cal cont enz sub p400 en

CO2 CalABX Pentra

Form

-084

9 R

ev. 2

ABX Pentra CO2 CalRef.: A11A01648Volume: 3 x 3 ml

2006/04/10A93A00702C EN

A11A01648

3 x 3 ml

Calibrator for the measurement of bicarbonate / total CO2.

HORIBA ABXBP 729034184 Montpellier - cedex 4 - France

Intended useABX Pentra CO2 Cal is used to calibrate ABX Pentra CO2 RTU, Ref.A11A01645.

Characteristics• ABX Pentra CO2 Cal is a calibrator solution containing 30 mmol/l of

bicarbonate.• ABX Pentra CO2 Cal is ready-to-use.• ABX Pentra CO2 Cal should be used according to this calibrator notice.

HORIBA ABX cannot guarantee its performance if used otherwise.

HandlingRemove the cap of the vial, transfer the calibrator in a sample cup andplace in the correct position on the ABX Pentra 400 or on the Mira.

Materials required but not provided• Automated clinical chemistry analyser.• Standard laboratory equipment.

Assigned valuesThe assigned values are determined with a reference material inaccordance with an established protocol (traceable to gravimetricprocedure).Please refer to the vial label for the exact concentration.

Storage and StabilityCalibrators, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-25 °C and protected from light.Once opened, ABX Pentra CO2 Cal is stable for 3 months if recappedimmediately after use and stored at 2-8°C.Do not freeze.

Waste ManagementPlease refer to local legal requirements.

General Precautions1. ABX Pentra CO2 Cal should be used only for the determination of

the calibration curve.2. This calibrator is for professional in-vitro diagnostic use only.3. The calibrator vials should be discarded after use.4. Please refer to the MSDS associated with the calibrator.

WarningIt is the user’s responsibility to verify that this document is applicableto the calibrator used.

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE
332 B Latest version documents on www.horiba-abx.com

CO2 CalABX Pentra

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com

Fructo CalABX Pentra

Form

-084

9 R

ev. 2

ABX Pentra Fructo CalRef.: A11A01680Volume: 3 x 1 ml

2006/04/10A93A00812C EN

A11A01680

3 x 1 ml

Calibrator for the determination of Fructosamine by colorimetry.


Intended useABX Pentra Fructo Cal is used for the determination of the calibrationcurve of ABX Pentra Fructosamine, Ref. A11A01679.

Characteristics• ABX Pentra Fructo Cal is a calibrator obtained from human serum.

The concentration of fructosamine is found in an easily measuredzone.

• ABX Pentra Fructo Cal is lyophilised.• ABX Pentra Fructo Cal should be used according to this calibrator

notice. HORIBA ABX cannot guarantee its performance if usedotherwise.

Handling1. Reconstitute the contents of one vial with exactly 1.0 ml of

distilled water.Carefully open the vial, taking care not to spill lyophilisate.

2. Recap the vial with care, and dissolve the contents by successivelyinverting the vial.

3. Allow the solution to rest for at least 60 minutes before use.4. Use a pipette to transfer the required volume into a sample cup

and place it in the correct position on the ABX Pentra 400 or onthe Mira.

Materials required but not provided• Automated clinical chemistry analyser.• Standard laboratory equipment.• Distilled water.

Assigned valuesThe calibration value has been determined under strictly standardisedconditions, using the specified method. The values have beenobtained in external laboratories, and the specified calibration valuecorresponds to the mean value of the levels obtained in at least sevenlaboratories and at least three independent test series.

The fructosamine concentration is lot-specific. The theoretical valuesare indicated in the enclosed annex, Ref. 04710792.

Storage and StabilityUnopened calibrators are stable up to the expiry date stated on thelabel if stored at 2-8 °C.

Following reconstitution, ABX Pentra Fructo Cal is stable for:

7 days at 15-25° C28 days at 2-8° C



General Precautions1. Calibrator, for professional in-vitro diagnostic use only.2. Follow proper laboratory handling precautions.3. This product has been prepared exclusively with blood proceeding

from donors who were tested negative for the HBs antigen and HIV1, HIV 2 and HCV antibodies. Since the absence of an infection riskcannot be completely assured, this product should be handled withthe same caution that is applied to patient samples. In case ofexposure, follow local health authority regulations (2,3).

4. The calibrator vials should be discarded after use.5. Please refer to the MSDS associated with the calibrator.

WarningIt is the user's responsibility to verify that this document is applicableto the calibrator used.

Reference1. Schleicher ED, Vogt BW. Standardization of serum fructosamine

assays. Clin Chem 1990 ; 36 : 136-139.2. Occupational Safety and Health Standards : bloodborne pathogens.

(29 CFR 1910. 1030). Federal register. July 1, 1998 ; 6 :267-2803. Directive du Conseil de l’Europe (90/679/CEE). Journal Officiel de

la Communauté Européenne n°L374 du 31.12.1990, p. 1-12.


Fructo CalABX Pentra


HDL CalABX Pentra

Form

-084

9 R

ev. 2

ABX Pentra HDL CalRef.: A11A01647Volume: 2 x 1 ml

2006/04/10A93A00682C EN

A11A01647

2 x 1 ml

Calibrator for the measurement of High-Density Lipoprotein Cholesterol (HDL-C) by colorimetry.


