protected] Tiia Maxwell [email protected] Joseph Amodeo [email protected]


511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591877-229-3711 www.usa.siemens.com/diagnostics 847-267-5393 www.usa.siemens.com/diagnostics 847-267-5393 www.usa.siemens.com/diagnostics

Name of instrument/First year sold/Where designed ADVIA Centaur XPT Immunoassay System/2014/U.S. Dimension Vista 1500 Intelligent Lab System/2006/U.S. Dimension EXL with LM Integrated Chemistry System/2009/U.S.Country where manufactured/Where reagents manufactured Ireland/U.S. U.S./U.S., Germany U.S./U.S.Number of units in clinical use in U.S./Outside U.S. <10/>400 >1,000 worldwide >1,800 worldwide

Operational type/Model type/Sample handling system random access/floor standing/rack batch, random access, continuous random access/ floor standing/sample rack and aliquot plate system

batch, random access, continuous random access/ floor standing/racks

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 66 × 77 × 41/21.92 56 × 85 × 44/26 49 × 82 × 41 (without monitor)/25.1 (with printer shelf down)

Tests available on instrument in U.S. allergy, anemia/iron metabolism, bone metabolism, cardiac, diabetes, infectious disease, immunosuppressant drugs, metabolic, oncology, reproductive endocrinology, special ID, therapeutic drug monitoring (TDM), thyroid, ToRCH

>130 (includes vendor-supported applications) >100 (includes vendor-supported applications)


Tests not available in U.S. but available in other countries — >20 >35 (includes vendor-supported applications)

Tests in development multiple testosterone, additional hormones vitamin D, high sensitive troponin I

Tests not available on other manufacturers’ analyzers — LOCI technology, nephelometry, general chemistry —


Methods supported/Separation methods acridinium ester, chemiluminescence/magnetic particle photometry, potentiometry (ISE), turbidimetric, nephelometry and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

photometry, potentiometry (ISE), turbidimetric and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

Number of different measured assays onboard simultaneously 30 166 91Number of different assays programmed, calibrated at once 300 166 91Number of user-definable (open) channels — 10 10Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

30/50, 100, 200 tests per pack 166/20–1,200 91/15–360

Shortest/Median onboard reagent stability/Refrigerated onboard 4 days/28 days/yes (4°C) 24 hours/30 days/yes (2°–8°C) 24 hours/30 days/yes (2°–8°C)Multiple reagent configurations supported yes no yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/assay name, lot No., exp. date, pack ID, No. of tests yes/test ID, lot No., individual sequence number, exp. date yes/lot number, unique flex ID, stability, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover —/zero yes/<1 ppm yes/none (due to probe washing)Walkaway capacity in minutes/Specimens/Tests, assays 280/180/840 >45/150/205,200 can be hours/60/>2,000System is open (homebrew methods can be used)/Liquid or dry system no/liquid yes/liquid yes/liquid (reconstitutes onboard, no reagent prep required)Uses disposable cuvettes/Maximum number stored yes/1,000 yes/>2,000 yes/12,000Uses washable cuvettes/Replacement frequency no/— yes/as needed no/—Minimum specimen volume required 10 µL, assay dependent 2 µL analytical, 50 µL 2 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/50 µL 20 µL (GLU=1.2 µL)/10 µL 2 µL/primary tube capableSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/2.5 L per hour no/20 L per hour yes/up to 5 LNoise generated <62 decibels 64 decibels <75 decibelsHas dedicated pediatric sample cup/Dead volume no/— yes/10 µL yes/30 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/1-, 2-, 3-, 5-, 7-, 10-mL, microtainer tubes/no yes/10 × 50, 10 × 65, 13 × 65, 13 × 75, 13 × 100, 15 × 92,

16 × 100, 13 × 90/noyes/5-, 7-, 10-, 1.5-, and 1.0-mL sample cups/no

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes, on sample transport, shortly before sample is aspirated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

yes, on sample transport, shortly before sample is aspirated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

Barcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no yes/yes yes/yesDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no (has autodilution) yes/no

Time between initial result and reaspiration of sample for rerun 15 seconds <2 minutes <20 secondsAutocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 2 2–6 (varies) varies (3 levels for most assays)Calibrants can be stored onboard/Average calibration frequency no/28 days (assay dependent) yes/30–90 days yes (NA, K, Cl)/most 90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required user defined shortest interval: 24 hours 24 hours or with lot changeOnboard real-time QC/Support multiple QC lot Nos. per analyte no/yes yes/yes no/yesAutomatic shutdown/Startup is programmable/Startup time no/no/always ready no/no/always ready no/no/not required

