Quantex HbA : IFCC Standardization and Packaging change/media/biokit/doc/news/2013/bkne… ·...

BIOKIT S.A. Can Malé, s/n. 080186 Lliçà d’Amunt Barcelona, Spain Tel. +34 93 860 9000 Fax +34 93860 9009 www.biokit.com

Dear customer,

With the aim of continuous improvement of our products we would like to inform you

about the following changes in the HbA1c products:

(1)-quantex HbA1c standard multipoint (code 3000-2315) has been

standardized according to IFCC Reference Material.

(2)- quantex HbA1c (code 3000-2314) has changed its packaging.

Summary and Intended use

Glycated hemoglobin concentrations (most commonly hemoglobin A1c; HbA1c) reflect

time averaged blood glucose during the previous 2-3 months and are used as the gold

standard for long-term follow-up of glycemic control. This parameter is independently

of circadian patterns, diet and other fluctuations. Numerous clinical studies have

shown that diabetes-related complications may be reduced by the long-term

monitoring and tight control of blood glucose levels.

The reagents quantex HbA1C are intended for the quantitative determination of

hemoglobin A1C (HbA1C) in whole hemolyzed blood by turbidimetry. With the quantex

HbA1C reagents both the concentration of total hemoglobin and the concentration of

HbA1C have to be measured. Results of both determinations are expressed in mmol/L

based on the IFCC Reference Material. The reported HbA1c result is calculated as a

mmol/mol of the total hemoglobin concentration using the following equation:

mmol/mol HbA1c (IFCC) = HbA1c (mmol/L) / Total Hb (mmol/L) x 1000

7th June 2013

326/MKT/Q

Quantex HbA1c: IFCC Standardization and Packaging change

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(1)- IFCC STANDARDIZATION National Scientific Societies and Associations have been worked in order to promote a coordinated plan

for implementing the standardization of glycated hemoglobin measurement according to the

recommendations of the IFCC Organization. Change of reporting HbA1c results was one of the main

issues discussed and International Standardization of HbA1c measurements became an important

objective for scientists and clinicians.

To overcome the lack of reference materials, achieve global standardization and meet the requirements

of the European Union directive on in vitro diagnostic medical devices (IVD), the IFCC established a

Working Group on HbA1c Standardization to develop a reference measurement system within the

concept of metrological traceability.

A first consensus meeting was held in 2007, where it was decided that the new IFCC reference system

for HbA1c represents the only valid anchor to implement standardization of the measurement.

NGSP and IFCC units

Taking in account the Working Group on HbA1c Standardization guidelines from IFCC (International

Federation of Clinical Chemistry), HbA1c results have to be reported by worldwide clinical laboratories in

IFCC units (mmol/mol , 0 decimals), which are the SI units (International System of Units), and derived

NGSP units (%, 1 decimal) using the IFCC-NGSP master equation.

A master equation was developed to document the relationship between NGSP and IFCC (NGSP =

[0.9148 x IFCC] + 2.152). In 2007, the IFCC recommended that IFCC HbA1c would be expressed as mmol

HbA1c/mol Hb. With these new units, the master equation changes to NGSP = [0.09148 x IFCC] + 2.152).

This change in units avoids any confusion between NGSP and IFCC results.

HbA1c results could be converted to IFCC (mmol/mol) or to NGSP (%) units using the following master equations from IFCC Organization:

IFCC (mmol/mol) = 10.93 x NGSP (%) – 23.50 1,2 NGSP (%) = 0.09148 x IFCC (mmol/mol) + 2.152 1,2 Reference range in % HbA1c and mmol/mol

Depending on the assay used, the reference range for HbA1C is approximately 4-6% (20-42 mmol/mol) in

non diabetics, 6-8% (42-64 mmol/mol) in controlled diabetics, and can be as much as 20% (195 mmol/mol)

in uncontrolled diabetics.

In any case, it is recommended that each laboratory establishes its own expected range.