Intended useABX Pentra HDL Cal is used to determine the calibration curve of ABXPentra HDL Direct CP, Ref. A11A01636.

Characteristics• ABX Pentra HDL Cal is lyophilized. It is composed of two vials of

1ml. It is a preparation of lyophilized human serum containinglipoproteins from the various lipoprotein classes including high-density lipoproteins.

Note: The HDL cholesterol value is traceable to the Center for DiseaseControl (CDC) described reference method for determination of HDLcholesterol.

• ABX Pentra HDL Cal should be used according to this calibratornotice. HORIBA ABX cannot guarantee its performance if usedotherwise.

Handling1. Reconstitute the contents of one vials with 1.0 ml of distilled or

deionized water.Be careful when opening the rubber caps as some lyophilizedmaterial may be lost.

2. Close the vial and let stand for 20 minutes. 3. Dissolve the contents of the vial by inverting it gently to avoid the

formation of foam. Do not shake.4. Use a pipette to transfer the required volume into a sample cup

and place it on the appropriate rack of the ABX Pentra 400 or Mira.


Assigned valuesThe value of ABX Pentra HDL Cal is assigned by procedures traceable tothe National Reference System for Cholesterol (NRS/CHOL). Calibrationmaterials have concentrations around the medical decision level.The assigned values are indicated in the enclosed annex, Ref.04710800.

Storage and StabilityCalibrators, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-8 °C and protected from light.Once reconstituted, ABX Pentra HDL Cal is stable for 14 days at 2-8 °C.Reconstitution stability of the calibrator may be extended byaliquoting and freezing the reconstituted calibrator preparation at lessthan -70 °C for up to 4 weeks.


Waste Management1. Please refer to local legal requirements.2. This calibrator contains less than 0.1 % of sodium azide as a

preservative. As sodium azide may react with lead and copper toform explosive metal azides, this calibrator should be disposed ofby flushing with copious amounts of water.

General Precautions1. ABX Pentra HDL Cal should be used only for the determination of

the calibration curve.2. This calibrator is for professional in-vitro diagnostic use only.3. Do not pipette by mouth.4. Warning: Human source material. Treat as potentially infectious.

Each plasma donor unit used in the preparation of this product hasbeen tested by an FDA-approved method and found nonreactive forthe presence of HBsAg, HCV, and antibody to HIV 1/2. Because noknown test method can offer complete assurance that hepatitis Bvirus, Human Immunodeficiency Virus (HIV) or other infectiousagents are absent, the calibrators should be treated like patientspecimens as potentially infectious and handled with appropriatecautions in accordance with good laboratory practices.




HDL CalABX Pentra


LDL CalABX Pentra

Form

-084

9 R

ev. 2

ABX Pentra LDL CalRef.: A11A01678Volume: 2 x 1 ml

2006/04/10A93A00692C EN

A11A01678

2 x 1 ml

Calibrator for the measurement of Low Density Lipoprotein Cholesterol (LDL-C).


Intended useABX Pentra LDL Cal is used to determine the calibration curve of ABXPentra LDL Direct CP, Ref. A11A01638.

Characteristics• ABX Pentra LDL Cal is lyophilized. It is composed of two vials of

1ml. It is a preparation of lyophilized human serum containinglipoproteins from the various lipoprotein classes including low-density lipoproteins.

Note: The LDL cholesterol value is traceable to the Reference Method(Ultracentrifugation) for the determination of LDL Cholesterol.

• ABX Pentra LDL Cal should be used according to this calibratornotice. HORIBA ABX cannot guarantee its performance if usedotherwise.

Handling1. Reconstitute the contents of one vial with 1.0 ml of distilled or

deionized water.Be careful when opening the rubber cap as some lyophilizedmaterial may be lost.

2. Close the vial and let stand for 5 minutes.3. Dissolve the contents of the vial by agitate it slowly, avoiding the

formation of foam. Do not shake.4. Use a pipette to transfer the required volume into a sample cup

and place it on the appropriate rack of the ABX Pentra 400 or Mira.


Assigned valuesThe value of ABX Pentra LDL Cal is assigned by procedures traceableto the National Reference System for Cholesterol (NRS/Chol).Calibration materials have concentrations around the medical decisionlevel.The assigned values are indicated in the enclosed annex, Ref.04710801.

Storage and StabilityCalibrators, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-8 °C and protected from light.Once reconstituted, ABX Pentra LDL Cal is stable for 2 weeks at 2-8°C.The reconstituted calibrator may be aliquoted and stored at -80°C.




General Precautions1. ABX Pentra LDL Cal should be used only for the determination of

the calibration curve.2. This calibrator is for professional in-vitro diagnostic use only.3. Warning: Human source material. Treat as potentially infectious.

Each plasma donor unit used in the preparation of this producthave been tested by an FDA approved method and found non-reactive for the presence of HBsAg, HCV and antibody to HIV1/2.Because no known test method can offer complete assurance thathepatitis B virus, Human Immunodeficiency Virus (HIV) or otherinfectious agents are absent, the calibrators should be treated likepatient specimens as potentially infectious and handled withappropriate cautions in accordance with good laboratory practices.




LDL CalABX Pentra


MultiCalABX Pentra

Form

-084

9 R

ev. 3

ABX Pentra MultiCalRef.: A11A01652Volume: 10 x 3 ml

2009/10/05A93A00672E EN

A11A01652

10 x 3 ml

Calibrator for the measurement of substrates and enzymes by colorimetry.