Stat time to completion of βhCG test 18 minutes 10 minutes 16 minutesTime delay from ordering stat test to aspiration of sample 15 seconds <2 minutes <24 secondsThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

80/240 (15 seconds) >150/450 for immunoassay methods up to 146/437 (7.2 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC no/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes onboard/no onboard, optional add-on/yes (additional cost)LIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Advia WorkCell, Advia LabCell, VersaCell, StreamLab, Aptio yes, Siemens VersaCell, Streamlab, Advia LabCell, Advia

WorkCell, Aptio Automationyes, Siemens VersaCell, Streamlab, Aptio Automation

Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 2–8 hours 2–8 hours 2–8 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 5 minutes; weekly: 5 minutes; monthly: 15 minutes daily: 5 minutes; weekly: 10 minutes; monthly: 10 minutes daily: <5 minutes; weekly: 10 minutes; monthly: 10 minutes

Onboard maintenance records/Maintenance training demo module yes/yes yes/yes no/yes

List price/Targeted bed size or daily volume —/300+ beds or 500 tests per day — —Annual service contract cost (24 hours/7 days) multiple options — multiple typesTraining provided with purchase/Advanced operator training 4.5 days on site/yes 4 days at company offices/yes 4 days at company offices/no



on-the-fly loading/unloading of samples, reagents, and supplies; 2-D barcode scanner uploads test definitions; automated daily maintenance, no monthly cleaning procedures; no daily startup procedure; up to 240 tests per hour; stat port allows priority sampling at any time; disposable sample tips; automated clot management; SMART algorithm software automates repeat and confirmatory testing of reactive samples; direct connectivity to Siemens Automation Solutions, CentraLink Data Management System, and Siemens Remote Service (SRS)

intelligent lab system with customer-driven design, ultra-integration of technologies; LOCI advanced chemiluminescence and automation onboard for efficiency, simplicity, sensitivity, and convenience to provide an efficient workflow for the laboratory; autocalibration and auto QC onboard; proactive services and support through RealTime Solution Siemens Remote Service

integrates homogeneous LOCI and heterogeneous immunoassays onboard with other chemistries; allows single platform for >95% of most tests; eliminates sample splitting between general chemistry tests and immunoassays; fully automated onboard ISD assays; QCC PowerPak onboard; reagent management standard




JUNE 2017 page 57

Part 19 of 21 Siemens Healthineers ThermoFisher Scientific ThermoFisher ScientificJohn Dabney [email protected] Nicole Ramsey [email protected] Nicole Ramsey [email protected]


511 Benedict Ave., Tarrytown, NY 10591 4169 Commercial Ave., Portage, MI 49002 4169 Commercial Ave., Portage, MI 49002877-229-3711 www.usa.siemens.com/diagnostics 800-346-4364 www.thermofisher.com 800-346-4364 www.thermofisher.com

Name of instrument/First year sold/Where designed IMMULITE 2000 XPi Immunoassay System/2009/U.S. Phadia Laboratory System 250/2004/Japan, Sweden Phadia Laboratory System 1000/2003/Japan, SwedenCountry where manufactured/Where reagents manufactured U.S./Wales, U.K. Japan, Sweden/Sweden Japan, Sweden/SwedenNumber of units in clinical use in U.S./Outside U.S. >103/>1,283 246/2,135 138/330Operational type/Model type/Sample handling system random access/floor standing/rack continuous random access/floor standing/racks continuous random access/floor standing/racks