References

1.-Weykamp C, John WG, Mosca A. A review of the Challenging in Measuring Hemoglobin HbA1c. J Diabetes Sci Technol. V3, Issue 3: 436-445, 2009. 2.-Hanas R, John WG, on behalf of the International HbA1c Consensus Committee. 2010 Consensus Statement on the Worldwide Standardization of the Hemoglobin A1c Measurement. Diabet Care. 33 (8): 1903-1904, 2010.

http://www.ncbi.nlm.nih.gov/pubmed/20636950

http://www.ncbi.nlm.nih.gov/pubmed/20636950

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Standard values

Please, look at the attached table reporting the current standard target values (g/dL) of the quantex

HbA1c standard multipoint (code: 3000-2315) included in the values sheet as reference, and the new IFCC

standardized target values (mmol/L).

The batches currently available in the market are:

-F-2912 (Exp date: 30/11/2013)

-A-2312 (Exp date: 30/11/2013)

-I-1211 (Exp date: 31/05/2013)

IMPORTANT NOTE: Starting lot number B22773 (Expiration date 30.11.2014), values sheet will contain only

the new IFCC standardized target values (mmol/L).

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Control Values

Please, look at the attached table reporting the control values of the quantex HbA1c control I/II (code:

3000-2316).

Table shows current values included in the values sheet (ILab instruments, %), values obtained using IFCC

standardized standards (mmol/mol) and the NGSP values (%) calculated through the master equation

reported on page 2 (NGSP (%) = 0.09148 x IFCC (mmol/mol) + 2.152).


-C-0812 (Exp date: 31/10/2014)

-A-2412(Exp date: 31/10/2014)

-I-1111 (Exp date: 31/05/2014)

-E-2111 (Exp date: 28/02/2014)

IMPORTANT NOTE: Please note that the NGSP target values (%) of Controls, reported in the above

tables differ from the current NGSP target values reported in the values sheet included in the quantex

HbA1c control I/II (code: 3000-2316).

This difference is due to the fact that they have been reassigned using the IFCC standardized standards.

IMPORTANT NOTE: Values sheet of next lot (pending to know the lot number) will contain values in IFCC

units (mmol/mol) and NGSP units (%).

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(2)- PACKAGING CHANGE

Quantex HbA1c (code 3000-2314) has changed its packaging. The 100mL vials have been replaced for

50mL vials in the HbA1c reagent (quantex HbA1c hemolyzing reagent) and Hb R1 reagent (quantex Hb

hemoglobin reagent).

Code, volumes and nº tests/kit are the same than the previous ones.

The new formats are the following:

The new 50mL vial for the Hb R1 reagent will allow to use it directly in the reagents rack in the ILab

Aries analyzer, as well as in the other members of the ILab family.

Along with the change of the vials, On-board stability and Calibration stability testing were done using

the ILab 600/650 analyzer.

ATTACHED INFORMATION

In this BK News you can find the following relevant information:

Insert sheets -quantex HbA1c (3000-2314) -quantex HbA1c standard multipoint (3000-2315) -quantex HbA1c control I/II (3000-2316)

References

ILabTM 600/650 application

quantex HbA1c standard multipoint (3000-2315) o Standard values (g/dL and mmol/L) for the current lots in the market o New values sheet template

quantex HbA1c control I/II (3000-2316) o Control values (mmol/mol and %) for the current lots in the market o New values sheet template

OLD PRESENTATION NEW PRESENTATION FIRST BATCH

Hemolyzing diluent: 1 x 50 mL (100 mL vial) Hemolyzing diluent: 1 x 50 mL (50 mL vial)

Hb R1: 1 x 28 mL (100 mL vial) Hb R1: 1 x 28 mL (50 mL vial)

HbA1c R1: 1 x 14 mL (20 mL vial) HbA1c R1: 1 x 14 mL (20 mL vial)

HbA1c R2: 1 x 14 mL (20 mL vial) HbA1c R2: 1 x 14 mL (20 mL vial)

B22774

Exp. Date: 31.01.2015

quantex HbA1c (Code: 3000-2314)

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We hope that the implementation of the IFCC Standardization and the new packaging will be very useful

for your daily work.