HORIBA ABX SASBP 729034184 Montpellier - cedex 4 - France

Intended useABX Pentra MultiCal is used to calibrate substrates and enzymesassays on clinical chemistry analysers.

Characteristics• ABX Pentra MultiCal is lyophilized.

The concentrations and activities have been adjusted to ensureoptimum calibration of automatic analysers.

• The origin of the biological additives is as follows:

• Reactive components: Human serum with chemical additives andtissue extracts of human and animal origin.

• Non-Reactive components: Stabilizers.

The concentrations/activities of the components are lot-specific. Theexact calibration values are listed in the enclosed annex, Ref04710797.

• ABX Pentra MultiCal should be used according to this calibratornotice. The manufacturer cannot guarantee its performance if usedotherwise.

Handling1. Reconstitute the contents of one calibrator vial with 3ml of

distilled/deionised water.

The kit is composed of 10 vials of calibrator (lyophilizate for 3 ml)

ALT (GPT) Porcine heartAST (GOT) Porcine heartAlbumin Bovine plasmaAldolase Rabbit muscleAlkaline phosphatase Placenta (human, recombinant)Amylase (total) Porcine pancreasAmylase (pancreatic) Porcine pancreasCholesterol Bovine plasmaCholinesterase Human serumCreatine kinase Rabbit muscleγ -GT Porcine kidneyGLDH Bovine liverLD (LDH) Porcine heartLipase Human pancreas (recombinant)Acid phosphatase Human prostate / PotatoTriglycerides Chicken egg yolk


Be careful when opening the rubber cap as some lyophilizedmaterial may be lost.

2. Close the vial carefully and dissolve the contents within 30minutes by turning the vial upside down, making sure that no foamis produced.

3. Use a pipette to transfer the required volume into a sample cupand place it on the appropriate rack of the ABX Pentra 400 or Mira.

Materials required but not provided• Automated clinical chemistry analyser.• Standard laboratory equipment.• Distilled or deionised water.

Assigned valuesa

The calibrator values were determined using the method mentioned inthe enclosed annex.

Determinations were performed under strictly standardized conditionson HORIBA Medical analyzers using HORIBA Medical reagents andHORIBA Medical master calibrator.

The calibration values were obtained via multiple assays performed indifferent analysers in several independent series. The calibration valuespecified is the median of the values obtained.

Assigned values are indicated in the enclosed annex, Ref. 04710797.Traceability of the assigned values are given in the tables below.

a. Modification from index D to E: modification of Assigned values.

332 B Latest version documents on www.horiba.com

MultiCalABX Pentra

List of parameters standardized by the calibrator comparison method:

List of parameters standardized by comparison of methods with“pools” of human serum:

Storage and StabilityCalibrators, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-8 °C.

Stability of components* after the reconstitution of ABX PentraMultiCal:

*Exceptions : see below.

Stability of direct bilirubin after reconstitution (when stored protectedfrom light):

Stability of total bilirubin after reconstitution (when stored protectedfrom light):

Store calibrators tightly capped when not in use.


General Precautions1. This calibrator is for professional in-vitro diagnostic use only.2. Observe the standard laboratory precaution for use.3. All products derived from blood are prepared exclusively from the

blood of donors tested individually and shown by FDA-approvedmethods to be free from HBsAg and antibodies to HCV and HIV.However, as no testing method can rule out the potential risk ofinfection with absolute certainty, the material should be treatedjust as carefully as patient specimen, as potentially infectious andhandled with appropriate caution. In case of exposure, follow theguidelines of the competent health authorities (1,2).



Reference1. Department of Labor, Occupational Safety and Health Standards:

bloodborne pathogens. (29 CFR Part 1910.1030). Federal RegisterJuly 1, 1998; 6: 267-280.

2. Council Directive (90/679/EEC). Official Journal of the EuropeanCommunities. No. L374 from December 31, 1990: 1-12.

Parameter Reference materialALT ERM-AD454Albumin ERM-DA470Amylase IRMM/IFCC-456Total Bilirubin SRM916aTotal Protein SRM927/VERICHEM 9460Calcium SRM909bCholesterol SRM909bCK-NAC ERM-AD455Creatinine SRM967GGT ERM-AD452Glucose PAP SRM965aGlucose HK SRM965aIron SRM937LDH ifcc ERM-AD453Magnesium SRM909bUrea / BUN SRM909bUric Acid SRM913aTriglycerides SRM909b

Parameter Reference methodALP IFCC Reference Measurement Procedure (37°C) for

ALPAST IFCC Reference Measurement Procedure (37°C) for

ASTDirect Bilirubin Primary reference material (weighed in purified

material) Bilirubin ditaurateLactate Primary reference material (weighed in purified

material)LDH HORIBA Medical Reagent/manual measurement;

Epsilon of NADHLipase HORIBA Medical Reagent/manual measurement;

Epsilon of methylresorufinPhosphorus Primary reference material (weighed in purified

material) NERL

8 hours at 15°C to 25°C2 days at 2°C to 8°C2 weeks at -25°C to -15°C (only one freezing session)

3 hours at 15°C to 25°C8 hours at 2°C to 8°C2 weeks at -25°C to -15°C (only one freezing session)

6 hours at 15°C to 25°C1 day at 2°C to 8°C2 weeks at -25°C to -15°C (only one freezing session)

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba.com

TPU Cal

ABX Pentra

Form

-084

9 R

ev. 3

ABX Pentra TPU CalRef.: A11A01898Volume: 3 x 3 ml

2009/04/02A93A01220A EN

A11A01898

3 x 3 ml

Calibrator for the quantitative in vitro determination of urinary proteins by colorimetry.