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 47 × 60 × 30/12.5 73 × 50 × 30 plus 26-in. wide computer stand/— 83 × 71 × 40 plus 26-in. wide computer stand/—Tests available on instrument in U.S. 3gAllergy specific, total IgE, ferritin, folic acid, RBC folate,

vitamin B12, calcitonin, PYRILINKS-D, high-sensitivity CRP, myoglobin, troponin I, CMV IgG, CMV IgM, herpes I & II IgG, toxo. quantitative IgG, toxo. IgM, rubella quantitative IgG, rubella IgM, C-peptide (serum, urine), insulin, microalbumin (urine) (ALB), growth hormone (hGH), IGF-I, IGFBP-3, anti-HBc IgM, anti-HBc total, anti-HBs, HBs Ag, HBs Ag confirmatory, H. pylori IgG, syphilis, ACTH, cortisol, anti-CCP, TSI, others

hundreds of ImmunoCAP-specific IgE allergens and allergen components, ImmunoCAP-total IgE and tryptase; EliA autoimmune products include anti-TG, anti-TPO, M2, CCP, dsDNA, Symphony ANA Screen, 7 individual ENAs, Celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG/IgA, β2-glycoprotein IgM/IgG/IgA, EliA PR3s, GBM, MPOs

hundreds of ImmunoCAP-specific IgE allergens and allergen components, ImmunoCAP-total IgE and tryptase


Tests not available in U.S. but available in other countries AlaTOP allergy screen, allergen-specific IgG, allergen-specific IgG4, ECP, osteocalcin, CK-MB, D-dimer, NT-proBNP, IL-2R, IL-6, IL8, LBP, free beta HCG, PAPP-A, EBV-EBNA IgG, EBV-VCA IgG, EBV-VCA IgM

EliA CTD screen (15 ENAs), Pm/Scl, EliA anti IgA, EliA calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other “rare” ENAs, RF IgG, and CCP IgA

—


Tests not available on other manufacturers’ analyzers IGF-I, IGFBP-3, androstenedione, β2 microglobulin, gastrin, canine TLI, canine total T4, canine TSH, 3gAllergy-specific IgE

ImmunoCAP-specific IgE blood tests and EliA autoimmune tests

ImmunoCAP-specific IgE blood tests

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —Methods supported/Separation methods chemiluminescence/bead, centrifugation fluoroenzyme immunoassay/ImmunoCAP cellulose polymer

matrix reaction wellsfluoroenzyme immunoassay/ImmunoCAP cellulose polymer matrix reaction wells

Number of different measured assays onboard simultaneously 24 6 3Number of different assays programmed, calibrated at once unlimited not limited, though inventory manager software will instruct

operator of reagent insufficiencies in the onboard inventorynot limited, though inventory manager software will instruct operator of reagent insufficiencies in the onboard inventory

Number of user-definable (open) channels — 0 (closed system) 0 (closed system)Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

24/200 3/400 or 100, depending on the conjugate type 3/400 or 100, depending on the conjugate type

Shortest/Median onboard reagent stability/Refrigerated onboard 90 days/90 days/yes (4°C) 5 days/1 year/yes (2°–8°C) 5 days/1 year/yes (2°–8°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes (wash solution requires preparation) yes (wash solution requires preparation)Reagents barcoded/Information in barcode yes/test, lot number, expiration date yes/product name, lot number, expiration date yes/product name, lot number, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/<3 ppm no/— no/zero (disposable sample tips)Walkaway capacity in minutes/Specimens/Tests, assays 300/90/1,300 470/50 simultaneously/370 tests 460/200 simultaneously/2,400 testsSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/1,300 no/— no/—Uses washable cuvettes/Replacement frequency no/— — —Minimum specimen volume required 5–100 µL 40 µL for ImmunoCAP tests and 20 µL for EliA tests 40 µL per testMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/50 µL 40–200 µL for ImmunoCAP tests and 50 µL/

50–200 µL for EliA tests (varies with tube type)40 µL/40–200 µL (varies with tube type)

Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/10 L no/10 LNoise generated 52 decibels 65 decibels 68 decibelsHas dedicated pediatric sample cup/Dead volume yes/50 µL no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/75–100 mm/no yes/10–17 mm × 50–105 mm/no yes/10–17 mm × 50–105 mm/noSample barcode reading capability/Autodiscrimination yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes no noOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes no/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no (has autodilution)/no (has autodilution) no/no no/no

Time between initial result and reaspiration of sample for rerun minimum 18 seconds 100 minutes 100 minutesAutocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 2-level adjusters, supplied in kit 6 per analyte for calibration run, 2 per analyte when using

stored curve6 per analyte for calibration run, 2 per analyte when using stored curve

Calibrants can be stored onboard/Average calibration frequency no/1–4 weeks (assay dependent) yes/28 days or sooner if conjugate lots change yes/28 days or sooner if conjugate lots changeMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required customer determined once per work shift (user defined) once per work shift (user defined)Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/4 minutes yes/yes/30 minutes unattended yes/yes/30 minutes unattended