Moreover, we are sure that IFCC Standardization will increase the clinical quality of the control and

monitor of the diabetic patients and will help in the worldwide clinical approach of diabetis.

Do not hesitate to contact us for any further information you might require.

Biokit Marketing Team

Montse Armengol, Marketing assistant: [email protected]

Joaquín Ortiz, Group Product Manager: Rapid Test, ELISA and BIO-FLASH Blood Bank

[email protected]

Sandra Roselló, Product Manager Quantex & Key Account Manager:

[email protected]

Carlos Fernández, Product Manager Instrumentation : [email protected]

Fran Sánchez, Product Manager Instrumentation: [email protected]

Jesús Balta, Marketing support: [email protected]

Joan Vilà, Key Account Manager: Werfen Companies [email protected]

Jordi Gómez, Key Account Manager : OEM & Raw Materials [email protected]

Ricard Forns, Marketing and Technical Services Manager Product Manager BIO-FLASH

[email protected]

mailto:[email protected]



BIOKIT, S.A. - Can Malé s/n - 08186 - Barcelona - SPAIN 3000-2314 01.2013 eng.doc

quantex

quantex HbA1C 1 x 50 ml HbA1C (Diluent), 1 x 28 ml Hb R1 (Reagent) 3000-2314 1 x 14 ml HbA1C R1 (Reagent), 1 x 14 ml HbA1C R2 (Reagent) Intended use The reagents quantex HbA1C are intended for the quantitative determination of hemoglobin A1C (HbA1C) in whole hemolyzed blood by turbidimetry. Check with your distributor or with the Technical Department of BIOKIT, S.A. for other available applications than those enclosed.

1 for a summary of causes of increased or decreased hemoglobin A1C concentration. Summary/Principle Diabetes Mellitus is a disease associated with poor glycemic control. Numerous clinical studies have shown that diabetes-related complications may be reduced by the long-term monitoring and tight control of blood glucose levels. Blood glucose determination allow assessment of the current situation of the diabetic patient at the time of blood collection and the HbA1C value provides information about the average blood glucose concentration during the preceding 6-8 weeks, independently of circadian patterns, diet and other fluctuations. It is therefore, a long-term indicator of diabetic control, whereas, the measurement of blood glucose is only a short -term indicator.2-4 Glucose and other monosaccharides react with free amino groups of proteins. This irreversible reaction is referred to as glycosylation and the term glycohemoglobin is used for the spontaneous glycosylation of hemoglobins. The degree of glycosylation depends on the degree as well as the duration of the blood glucose elevation. Total glycohemoglobin is subdivided into fractions. The fraction HbA1C is produced by glycosylation of the free amino group of the N-terminal amino acid valine of the hemoglobin ß-chain with D-glucose.2-4 With the quantex HbA1C reagents both the concentration of total hemoglobin and the concentration of HbA1C have to be measured. Results of both determinations are expressed in mmol/l based on the IFCC Reference Material.5,6 The reported HbA1C result is calculated as a mmol/mol of the total hemoglobin concentration. Determination of total hemoglobin: The reaction is initiated by the addition of the pre-treated hemolyzed sample to the quantex Hb hemoglobin reagent resulting in a green solution. The method involves the conversion of all the hemoglobin derivatives into hematin, which allows the endpoint measurement of total hemoglobin. Determination of HbA1C: The determination of HbA1C is based on a latex agglutination inhibition assay. The HbA1C present in a sample reacts specifically with HbA1C antibodies coated to the quantex HbA1C latex reagent, but as the specific binding site on each HbA1C molecule is present only once, no agglutination occurs. To induce the agglutination, the quantex HbA1C agglutinator reagent, a synthetic polymer containing multiple copies of the immunoreactive portion of HbA1C is used to bind the free sites of the latex reagent. In the absence of HbA1C in the sample, the quantex HbA1C agglutinator reagent and the quantex HbA1C latex reagent agglutinate, resulting in an increase in absorbance which can be measured by turbidimetry. If sample contains HbA1C, it reacts with antibody binding sites on the quantex HbA1C latex reagent. In a second reaction step, the quantex HbA1C agglutinator reagent binds the remaining free binding sites on the quantex HbA1C latex reagent and the final absorbance decreases proportionally to the concentration of HbA 1C in the sample. The concentration of HbA1C is then calculated using the following equation: mmol/mol HbA1C (IFCC) = HbA1C (mmol/l) / Total Hb (mmol/l) x 1000 HbA1c results could be converted to IFCC (mmol/mol) or to NGSP units (%) using the following master equation from the IFCC:

IFCC (mmol/mol) = 10.93 NGSP (%) 23.505 NGSP (%) = 0.09148 IFCC (mmol/mol) + 2.1525

READ HIGHLIGHTED CHANGES


quantex

Reagents - HbA1C - quantex HbA1C hemolyzing diluent: Porcine pepsin in a buffer. Contains preservatives. - Hb R1 - quantex Hb hemoglobin reagent: 0.4% sodium hydroxide, 2.5% Triton and 2.5% octylphenoxypolyethoxyethanol. - HbA1C R1 - quantex HbA1C latex reagent: Suspension of polystyrene latex particles coated with monoclonal antibodies to HbA1C in a buffer. Contains

bovine serum albumin, 0.6% surfactant and 0.1% Proclin 150. - HbA1C R2 - quantex HbA1C agglutinator reagent: HbA1C hapten covalently attached to a polymer in a buffer. Contains bovine serum albumin, 0.2% surfactant and

0.1% Proclin 150. Reagents from different lots must not be interchanged. Precautions The quantex reagents are intended for IN VITRO diagnostic use. For professional use only. Flush drains with water thoroughly after disposing of the remains of reagents. Because no test method can offer complete assurance of the absence of infectious agents, this product sh ould be handled with caution.7 Dispose all used materials in a suitable biohazardous waste container. Reagent preparation - Hb R1 (Reagent) : Ready to use. Invert gently to mix well before first use. Avoid foam formation. Place

container in reagent tray. - HbA1C R1 (Reagent) : Ready to use. Invert gently to mix well before first use. Avoid foam formation. Place

container in reagent tray. - HbA1C R2 (Reagent) : Ready to use. Invert gently to mix well before first use. Avoid foam formation. Place

container in reagent tray. If necessary, transfer the material to the adequate container. Reagent storage and stability Reagents from unopened vials are stable until the expiration date shown on the vial when stored at 2 -8°C. Do not freeze. Opened reagents are stable 14 days when placed on board the ILab 600/650 instrument or 28 days after re-calibration. For optimal stability remove reagents from the system and store them at 2-8°C in the original vial securely closed. Samples Use whole blood or capillary blood samples. K-EDTA or ammonium heparin are recommended as anticoagulants. Other anticoagulants should be evaluated before use. Samples are stable at 2-8°C for 2 weeks or at -20°C for 6 months. Frozen samples should be thawed at room temperature, mixed thoroughly prior to use and should not be refrozen. NOTE: All blood samples should be mixed thoroughly immediately before assaying. Sample preparation Mix 10 μl of the whole blood sample with 400 μl of quantex HbA1C hemolyzing diluent (1:41 dilution). Avoid foam formation. Incubate for a minimum of 5 minutes at room temperature prior to testing. Stability of pre-treated sample The treated sample may be stored up to 8 hours at room temperature, or up to 48 hours at 2-8°C, if stored well closed. On storage, certain lysed samples may have a tendency to precipitate. Mix well the samples prior to analyzing. Calibration Use quantex HbA1C standard multipoint REF 3000-2315 which is standardized to the reference material purchased by the IFCC organization. Calibration of the quantex Hb hemoglobin reagent is performed with quantex HbA1C standard level 1 only. Calibration of the quantex HbA1C reagents R1 and R2 is performed with quantex HbA1C standards levels 1 to 6. The concentrations in mmol/l are indicated on the standard insert data sheet. Recalibrate every 14 days, when a new lot of reagent is used, when control recovery falls out of the expected range or when adjustments are made to the instrument.