HORIBA ABX SASBP 729034184 Montpellier - cedex 4 - France

Intended useABX Pentra TPU Cal is used to calibrate ABX Pentra Urinary ProteinsCP, Ref. A11A01642.

Characteristics• ABX Pentra TPU Cal is a liquid ready-to-use calibrator based on a

aqueous solution containing human serum.

The kit is composed of 3 vials of 3 ml.

• ABX Pentra TPU Cal should be used according to this calibratornotice and as specified in the respective instructions for use of thereagent. The manufacturer cannot guarantee its performance if usedotherwise.

HandlingABX Pentra TPU Cal is ready-to-use.Mix carrefully before use. Avoid the formation of foam.Remove the cap of the vial, transfer the calibrator in a sample cup andplace in the correct position on the ABX Pentra 400.

Materials required but not provided• HORIBA Medical reagents and automated clinical chemistry analyser.• Standard laboratory equipment.

Assigned valuesThe calibrator value is traceable with SRM927.Please refer to the vial label for the exact concentration.

Storage and StabilityCalibrators, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-8 °C.Stability after opening: 9 weeks at 2-8°C.Store calibrator tightly capped when not in use.




General Precautions1. This calibrator is for professional in-vitro diagnostic use only.2. Observe the standard laboratory precaution for use.3. All human material should be considered as potentially infectious.

All products derived from blood are prepared exclusively from theblood of donors tested individually and shown by approvedmethods to be free from HBsAg and antibodies to HCV and HIV.However, as no testing method can rule out the potential risk ofinfection with absolute certainty, the material should be treatedjust as carefully as patient specimen, as potentially infectious andhandled with appropriate caution. In case of exposure, follow theguidelines of the competent health authorities (1,2).

4. The calibrator vials should be discarded after use. Disposal of allwaste material should be in accordance with local guidelines.

5. Please refer to the MSDS associated with the calibrator.




2. Council Directive (2000/54/EC). Official Journal of the EuropeanCommunities. No. L262 from October 17, 2000: 21-45.

332 B Latest version documents on www.horiba.com

TPU CalABX Pentra

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba.com

Urine Cal

ABX Pentra

Form

-084

9 R

ev. 2

ABX Pentra Urine CalRef.: A11A01673Volume: 3 x 1 ml

2005/10/18A93A01195A EN

A11A01673

3 x 1 ml

Calibrator for the measurement of urinary proteins by colorimetry.


Intended useABX Pentra Urine Cal is used to calibrate ABX Pentra UrinaryProteins CP, Ref. A11A01642.

Characteristics• ABX Pentra Urine Cal is a liquid ready-to-use calibrator based on a

buffered aqueous solution.

The concentrations of the calibrator components have been adjustedto ensure optimal calibration on clinical chemistry analysers.

- Reactive components:HEPES buffer: 20 mmol/l, Ph 7.5Chemical additives and material of biological origin as specified below:

- Non-reactive components:Preservatives and stabilizers.

• ABX Pentra Urine Cal should be used according to this calibrator notice.HORIBA ABX cannot guarantee its performance if used otherwise.

HandlingABX Pentra Urine Cal is ready-to-use.Mix carrefully before use. Avoid the formation of foam.Remove the cap of the vial, transfer the calibrator in a sample cup andplace in the correct position on the ABX Pentra 400 or on the Mira.


Assigned valuesThe calibrator values were obtained via single determinationsperformed in different laboratories in several independent series. Thecalibrator value specified is the median of all values obtained.The concentrations of the components are lot-specific and may varyfrom lot to lot. The exact calibration values are listed in the enclosedannex, Ref 04710799.

Analyte originAlbumin Human serumα1-Microglobulin Human urineImmunoglobulin G Human serumTotal protein Human serum/sheep serum


Storage and StabilityCalibrators, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-8 °C.Stability after opening: 4 weeks at 2-8 °C , provided that dispensingof the calibrator takes place without microbial contamination, e.g. bypouring out. Store calibrator tightly capped when not in use.

Waste Management1. Please refer to local legal requirements.

General Precautions1. This calibrator is for professional in-vitro diagnostic use only.2. Observe the standard laboratory precaution for use.3. All human material should be considered as potentially infectious.

All products derived from blood are prepared exclusively from theblood of donors tested individually and shown by FDA-approvedmethods to be free from HBsAg and antibodies to HCV and HIV.However, as no testing method can rule out the potential risk ofinfection with absolute certainty, the material should be treatedjust as carefully as patient specimen, as potentially infectious andhandled with appropriate caution. In the event of exposure, thedirectives of the responsible health authorities should be followed(1,2).

4. The calibrator vials should be discarded after use. Disposal of allwaste material should be in accordance with local guidelines.