Stat time to completion of βhCG test 35 minutes — —Time delay from ordering stat test to aspiration of sample 18 seconds 6 minutes 6 minutesThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

67/200 (18 seconds) 20 specimens/60 (100 minutes to first result, then 1 result per 60 seconds )

80 specimens/240 (100 minutes to first result, then 1 result per 15 seconds )

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface yes/yes onboard/yes (instrument side only) onboard/yes (instrument side only)LIS interfaces up and running in active user sites yes Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem,

American Health Net, Antrim, othersMisys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, others

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Advia WorkCell, Advia LabCell, VersaCell, StreamLab yes yesModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 2–8 hours <24 hours <24 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 5–10 minutes; weekly: 20 minutes; monthly: 20–30

minutesdaily: 1 minute; weekly: 10 minutes; monthly: 15 minutes daily: 1 minute; weekly: 10 minutes; monthly: 15 minutes

Onboard maintenance records/Maintenance training demo module no/yes yes/— yes/—List price/Targeted bed size or daily volume —/>200+ beds or 250 tests per day —/>20,000–95,000 tests per year —/>95,000 tests per yearAnnual service contract cost (24 hours/7 days) multiple options — —Training provided with purchase/Advanced operator training yes/yes 3.5 days at company offices/yes 4.5 days at laboratory/yes



extensive routine and specialty immunoassay menu (81 assays); includes menu of 300+ specific allergens and panels; provides opportunity to reduce sendouts and boost laboratory revenue; features extended reagent onboard stability (90 days) for efficient operation and cost control

provides accepted technology for serologic, specific IgE testing with the ImmunoCAP family of products and autoimmune markers with the EliA family of products; comprehensive clinical and technical research and extensive medical information and education

provides accepted technology for serologic, specific IgE testing with the ImmunoCAP family of products; comprehensive clinical and technical research and extensive medical information and education; measures and reports specific IgE quantitative results across the clinical range

JUNE 2017 page 58




Part 20 of 21 ThermoFisher Scientific ThermoFisher Scientific TOSOH BioscienceNicole Ramsey [email protected] Nicole Ramsey [email protected] Susan Kolarik [email protected]


4169 Commercial Ave., Portage, MI 49002 4169 Commercial Ave., Portage, MI 49002 6000 Shoreline Ct., Ste. 101, South San Francisco, CA 94080800-346-4364 www.thermofisher.com 800-346-4364 www.thermofisher.com 800-248-6764 www.tosoh.com

Name of instrument/First year sold/Where designed Phadia Laboratory System 2500/2011/Sweden Phadia Laboratory System 5000/2011/Sweden AIA-2000/2008/JapanCountry where manufactured/Where reagents manufactured Japan/Sweden Japan/Sweden Japan/JapanNumber of units in clinical use in U.S./Outside U.S. 11/33 1/17 90/700Operational type/Model type/Sample handling system continuous random access/floor standing/racks continuous random access/floor standing/racks continuous random access/floor standing/rack, sorter drawerDimensions in inches (H × W × D)/Instrument footprint in sq. feet 71 × 158 × 47 plus 26-in. wide computer stand/51 71 × 236 × 47 plus 26-inch wide computer stand/77 49.6 × 59.1 × 35.7/14.66

Tests available on instrument in U.S. hundreds of ImmunoCAP-specific IgE allergens and allergen components and ImmunoCAP-total IgE; EliA autoimmune products include M2, anti-TG, anti-TPO, and CCP

hundreds of ImmunoCAP-specific IgE allergens and allergen components and ImmunoCAP-total IgE

TSH 3rd gen., TSH, FT4, FT3, T4, T3, T-uptake, TPOAb, TgAb, bHCG, estradiol, FSH, LH, progesterone, prolactin, AFP, CEA, PSA, CA 125, 27.29, beta 2 microglobulin, C-peptide, cortisol, hGH, IgEII, insulin, PAP, CK-MB, myoglobin, troponin I 2nd gen., ferritin, folate, B12, testosterone, CA 19-9, intact PTH, RBC folate, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D, HCG, SHBG, hsE2

Tests not available in U.S. but submitted for clearance EliA PR3s, GBM, MPOs, tryptase, dsDNA, Symphony ANA screen, 7 individual ENAs, Celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG/IgA, β2-glycoprotein IgM/IgG/IgA