quantex

Quality control It is recommended to use two levels of controls such as quantex HbA1C control I/II REF 3000-2316. Analyze controls at least once each day. Expected ranges can be found on the control insert sheet. The control values should be within the established range. Otherwise, corrective measures should be taken by the user. For identification and resolution of out-of-control situations, references such as Westgard et al.8 are recommended. Change in typical reagent blank absorbance may indicate reagent deterioration. If expected results are not obtained, do not use the kit. Interferences No significant interference from triglycerides up to concentrations of 1600 mg/dl, bilirubin up to concentrations of 30 mg/dl and rheumatoid factor up to 2000 IU/ml. For a comprehensive review of interfering substances, re fer to the publication by Young et al.9

Reference range Depending on the assay used, HbA1C is approximately 20-42 mmol/mol (4-6%) in non diabetics, 42-64 mmol/mol (6-8%) in controlled diabetics, and can be as much as 195 mmol/mol (20%) in uncontrolled diabetics. 124 apparently normal healthy donors undergoing physical examination were tested for HbA1C using the quantex HbA1C reagents. The range of results of HbA1C was of 26-44 mmol/mol (4.5-6.2%) and a mean of 35 mmol/mol (5.4%) resulted. In any case, it is recommended that each laboratory established its own expected range. Precision

ILab 600 Replicates/ runs

Mean (mmol/mol)

CV (%)

Replicates/ runs

Mean (mmol/mol)

CV (%)

Within run 5/10 34 1.3 5/10 104 1.3 Total 5/10 34 1.9 5/10 104 1.8

Method comparison

Test instrument (y) ILab 650 Test reagent (y) quantex HbA1C Comparison instrument and reagent (x) HPLC* Slope 1.005 y intercept -2.3 Range (mmol/mol) 26 - 114 Mean X (mmol/mol) 52 Mean Y (mmol/mol) 50 r 0.992 n 38

*HPLC values in mmol/mol were calculated from NGSP values in % using the IFCC master equations.

Test instrument (y) ILab 600 Test reagent (y) quantex HbA1C Comparison instrument and reagent (x) Immunoassay* Slope 0.985 y intercept -0.4 Range (mmol/mol) 31 - 103 Mean X (mmol/mol) 64 Mean Y (mmol/mol) 62 r 0.991 n 40

*Immunoassay values in mmol/mol were calculated from NGSP values in % using the IFCC master equations.

Linearity Total Hb : 3.5 to 15 mmol/l HbA1C : 15 to 150 mmol/mol (for total Hb of 8.60 mmol/l)

BIOKIT, S.A. - Can Malé s/n - 08186 - Barcelona - SPAIN 3000-2314 01.2013 references.doc

quantex

quantex HbA1C 1 x 50 ml HbA1C (Diluent), 1 x 28 ml Hb R1 (Reagent) 3000-2314 1 x 14 ml HbA1C R1 (Reagent), 1 x 14 ml HbA1C R2 (Reagent) References - Bibliografía - Literatur - Bibliographie - Bibliografia - Bibliografia - - Referencje 1. Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. 2nd Edition, AACC Press, 1989. 2. Mayer TK, Freedman ZR. Protein Glycosylation in Diabetis Mellitus: A Review of Laboratory Measurements

and of their Clinical Utility. Clin Chim Acta 127: 147-184, 1983. 3. Cohen MP. Perspective: Measurement of Circulating Glycated Proteins to Monitor Intermediate-Term

Changes in Glycaemic Control. Eur J Clin Chem Clin Biochem 30: 851-859, 1992. 4. Niederau CM, Reinauer H. Glycohemoglobins. In: Clinical Laboratory Diagnostics. Use and Assessment of

Clinical Laboratory Results. Thomas L. TH-Books, Frankfurt/Main, Germany,1998. 5. Weykamp C, John WG, Mosca A. A review of the Challenging in Measuring Hemoglobin HbA1c. J Diabetes

Sci Technol. V3, Issue 3: 436-445, 2009. 6. Hanas R, John WG, on behalf of the International HbA1c Consensus Committee. 2010 Consensus Statement on

the Worldwide Standardization of the Hemoglobin A1c Measurement. Diabet Care,. 33(8):1903-1904, 2010. 7. Biosafety in Microbiological and Biomedical Laboratories. CDC/NIH manual, 5th edition, 2007. 8. Westgard JO, Barry PL. Cost-Effective Quality Control: Managing the Quality and Productivity of Analytical

processes, AACC Press, 1986. 9. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th Edition, AACC Press, 2000.