5. Please refer to the MSDS associated with the calibrator.



Urine CalABX Pentra



2. Council Directive (2000/54/EC). Official Journal of the EuropeanCommunities. No. L262 from October 17, 2000: 21-45.


CK ControlABX Pentra

Form

-085

0 R

ev. 2

ABX Pentra CK ControlRef.: A11A01786Volume: 4 x 3 ml

2006/04/14A93A01152C EN

A11A01786

4 x 3 ml

Control serum for the measurement of CK-NAC and CK-MB.


Intended useABX Pentra CK Control is a control used to monitor the performancesof CK-NAC and CK-MB determination.

Characteristics• ABX Pentra CK Control is a lyophilized control based on bovine

serum albumin. The adjusted concentrations and activities of thecontrol components are usually in the normal range or at thenormal/pathological threshold.

Reactive components:Bovine serum albumin with chemical additives and material ofbiological origin as specified.

Origin of biological substances:

Non-reactive components:Preservatives and stabilizers.

• ABX Pentra CK Control should be used according to this control notice.HORIBA ABX cannot guarantee its performance if used otherwise.

Handling1. Reconstitute the content of one vial with 3.0ml of distilled/

deionized water.Be careful when opening the rubber cap as some lyophilisedmaterial may be lost.

2. Close the vial carefully and allow it to stand for 30 minutes, gentlyinvert the vial to facilitate the dissolution. Avoid foaming. Do notshake.


4. Once reconstituted, treat the control as a patient specimen.

The control should be run daily in parallel with the patient samples andafter every calibration. The control intervals should be adapted to eachlaboratory’s individual requirements. Each laboratory shouldestablished QC procedures that conform with pertinent regulations oraccreditation requirements.

Materials required but not provided• Automated clinical chemistry analyser• Standard laboratory equipment• Distilled or deionized water

Analyte OriginCK-MM humanCK-BB porcine brain


Assigned valuesAssigned values have been determined by calibration with a referencematerial in accordance with established protocols.Assigned values for the ABX Pentra CK Control vary from lot to lot.The control values are indicated in the enclosed annex, Ref. 04710805.

Storage and StabilityControls, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-8 °C .Once reconstituted, ABX Pentra CK Control can be used within theperiod reported below if stored tightly closed at the indicatedtemperature:


General Precautions1. This control is for professional in-vitro diagnostic use only.2. Follow proper laboratory handling precautions.3. All human material should be considered as potentially infectious.

This product has been prepared exclusively from blood proceedingfrom donors which has been analysed individually in accordancewith the FDA-approved method. No HBsAg and antibodies to HCVand HIV has been detected. However, since the absence of aninfection risk cannot be completely assured, this product should behandled with the same precautions that are applied to patientsamples. In case of exposure, follow local health authorityregulations (1,2).

4. The control vials should be discarded after use.5. Please refer to the MSDS associated with the control.

24 hours at 15-25 °C3 days at 2-8 °C4 weeks at -15/-25 °C (only one freezing session)


CK ControlABX Pentra

WarningIt is the user’s responsibility to verify that this document is applicableto the control used.

Reference1. Occupational Safety and Health Standards: bloodborne pathogens.

(29 CFR Part 1910.1030). Federal Register. July 1, 2001; 17:260-273.

2. Council Directive (2000/54/EC). Official Journal of the EuropeanCommunities No. L262 from October 17, 2000.


CO2 ControlABX Pentra

Form

-085

0 R

ev. 2

ABX Pentra CO2 ControlRef.: A11A01650Volume: 3 x 3 ml

2006/04/14A93A00852C EN

A11A01650

3 x 3 ml

Control for the measurement of Bicarbonate/Total CO2.


Intended useABX Pentra CO2 Control is a control used to monitor the performancesof Bicarbonate/Total CO2 determination.

Characteristics• ABX Pentra CO2 Control is liquid and ready-to-use.• ABX Pentra CO2 Control should be used according to this control notice.

HORIBA ABX cannot guarantee its performance if used otherwise.

HandlingRemove the cap of the vial, transfer the control in a sample cup andplace in the correct position on the ABX Pentra 400 or on the Mira.


Assigned valuesAssigned values have been determined by calibration with a referencematerial in accordance with established protocols.The assigned values are indicated in the enclosed annex, Ref. 04710802.

Storage and StabilityControls, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-25 °C and protected from light.Once opened, ABX Pentra CO2 Control is stable for 3 months, at2-8°C, if recapped immediately after use.Proper storage and handling of this product must be observed.


General Precautions1. This control is for professional in-vitro diagnostic use only.2. The control vials should be discarded after use.3. Please refer to the MSDS associated with the control.


Reference1. Röhle G., Siekmann L. Quality assurance of quantitative

determination. In: Thomas L., editor. Clinical laboratory diagnostics.1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 1393-1401.


CO2 ControlABX Pentra


Fructo Control NABX Pentra

Form

-085

0 R

ev. 2

ABX Pentra Fructo Control NRef.: A11A01681Volume: 3 x 1 ml

2006/04/14A93A00932C EN

A11A01681

3 x 1 ml

Control serum for the determination of fructosamine by colorimetry (normal level).


Intended useABX Pentra Fructo Control N is used to verify the accuracy andprecision of the fructosamine determination.

Characteristics• ABX Pentra Fructo Control N is a lyophilised control serum obtained

from human serum.• The fructosamine concentrations are lot-specific and are within the

normal range or at the normal range limit.• ABX Pentra Fructo Control N should be used according to this

control notice. HORIBA ABX cannot guarantee its performance ifused otherwise.