EliA PR3s, GBM, MPOs, tryptase, EliA autoimmune products currently include CCP, dsDNA, symphony ANA screen, 7 individual ENAs, celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG/IgA, β2-glycoprotein IgM/IgG/IgA, EliA anti-TPO, EliA anti-TG

Tg

Tests not available in U.S. but available in other countries EliA CTD screen (15 ENAs), Pm/Scl, EliA anti IgA, EliA calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other “rare” ENAs, RF IgG, and CCP IgA

EliA CTD screen (15 ENAs), Pm/Scl, EliA Anti IgA, EliA calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other “rare” ENAs, RF IgG, and CCP IgA

BNP, HBsAg, HBsAb, HBcAg, HBcAb, HBeAg, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA, wPTH, D-dimer, osteocalcin, PIVKA, SCC, TPAb, ANP, KL-6

Tests in development — — presepsinTests not available on other manufacturers’ analyzers ImmunoCAP-specific IgE blood tests and EliA autoimmune

assaysImmunoCAP-specific IgE blood tests and EliA autoimmune assays

—

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —Methods supported/Separation methods fluoroenzyme immunoassay/ImmunoCAP cellulose polymer

matrix reaction wellsfluorescence/coated microwell, fluoroenzyme immunoassay, ImmunoCAP cellulose polymer matrix reaction wells

fluorescence, enzyme immunoassay/bead

Number of different measured assays onboard simultaneously up to 8 up to 8 48Number of different assays programmed, calibrated at once not limited, though inventory manager software will instruct

operator of reagent insufficiencies in the onboard inventorynot limited, though inventory manager software will instruct operator of reagent insufficiencies in the onboard inventory

48

Number of user-definable (open) channels 0 (closed system) 0 (closed system) 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

8/400, 100, or 50, depending on the conjugate type 8/400, 100, or 50, depending on the conjugate type 48/unitized test cup

Shortest/Median onboard reagent stability/Refrigerated onboard 5 days/1 year/yes (2°–8°C) 5 days/1 year/yes (2°–8°C) 72 hours/72 hours/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/product name, lot number, expiration date yes/product name, lot number, expiration date yes/lot number, test code, serial numberSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero (disposable sample tips) no/zero (disposable sample tips) no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 470/800 simultaneously (370 tests)/6,400 tests 470/800 simultaneously (370 tests)/9,200 tests 172/200/960System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/dryUses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency — — no/—Minimum specimen volume required 40 µL for ImmunoCAP tests and 20 µL for EliA tests 40 µL for ImmunoCAP tests and 50 µL for EliA tests 500 µL tube, 100 µL cupMinimum sample volume aspirated precisely at once/Minimum dead volume 40–200 µL for ImmunoCAP tests and 50 µL/

50–200 µL for EliA tests (varies with tube type)40–200 µL for ImmunoCAP tests and 50 µL/50–200 µL for EliA tests (varies with tube type)

10 µL/500 µL tube, 100 µL cup

Supplied with UPS (backup power)/Requires floor drain yes/yes yes/yes yes/noRequires dedicated water system/Water consumption yes/121 L yes/215 L no/—Noise generated 64 decibels 64 decibels —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–17 mm × 50–105 mm/no yes/10–17 mm × 50–105 mm/no yes/7 mL and 10 mL or 15 × 75 and 100, 13 × 75 and 100/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A no no yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun 100 minutes 100 minutes variesAutocalibration or autocalibration alert yes yes noNumber of calibrators required for each analyte 5 or 6 per analyte for calibration run (assay dependent), 2 per

analyte when using stored curve5 or 6 per analyte for calibration run (assay dependent), 2 per analyte when using stored curve

2 or 6 (analyte dependent)

Calibrants can be stored onboard/Average calibration frequency yes/28 days or sooner if conjugate lots change yes/28 days or sooner if conjugate lots change no/90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required once per work shift (user defined) once per work shift (user defined) 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/30 minutes unattended yes/yes/30 minutes no/no/5 minutes

Stat time to completion of βhCG test — — ~18 minutesTime delay from ordering stat test to aspiration of sample — — 40 secondsThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

160 specimens/480 (100 minutes to first result, then 8 results per 15 seconds )

