itc - point-of-care testing · • since 1966, when itc developed the activated clotting time test,...

ITC Point of Care Testing Products

• Coagulation testing products

• Oximetry and Co-Oximetry testing products

• Blood Gas/Lytes/Metabolites testing products

• Incision products for capillary blood sampling

Coagulation Testing Products


• Since 1966, when ITC developed the Activated Clotting Time test, we have been the world leader in POC tests for ACT.

• Since then, we have also developed tests for aPTT, PT/INR, HiTT, HRT, PRT and PDAO.

• Today, ITC remains the only company in the world with a testing menu this extensive for POC coag testing.


• Our first product, ACT celite, was initially developed for use with a 2 ml sample of fresh whole blood, and a test tube containing a celite activator.

• This test is still manufactured, and is still the gold standard against which all others are compared.

• It is currently the methodology used in our Hemochron Response analyzer.


• The Hemochron Response is still in use in hundreds of hospitals throughout the world today. Still considered a durable, reliable and accurate product, with great economic value.

• In light of the questions and concerns relative to the “new” or reformulated heparin that is now in circulation, renewed interest has developed for the RxDx program of Heparin and Protamine dosing available on the Response.

Coagulation Testing Products• RxDx is ITC’s trade name for our Heparin/Protamine dosing

protocol available only on the Hemochron Response. Obviously, this program is used only during Open Heart Procedures.

• It consists of a software program internal to the Response, that takes the operator through several questions, and requires the use of some additional tests.

• The operator must input the patient’s height, weight and sex, and then the program estimates the patient’s circulating blood volume. The operator is also prompted to enter the “target” ACT time for the procedure (typically 480 seconds).


• At that point, the operator is instructed to process a baseline ACT test, as well as a Heparin Response Test (HRT). The heparin response test determines that particular patient’s response to heparin.

• Based on the patient’s response to heparin, the circulating blood volume that is calculated, and the target ACT time, and the baseline ACT that was just processed, the RxDx program recommends a heparin dose that will get the patient to the targeted ACT time.


• Once the recommended heparin dose is given, a subsequent ACT is processed to insure that the heparin had the planned effect and the ACT is at, or above the target time. If not, an additional heparin dose is recommended and process begins again.

• Once the case is over, and it is time to reverse the heparin with protamine, the operator is prompted to run an ACT, and a Protamine Response Test (PRT) to determine the patient’s response to protamine.

Coagulation Testing Products• Once the ACT and the PRT are processed, and the circulating

heparin level is calculated, the RxDx program recommends a dose of protamine required to reverse the heparin on board the patient.

• Once the heparin is reversed, a Protamine Dose Assay (PDAO) is processed to document the reversal of the heparin. Some operators simply use an additional ACT test to confirm protamine reversal, and don’t process the PDAO.

• The idea behind the RxDx software and tests is to assist the surgical team in reducing bleeding complications post-op and reducing the amount of blood products given during the case, such as FFP, and AT-3.

Pre-Operative Intra-Operative Post-Operative


• Although the Hemochron Response was considered the gold standard, ITC felt there was still room for improvement. The Response tube methodology, although trusted by many, is reliant on the operator for adding the correct sample size (2ml), and following a relatively complex sequence for processing a test. Differences in sample size, how vigorously the operator shakes the tube, when the “start” button is depressed, etc, all affect the result of the test.


• Additionally, hypothermia, and hemodilution, two absolute side effects of open heart surgery, effect the ACT result as reported by the Hemochron Response tube and all competitors.

• Based on these recognized needs, ITC developed the first micro-sample ACT test. It is processed on the Hemochron Signature Elite.


• Instead of a test tube requiring 2ml of fresh whole blood, the Elite utilizes a cuvette that requires only 15 ul of patient sample.


• The dramatic reduction in sample size was welcomed by the pediatric cardiac surgery community, and the cath labs that treat pediatric patients.

• A tremendous unexpected outcome of the development of this technology was that it is not affected by the hemodilution and hypothermia that affects all the other tests on the market, including the Response tube method.

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• There are 2 ACT tests available on the Elite.– ACT-LR– ACT+


• Our ACT tests are indicated for the monitoring of anti-coagulant effect of heparin in the following concentrations:

• ACT-LR: 0.0 to 2.0 units of heparin/ml blood• ACT+: 1.0 to 6.0 units of heparin/ml blood• The linearity range of the cuvettes is as

follows:• ACT-LR: 67-400 seconds• ACT+: 67-1005 seconds


• These tests are primarily used in the following areas:

• ACT-LR: Cath Lab, Radiology, Dialysis, ECMO, general surgery/vascular surgery.

• ACT+: Cardiac Surgery and EP Lab• The differences are due to the amount of

heparin given in each procedure.


• ITC and Medtronic have the only ACT tests on the market indicated for monitoring low levels of heparin, which is what is seen in ECMO, LVAD patients, dialysis, certain surgical procedures, and when the cath lab staff is preparing to pull the arterial introducer sheath after the procedure.

• This information is taken directly from all of the vendor’s package inserts. Available upon request.


• Additional tests available on this platform:– aPTT

• For either fresh whole blood or citrated samples

– PT/INR• For either fresh whole blood or citrated samples


• Compliance Technology– The Signature Elite provides everything that is

required to insure that all testing is done in compliance with various regulatory agencies requirements.


• Automated daily electronic QC• QC Lockout

– For both daily electronic, and monthly liquid QC• Patient ID

– Either manual entry or via bar code• Operator ID

– Either manual entry or via bar code


• Cuvette lot number scanning• QC result range scan in• Last test recall• Up to 600 patient recall internal to instrument• Up to 600 QC test recall internal to instru• ment• Supervisor lock out prevents any changes

Oximetry/Co-Oximetry Products

• Avox 1000E:– Provides results for Total Hb and O2 Saturation– Provides a fractional measurement of O2 Sat.– Our main competitor provides a functional O2sat.– The difference is due to the number of other Hb

fractions measured. We measure with 5 wavelengths and account for Carboxy, Meth, and reduced Hb.

– Our competitor measures with 2 wavelengths.


• Avox 1000E compliance features– Operator ID lockout– Patient ID lockout– QC lockout, both Optical and Liquid


• Avox 4000 Co-Oximeter– Measures O2 Content, Total Hb, Carboxy, Meth– Utilizes 7 wavelengths for measurement– Has the same features as the 1000E in compliance

related areas.

Blood Gas/Lytes Products

• IRMA TruPoint– Cartridge based ABG and electrolyte analyzer– Also measures Glu, Creatinine, BUN and Lactate– Various measurement cartridges– Room temp storage for ABG and Lytes– Refrigerated storage for Lactate and Creatinine

Blood Gas/Lytes Products

• Critical features of the IRMA Trupoint– Auto Daily EQC– Battery operated or AC power capable– Liquid QC required weekly, bi-level– Bar code scanner optional– All lockouts available– The only POC ABG analyzer that provides for correlation

correction of every analyte.– Ability to permit offline Hb value to be substituted for the

Hct measurement if requested

itc - point-of-care testing · • since 1966, when itc developed the activated clotting time test,...

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