BIOKIT, S.A. - Can Malé s/n - 08186 Lliçà - Barcelona - SPAIN 3000-2315 01.2013 eng.doc

quantex

quantex HbA1C standard multipoint The quantex HbA1C standard multipoint is intended for use in establishing the calibration curve for the quantex HbA1C reagents by turbidimetry. Principle When the standards, which contain HbA1c, are mixed with the quantex HbA1c reagents, an inhibition of the agglutination occurs which can be measured by turbidimetry. This reagent is intended to be used together with the quantex HbA1c reagents; read carefully the instructions of these products before use. Contents - quantex HbA1c standard multipoint REF 3000-2315. 1 x 8 ml, level 1. Alkaline solution containing 0.4% of sodium hydroxide. 5 x 2 ml, levels 2 to 6. Product of human origin standardized to the IFCC Reference Material.1 The concentrations in mmol/l are

indicated on the standard insert data sheet. Contain preservatives. Calibration of the quantex Hb hemoglobin reagent is performed with quantex HbA1c standard level 1 only. Calibration of the quantex HbA1c reagents R1 and R2 is performed with quantex HbA1c standards levels 1 to 6. NOTE: Substituting components of other manufacturers may affect the results of the assay. Precautions The quantex reagents are intended for IN VITRO diagnostic use. For professional use only. All human source material used in the preparation of this product was found to be negative for the presence of HIV-1/2 and HCV antibodies, as well as for the hepatitis B surface antigen, using a method approved by the Food and Drug Administration (USA). WARNING: POTENTIALLY BIOHAZARDOUS MATERIAL. Because no test method can offer complete assurance of the absence of infectious agents, this product should be handled with caution.2 Dispose all used materials in a suitable biohazardous waste container. Preparation Ready to use. Invert gently to mix well before first use. NOTE: STANDARDS DO NOT REQUIRE PRE-TREATMENT. Storage All quantex reagents will remain stable until the expiration date shown on the label if stored between 2-8°C. All of the quantex reagents contain preservatives, but are still susceptible to contamination. Handle with the normal precautions. Quality control After calibration, the control values should be within the established range. Otherwise, corrective measures should be taken by the user. References 1. HBA IFCC cal insert sheet. 2. Biosafety in Microbiological and Biomedical Laboratories. CDC/NIH manual, 5th edition, 2007.


BIOKIT, S.A. - Can Malé s/n - 08186 Lliçà d’Amunt - Barcelona - SPAIN 3000-2316 06.2012 eng.doc

quantex

quantex HbA1c control I/II The quantex HbA1c control I/II are intended for use in monitoring the quality control of results obtained with the quantex HbA1c reagents by turbidimetry. Principle When the controls, which contain human blood and HbA1c, are mixed with the quantex HbA1c reagents, an inhibition of the agglutination occurs which can be measured by turbidimetry. This reagent is intended to be used together with the quantex HbA1c reagents; read carefully the instructions of these products before use. Contents - quantex HbA1c control I/II REF 3000-2316. 2 x 0.25 ml control I, low level (lyophilized). 2 x 0.25 ml control II, high level (lyophilized). 1 x 2 ml reconstitution diluent. Contains < 0.1% sodium azide. Product of human origin. Refer to control insert data sheet for assayed values. NOTE: Substituting components of other manufacturers may affect the results of the assay. Precautions The quantex reagents are intended for IN VITRO diagnostic use. For professional use only. Sodium azide may react with lead or copper pipes and plumbing creating highly explosive metal azides. Flush drains with water thoroughly after disposing of the remains of reagents. All human source material used in the preparation of this product was found to be negative for the presence of HIV-1/2 and HCV antibodies, as well as for the hepatitis B surface antigen, using a method approved by the Food and Drug Administration (USA). WARNING: POTENTIALLY BIOHAZARDOUS MATERIAL. Because no test method can offer complete assurance of the absence of infectious agents, this product should be handled with caution. Dispose all used materials in a suitable biohazardous waste container. Preparation The controls should be reconstituted with 0.25 ml of reconstitution diluent. Allow reconstituted material to stand for 15 minutes. Prior to use, gently swirl the vials. NOTE: THE CONTROLS SHOULD BE TREATED IN THE SAME MANNER AS SAMPLES AND REQUIRE