320 specimens/960 (100 minutes to first result, then 8 results per 15 seconds )

66/200 (18 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/— onboard/— —/noLIS interfaces up and running in active user sites Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem,

American Health Net, Antrim, HL7, othersMisys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, HL7, others

—

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes yes yes (Hitachi, A&T, Bayer, Thermo, iLAS)Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <24 hours <24 hours 24 hoursMean time between failures/To repair failures — — 5 months/24 hoursAverage time to complete maintenance by lab personnel daily: 1 minute; weekly: 10 minutes; monthly: 15 minutes daily: 1 minute; weekly: 10 minutes; monthly: 15 minutes daily: 5 minutes; weekly: 5 minutesOnboard maintenance records/Maintenance training demo module yes/— yes/— yes (includes audit trail)/no

List price/Targeted bed size or daily volume —/>200,000 tests per year —/>400,000 tests per year $202,000/65+ beds, 1,500–2,000 testsAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 4 days on site/yes —/yes 4 days at company office/no



continuous random access analyzer provides more than 6,000 tests in one run; high-throughput instrument optimized for cost-conscious laboratories; efficient and flexible to meet allergy and autoimmune assay testing needs

continuous random access analyzer provides more than 9,000 tests in 1 run; high throughput; efficient and flexible to meet allergy and autoimmune assay testing needs

available in 2 models: standard and LA; unitized test cups similar to all AIA systems; 3 separate incubators to minimize processing time; no reagent preparation; dual clot detection, automated sample dilution, and pretreatment; appropriate for stat and routine use; biotin-free immunoassays

JUNE 2017 page 60




Part 21 of 21 TOSOH Bioscience TOSOH Bioscience Wako DiagnosticsSusan Kolarik [email protected] Susan Kolarik [email protected] [email protected]


6000 Shoreline Ct., Ste. 101, South San Francisco, CA 94080 6000 Shoreline Ct., Ste. 101, South San Francisco, CA 94080 1025 Terra Bella Ave., Ste. A, Mountain View, CA 94043800-248-6764 www.tosoh.com 800-248-6764 www.tosoh.com 877-714-1924 www.wakodiagnostics.com

Name of instrument/First year sold/Where designed AIA-360/2004/Japan AIA-900 (4 models)/2011/Japan µTASWako i30/2011/U.S., JapanCountry where manufactured/Where reagents manufactured Japan/Japan Japan/Japan Japan/JapanNumber of units in clinical use in U.S./Outside U.S. 2,000/6,500 350/1,300 >10/>300Operational type/Model type/Sample handling system continuous random access/benchtop/carousel continuous random access/3 floor standing; 1 benchtop/rack random access/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 21 × 19 × 16/2.1 35.04, 50.79, or 58.64 × 26.18 × 49.09; 30 × 40 ×

26.18/6–1021.5 × 20.5 × 23.4/3.34

Tests available on instrument in U.S. 10 minutes short-time assays: TSH, FT4, T3, T4, T-uptake, FT3, βhCG, estradiol, FSH, LH, progesterone, prolactin, AFP, CEA, PSA, CA 125, 27.29, β-2-microglobulin, C-peptide, cortisol, hGH, IgE II, insulin, PAP, CK-MB, myoglobin, troponin I second generation, ferritin, testosterone, CA 19-9, intact PTH, cystatin C, HbA1c, ACTH, DHEA-S, homocysteine, HCG, SHBG

TSH, 3rd-gen. TSH, T4, TT3, TU, FT4, FT3, TPOAb, TgAb, BHCG, estradiol, FSH, LHII, progesterone, prolactin, testosterone, AFP, CEA, PSA, CA 125, CA 19-9, 27.29, β2 microglobulin, C-peptide, insulin, IgEII, PAP, cortisol, HGH, B12, folate, RBC folate, ferritin, intact PTH, CK-MB, myoglobin, cTnI second generation, HbA1c, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D, SHBG, HCG, hsE2

AFP-L3 (AFP-L3% with total AFP), DCP (PIVKA-II)

Tests not available in U.S. but submitted for clearance Tg Tg —

Tests not available in U.S. but available in other countries BNP, HBsAg, HBsAb, HBcAg, HBcAb, HBeAg, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA, wPTH, PIVKA, D-dimer, osteocalcin, SCC, ANP, KL-6