2. Mix well. Avoid the formation of foam.3. Allow the solution to rest for at least 60 minutes before use.4. Use a pipette to transfer the required volume into a sample cup

and place it on the appropriate rack of the ABX Pentra 400 or Mira.5. Once reconstituted, treat the control serum like a patient

specimen.

The frequency of controls should correspond to the guidelines of theindividual laboratory.

Materials required but not provided• Automated clinical chemistry analyser.• Standard laboratory equipment.• Bidistilled water.

Assigned valuesThe theoretical values and dispersion intervals have been obtained bysingle determinations performed in at least 7 laboratories and in atleast 3 independent series.Theoretical value = mean value of the measurements.Dispersion interval = theoretical value ± 3s (s: standard deviationfound by means of multiple determinations of theoretical values).

The reagents and analysers used for the determinations have been theones available at the time.

The results must be within the range of the defined confidence limits.If a tendency towards higher or lower values is observed, or if thevalues are even above the dispersion limits, it is necessary to verifyeach step of the measurement process.


Each laboratory should establish a procedure to follow if the resultsexceed the specified dispersion interval.

The theoretical values, along with the exact dispersion intervals, arespecified in the enclosed annex, Ref. 04710793.

Storage and StabilityUnopened controls are stable up to the expiry date stated on the label.Following reconstitution, the control serum is stable for:


General Precautions1. Control, for professional in-vitro diagnostic use only.2. Follow proper laboratory handling precautions.3. This product has been prepared exclusively from blood proceeding

from donors which has been analysed individually in accordancewith the FDA-approved method. No HBs antigen or HIV / HCVantibody has been detected. However, since the absence of aninfection risk cannot be completely assured, this product should behandled with the same precautions that are applied to patientsamples. In case of exposure, follow local health authorityregulations (1,2).


WarningIt is the user's responsibility to verify that this document is applicableto the control used.

1 week at 25 °C4 weeks at 2-8° C


Fructo Control NABX Pentra

Reference1. Occupational Safety and Health Standards : bloodborne pathogens.

(29 CFR 1910. 1030). Federal Register. July 1, 1998 ; 6 : 267-280.2. Council Directive (90/679/EEC). Official Journal of the European

Communities No. L374 from Dec. 31, 1990 : 1-12.


Fructo Control PABX Pentra

Form

-085

0 R

ev. 2

ABX Pentra Fructo Control PRef.: A11A01682Volume: 3 x 1 ml

2006/04/18A93A00942C EN

A11A01682

3 x 1 ml

Control serum for the determination of fructosamine by colorimetry (pathological level).


Intended useABX Pentra Fructo Control P is used to verify the accuracy andprecision of the fructosamine determination.

Characteristics• ABX Pentra Fructo Control P is a lyophilised control serum obtained

from human serum.• The fructosamine concentrations are lot-specific and are within the

pathological range.• ABX Pentra Fructo Control P should be used according to this

control notice. HORIBA ABX cannot guarantee its performance ifused otherwise.



2. Mix well. Avoid the formation of foam.3. Allow the solution to rest for at least 60 minutes before use.4. Use a pipette to transfer the required volume into a sample cup

and place it on the appropriate rack of the ABX Pentra 400 or Mira.5. Once reconstituted, treat the control serum like a patient specimen.The frequency of controls should correspond to the guidelines of theindividual laboratory.

Materials required but not provided• Automated clinical chemistry analyser.• Standard laboratory equipment.• Bidistilled water.

Assigned valuesThe given intervals and theoretical values have been determined andcalculated as follows: mean value ± 3 s (s corresponds to a valuederived from different determinations of theoretical values) measuredin at least 7 laboratories and in at least 3 independent series by meansof single determinations.The values have been obtained using test reagents and analysersystems available at the time of determination. The results must be within the range of the defined confidence limits.If a tendency towards higher or lower values is observed, or if thevalues are even above the dispersion limits, it is necessary to verifyeach step of the measurement process. Each laboratory shouldestablish a procedure to follow if the results exceed the specifieddispersion interval.The theoretical values, along with the exact dispersion intervals, arespecified in the enclosed annex, Ref. 04710794.


Storage and StabilityUnopened controls are stable up to the expiry date stated on the label.Following reconstitution, the control serum is stable for:


General Precautions1. Control, for professional in-vitro diagnostic use only.2. Follow proper laboratory handling precautions.3. This product has been prepared exclusively from blood proceeding

from donors which has been analysed individually in accordancewith the FDA-approved method. No HBs antigen or HIV / HCVantibody has been detected. However, since the absence of aninfection risk cannot be completely assured, this product should behandled with the same precautions that are applied to patientsamples. In case of exposure, follow local health authorityregulations (1,2).


WarningIt is the user's responsibility to verify that this document is applicableto the control used.


(29 CFR 1910. 1030). Federal Register. July 1, 1998 ; 6 : 267-280.2. Council Directive (90/679/EEC). Official Journal of the European

Communities No. L374 from Dec. 31, 1990 : 1-12.

1 week at 25 °C4 weeks at 2-8° C


Fructo Control PABX Pentra


N ControlABX Pentra

Form

-085

0 R

ev. 2

ABX Pentra N ControlRef.: A11A01653Volume: 10 x 5 ml

2007/05/24A93A00822D EN

A11A01653

10 x 5 ml

Normal control serum for the quality control of substrate, electrolyte, lipid, enzyme and protein assays.