PRE-TREATMENT PRIOR TO BE TESTED. Storage All quantex reagents will remain stable until the expiration date shown on the label if stored between 2-8°C. All of the quantex reagents contain preservatives, but are still susceptible to contamination. Handle with the normal precautions. Once reconstituted the controls can be used for 3 months if stored between 2-8°C. Do not freeze the reconstituted controls. Quality control The control values should be within the established range. Otherwise, corrective measures should be taken by the user. References 1. Biosafety in Microbiological and Biomedical Laboratories. CDC/NIH manual, 5th edition, 2007.


quantex

BIOKIT, S.A. - Can Malé s/n - - Barcelona - SPAIN 3000-2314 01.2013 ILab600.doc

quantex HbA1C 1 x 50 ml HbA1C (Diluent), 1 x 28 ml Hb R1 (Reagent) 3000-2314 1 x 14 ml HbA1C R1 (Reagent), 1 x 14 ml HbA1C R2 (Reagent) ILab 600/650 Test Parameters

Photometric Test Parameters Test nº 97 Test Name, Test Code Hb, Hb Sample Type Others (treated blood sample) Reporting Unit, Decimal Points mmol/l, 2 Reaction Cycle Standard Twin Analysis OFF Methodology Type, Measuring Point End point, 17 Photometric Methodology 1 Wavelength Primary/Secondary Wavelength 600 Sampling Conditions Sampling 1 Sample vol. 15 Sample/Diluent vol. 0/0 Sampling 2 Sample vol. 0 Sample/Diluent vol. 0/0 Sampling 3 Sample vol. 0 Sample/Diluent vol. 0/0 Sampling 4 0 Diluent Code Saline Diluent Warning Limit ** First Run Sampling 1 Below/Above Normal Range N/A Panic L N/A Panic H N/A Noise *** Prozone N/A HIGH!, ABS N/A Reagent volumes R1 Code 01971 Rgt/Dil. Vol., Stirring 195/5, ON Reagent Low Vol. Warning Limit *** Stability (days) 28 R2 Code Rgt/Dil. Vol., Stirring 0/0, no Low Vol. Warning Limit *** Stability (days) 28 Ranges and Evaluation Criteria Normal Range-Male * Normal Range-Female * Normal Range-Other * Valid Range 0.00 15.00* Hemolysis/Icterus/Lipemia Limit *** Reaction Slope Positive Absorbance Limit Above, 3200 Prozone Limit N/A Non Linear Limit N/A Slope/Intercept correction 1/0 Qualitative Report OFF Calibration Conditions Calibration 1 Point, Linear, 3 Reps Stability (days) 14 Calibrator, Concentration Hb Std.**** R-Blank Limit (mAbs) 100 Cal. Reps Range (%) *** Min. Cal. Response (mAbs) *** Cal. Factor Change (%) *** M-Point Curve Fit (%) N/A Auto R-Blank by Bottle ON

* Operator definable, see the insert. ** Operator definable. *** Optional. **** Lot dependent. See concentration on standard vial label or insert. N/A Not applicable to this test. ILab is a trademark of Instrumentation Laboratory.