BNP, HBsAg, HBsAb, HBcAb, HBeAb, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA, D-dimer, wPTH, osteocalcin, PIVKA, SCC, TPAb, ANP, KL-6

PCT, NT-proBNP, troponin-T

Tests in development presepsin presepsin —

Tests not available on other manufacturers’ analyzers — — AFP-L3, DCP


Methods supported/Separation methods fluorescence, enzyme immunoassay/bead fluorescence, enzyme immunoassay/bead fluorescence/capillary electrophoresisNumber of different measured assays onboard simultaneously 25 45 6Number of different assays programmed, calibrated at once entire menu entire menu 6

Number of user-definable (open) channels 0 — 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

—/unitized test cup unitized test cup/unitized test cup 6/100

Shortest/Median onboard reagent stability/Refrigerated onboard 72 hours/72 hours/— 72 hours/3 days/no 720 hours/—/yes (2°–10°C)Multiple reagent configurations supported yes no noReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/lot number, test code yes/test, lot no/RFID: lot number, expiration date, remaining tests, moreSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero no/zero (disposable tips) no/0.1 ppmWalkaway capacity in minutes/Specimens/Tests, assays 58/25/25 30/45/45 192/50/80System is open (homebrew methods can be used)/Liquid or dry system no/dry no/dry no/liquidUses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— —Minimum specimen volume required 500 µL tube, 100 µL cup 10 µL 0.2 mLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/500 µL tube, 100 µL cup 10 µL/100 µL 3 µL/75 µLSupplied with UPS (backup power)/Requires floor drain no/no yes/no no/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/primary draw tubes: 13 × 75 and 100; 16 × 75 and 100/no yes/13 × 75, 100; 16 × 75, 100/no yes/5, 7, 10 mL/noSample barcode reading capability/Autodiscrimination yes/yes yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes — —Onboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/no yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability no/no yes/yes no/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no yes/no no/no

Time between initial result and reaspiration of sample for rerun — 20 minutes —Autocalibration or autocalibration alert no no yesNumber of calibrators required for each analyte 2 or 6 (analyte dependent) 2 or 6 2–3, assay dependentCalibrants can be stored onboard/Average calibration frequency no/90 days no/90 days no/1× per kitMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes no/yesHow often QC required 24 hours 24 hours once a day or according to laboratory policyOnboard real-time QC/Support multiple QC lot Nos. per analyte no/no no/yes no/yesAutomatic shutdown/Startup is programmable/Startup time no/no/5 minutes no/no/10 minutes no/no/2 minutes

Stat time to completion of βhCG test ~18 minutes ~18 minutes —Time delay from ordering stat test to aspiration of sample 60 seconds 1 minute —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

12/36 (1 minute) 30/90 (0.67-minute sample cycle) 12 (assay dependent)/24 (140 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/no yes/no yes/yesData-management capability/Instrument vendor supplies LIS interface —/no no/no onboard/—LIS interfaces up and running in active user sites — all major LIS suppliers —

LIS interface operates simultaneously with running assays yes yes —Bidirectional interface capability no yes (broadcast download and host query) yes (host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no no/no/no no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — 24 hours based on contractMean time between failures/To repair failures >6 months/24 hours — —Average time to complete maintenance by lab personnel daily: 5 minutes daily: 5 minutes; weekly: 15 minutes; monthly: 20 minutes monthly: 15 minutesOnboard maintenance records/Maintenance training demo module no/no no/no no/no

List price/Targeted bed size or daily volume $31,000/200–1,000 tests per month $89,000 base model/500+ monthly —Annual service contract cost (24 hours/7 days) $2,050–$3,500 $6,000 base model —Training provided with purchase/Advanced operator training training DVD; on-site install/— —/no —



unitized test cups; primary tube sampling; no reagent preparation, room-temperature stability for 5 days; third-generation TSH sensitivity; second-generation troponin I; appropriate for stat and routine use; compact size; 4 tests per sample; random access; biotin-free immunoassays

4 models (base model, base model plus 9-tray sorter, base model plus 19-tray sorter, benchtop) offer increasing automation and capacity; connections and software built in for all 4 models; unitized test cups, no reagent preparation; automated sample dilution, pretreatment, automated reschedule, retest; biotin-free immunoassays

microfluidics technology, small footprint, tabletop, liver cancer markers; small sample volume; fast turnaround time

june 2017 page 38 - cap today

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