Intended useABX Pentra N Control is a serum for the quality control of substrate,electrolyte, lipid, enzyme and protein assays. It can be used forchecking the accuracy and precision of assays carried out using theABX Pentra reagent range, for checking automated analytical methods.

Characteristics• ABX Pentra N Control is made of human serum. Its concentrations

and activities are mostly in the normal or near-normal range.

• ABX Pentra N Control is lyophilized. It is composed of human serumto which chemical substances and extracts from human - or animal -derived tissue have been added.


The concentrations of the constituents are lot-specific. Theoreticalvalues and their precise confidence intervals are given in the ABXPentra N Control enclosed annex, Ref. 04710795.

• ABX Pentra N Control should be used according to this controlnotice. HORIBA ABX cannot guarantee its performance if usedotherwise.

Handling1. Reconstitute the contents of one vial with 5.0 ml of distilled water

or deionised water.Be careful when opening the rubber cap as some lyophilizedmaterial may be lost.

ALT (GPT) Porcine heartAST (GOT) Porcine heartAlbumin Human serumAldolase Rabbit muscleAlkaline phosphatase Human placenta, recombinant

alkaline phosphataseAmylase (total) Human saliva, pig’s pancreasAmylase (pancreatic) Porcine pancreasCholesterol Bovine plasmaCholinesterase Human serumCreatine kinase Rabbit muscleγ -GT Porcine kidneysGLDH Bovine liverLD (LDH) Porcine heartLipase Human rek. pancreas lipaseAcid phosphatase Human prostate, potatoTotal proteins Human serum



Important: The determination of enzyme activity may be carried outimmediately in the case of all enzymes except for alkalinephosphatase. To reactivate alkaline phosphatase, incubate thereconstituted control serum for one hour at 25 °C.



An analysis of the control serum must be carried out on a daily basisat the same time as the patient samples, including each time acalibration is carried out. The frequency of the controls depends on thelaboratory requirements. Each laboratory must establish the qualityassurance procedures to be followed. These must conform to thecurrent accreditation requirements.


Assigned valuesa

The assigned values were determined using the method stated in theenclosed annex.Determinations were performed under strictly standardized conditionson HORIBA ABX analyzers using HORIBA ABX reagents and HORIBA ABXmaster calibrator.The target value is the median of all values obtained. Thecorresponding control range is calculated as the target value ± 3

a.Modification from index C to D: addition of informations.


N ControlABX Pentra

standard deviations (with the standard deviation being the valueobtained from several target value determination).Results must be within the range of the defined confidence limits.Each laboratory must establish the procedure to be followed in casethe results are outside of the confidence interval given.The control values are indicated in the enclosed annex, Ref. 04710795.The traceability of the target values is given in the instructions for useof the calibrator, ABX Pentra Multical, Ref. A11A01652.

Storage and StabilityControls, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-8 °C.

Stability of the parameters* after the reconstitution of ABX Pentra NControl:

*Exceptions : see below.

Stability of bilirubin following reconstitution away from light:

A slight green coloration of the control serum does not in any wayaffect theoretical values.Keep the reconstituted control serum vials tightly shut.


General Precautions1. This control is for professional in-vitro diagnostic use only.2. Observe the standard laboratory precautions for use. For France:

please refer to the Good Analytical Practice Handbook ( Guide deBonne Exécution des Analyses).

3. Although the controls have been prepared from blood derived fromdonors negative for HBs antigen, HIV1/2 antibody and HCVantibody, and because no test method can completely assure theabsence of HIV1/2, hepatitis B virus, hepatitis C virus, or otherinfectious agents, the controls should be treated like patientspecimens as potentially infectious and handled with appropriatecaution. In case of exposure, follow the guidelines of thecompetent health authorities (1,2).




(29 CFR 1910. 1030). Federal Register July 1, 1998 ; 6 :267-280.2. Directive of the European Council (90/679/CEE). Official Journal of

the European Community no. L374, 31.12.1990, pp. 1-12.

12 hours at 25°C5 days at 2 - 8°C1 month at -20°C (only one freezing session)

2 hours at 25°C6 hours at 2 - 8°C2 weeks at -20°C (only one freezing session)


P ControlABX Pentra

Form

-085

0 R

ev. 2

ABX Pentra P ControlRef.: A11A01654Volume: 10 x 5 ml

2007/05/24A93A00832D EN

A11A01654

10 x 5 ml

Pathological control serum for the quality control of substrate, electrolyte, lipid, enzyme and protein assays.


Intended useABX Pentra P Control is a serum for the quality control of substrate,electrolyte, lipid, enzyme and protein assays. It can be used forchecking the accuracy and precision of assays carried out using theABX Pentra reagent range, for checking automated analytical methods.

Characteristics• ABX Pentra P Control is made of human serum. Its concentrations

and activities are mostly in the pathological range.

• ABX Pentra P Control is lyophilized. It is composed of human serumto which chemical substances and extracts from human - or animal -derived tissue have been added.


The concentrations of the constituents are lot-specific. Theoreticalvalues and their precise confidence intervals are given in the ABXPentra P Control enclosed annex, Ref. 04710796.

• ABX Pentra P Control should be used according to this controlnotice. HORIBA ABX cannot guarantee its performance if usedotherwise.

Handling1. Reconstitute the contents of one vial with 5.0 ml of distilled water

or deionised water.Be careful when opening the rubber cap as some lyophilizedmaterial may be lost.

ALT (GPT) Porcine heartAST (GOT) Porcine heartAlbumin Human serumAldolase Rabbit muscleAlkaline phosphatase Human placenta, recombinant

alkaline phosphataseAmylase (total) Human saliva, pig’s pancreasAmylase (pancreatic) Porcine pancreasCholesterol Bovine plasmaCholinesterase Human serumCreatine kinase Rabbit muscleγ -GT Porcine kidneysGLDH Bovine liverLD (LDH) Porcine heartLipase Human rek. pancreas lipaseAcid phosphatase Human prostate, potatoTotal proteins Human serum



Important: The determination of enzyme activity may be carried outimmediately in the case of all enzymes except for alkalinephosphatase. To reactivate alkaline phosphatase, incubate thereconstituted control serum for one hour at 25 °C.



An analysis of the control serum must be carried out on a daily basisat the same time as the patient samples, including each time acalibration is carried out. The frequency of the controls depends on thelaboratory requirements. Each laboratory must establish the qualityassurance procedures to be followed, which must conform to thecurrent accreditation requirements.


Assigned valuesa

The assigned values were determined using the method stated in theenclosed annex.Determinations were performed under strictly standardized conditionson HORIBA ABX analyzers using HORIBA ABX reagents and HORIBA ABXmaster calibrator.The target value is the median of all values obtained. Thecorresponding control range is calculated as the target value ± 3

a.Modification from index C to D: addition of informations.


P ControlABX Pentra



Stability of the parameters* after the reconstitution of ABX Pentra PControl :

*Exceptions: see below.


A slight green coloration of the control serum does not in any wayaffect theoretical values. Keep the reconstituted control serum vials tightly shut.



please refer to the Good Analytical Practice Handbook (Guide deBonne Exécution des Analyses).










Urine Control L/H

ABX Pentra

Form

-085

0 R

ev. 2

ABX Pentra Urine Control L/HRef.: A11A01674Volume R1: 1 x 10 mlVolume R2: 1 x 10 ml

2008/05/15A93A00862C EN

A11A01674

Control urine for the quality control of HORIBA ABX methods.

1 x 10 ml

1 x 10 ml


Intended useABX Pentra Urine Control L/H is a urine for the quality control ofsubstrate, enzyme and protein assays. It can be used for checking theaccuracy and precision of assays carried out using the ABX Pentrareagent range, for checking automated analytical methods.

Characteristics• ABX Pentra Urine Control L/H is liquid and ready-to-use. It is

prepared from human urine with added constituents of human andanimal origin, chemicals, preservatives and stabilizers.

• ABX Pentra Urine Control L/H should be used according to thiscontrol notice and as specified in the respective instructions for useof the reagent. HORIBA ABX cannot guarantee its performance ifused otherwise.

HandlingBefore sampling, allow the control to reach room temperature (18-25°C) and swirl gently to ensure homogeneity.Remove the cap of the vial, transfer the control in a sample cup andplace in the correct position on the ABX Pentra 400 or Mira.

Materials required but not provided• HORIBA ABX reagents and clinical chemistry analyser.• Standard laboratory equipment.

Assigned valuesDeterminations were performed under strictly standardized conditionson HORIBA ABX analyzers using HORIBA ABX reagents and HORIBA ABXmaster calibrator.The target value is the median of all values obtained.Assigned values for both the high (H) and low (L) controls are lot-specific.Assigned values and precise confidence interval are indicated in theABX Pentra Urine Control L/H enclosed annex, Ref. 04710798.

Note: Creatinine values may gradually decrease over the product shelflife. Individual laboratory means may eventually fall outside of thecorresponding ranges printed in the enclosed annex.

This kit is composed of 2 vials:1 vial of control low (10 ml)1 vial of control high (10 ml)


Storage and StabilityControls, in unopened vials, are stable up to the expiry date on thelabel if stored at 2-8 °C.Once opened, ABX Pentra Urine Control L/H is stable for 30 days, at2-8°C, if recapped immediately after use.Proper storage and handling of this product must be observed.

Waste Management1. Please refer to local legal requirements.2. This control contains less than 0.1 % of sodium azide as a

preservative. As sodium azide may react with lead and copper toform explosive metal azides, this control should be disposed of byflushing with copious amounts of water.

General Precautionsa

1. ABX Pentra Urine Control L/H should be used only for qualitycontrol purpose only.

2. This control is for professional in-vitro diagnostic use only.3. Warning: Biological source material. Treat as potentially

infectious.The serum from each donor contributing urine for this product wastested by FDA accepted methods and found non-reactive forHepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C(HCV) and antibody to HIV-1/HIV-2. This product may also containother human source material for which there are no approved tests. The control should be treated like patient specimens as potentiallyinfectious and handled with appropriate cautions in accordancewith good laboratory practices.



a.Modification from index B to C: suppression of «Irritant».


Urine Control L/HABX Pentra


P ControlABX Pentra



Stability of the parameters* after the reconstitution of ABX Pentra PControl :

*Exceptions: see below.


A slight green coloration of the control serum does not in any wayaffect theoretical values. Keep the reconstituted control serum vials tightly shut.



please refer to the Good Analytical Practice Handbook (Guide deBonne Exécution des Analyses).










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