quantex



Photometric Test Parameters Test nº 98 Test Name, Test Code HbA1C, HbA1C Sample Type Others (treated blood sample) Reporting Unit, Decimal Points mmol/l, 2 Reaction Cycle Standard Twin Analysis OFF Methodology Type, Measuring Point End point, 19/26 Photometric Methodology 1 Wavelength Primary/Secondary Wavelength 700 Sampling Conditions Sampling 1 Sample vol. 4 Sample/Diluent vol. 0/0 Sampling 2 Sample vol. 0 Sample/Diluent vol. 0/0 Sampling 3 Sample vol. 0 Sample/Diluent vol. 0/0 Sampling 4 0 Diluent Code Saline Diluent Warning Limit ** First Run Sampling 1 Below/Above Normal Range N/A Panic L N/A Panic H N/A Noise *** Prozone N/A HIGH!, ABS N/A Reagent volumes R1 Code 01981 Rgt/Dil. Vol., Stirring 95/5, ON Reagent R1 Low Vol. Warning Limit *** Stability (days) 28 R2 Code 01982 Rgt/Dil. Vol., Stirring 95/5, ON Reagent R2 Low Vol. Warning Limit *** Stability (days) 28 Ranges and Evaluation Criteria Normal Range-Male * Normal Range-Female * Normal Range-Other * Valid Range 0.00 - 2.40* Hemolysis/Icterus/Lipemia Limit *** Reaction Slope Positive Absorbance Limit Above, 3200 Prozone Limit N/A Non Linear Limit N/A Slope/Intercept correction 1/0 Qualitative Report OFF Calibration Conditions Calibration 6 Points, point to point, 2 Reps Stability (days) 14 Calibrator, Concentration HbA1C Std.**** R-Blank Limit (mAbs) 1800 Cal. Reps Range (%) *** Min. Cal. Response (mAbs) *** Cal. Factor Change (%) *** M-Point Curve Fit (%) N/A Auto R-Blank by Bottle ON

* Operator definable, see the insert. ** Operator definable. *** Optional. **** Lot dependent. See concentration on standard vial label or insert. N/A Not applicable to this test. ILab is a trademark of Instrumentation Laboratory.


quantex



Calculated Test Parameters Test nº ** Test Name, Test Code HbA1C, (mmol/mol) Sample Type N/A Reporting Unit, Decimal Points mmol/mol, 0 Equation ([HbA1c] / [Hb]) x 1000 Normal Range-Mate * Normal Range-Female * Normal Range-Other * Valid Range 15 150

* Operator definable, see the insert. ** Operator definable. N/A Not applicable to this test.

ILab is a trademark of Instrumentation Laboratory.


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A Werfen Group Company

Domicilio Social / Head Office: Can Malé s/n, 08186 Lliçà d'Amunt (Barcelona) Spain

Correspondencia / Mail: Aptdo. Correos / P.O. Box 24075 - 08080 Barcelona / Spain

Tel. (34)938609000 - Fax Admon. (34)938609009 / Comercial (34)938609017

E-mail: [email protected] / www.biokit.com

Dear customer,

Below you could find the standard values of the quantex HbA1c standard multipoint (code: 3000-2315).

Table shows the current standard target values (g/dL) included in the values sheet as reference and the new

IFCC standardized target values (mmol/L).


-F-2912 (Exp date: 30/11/2013)

-A-2312 (Exp date: 30/11/2013)

-I-1211 (Exp date: 31/05/2013)

of 1

A Werfen Group Company

Domicilio Social / Head Office: Can Malé s/n, 08186 Lliçà d'Amunt (Barcelona) Spain

Correspondencia / Mail: Aptdo. Correos / P.O. Box 24075 - 08080 Barcelona / Spain

Tel. (34)938609000 - Fax Admon. (34)938609009 / Comercial (34)938609017

E-mail: [email protected] / www.biokit.com

Dear user,

Below you could find the control values of the quantex HbA1c control I/II (code: 3000-2316).

Table shows current values included in the values sheet (ILab instruments , %), values obtained using IFCC

standardized standards (mmol/mol) and the NGSP values (%) calculated through the master equation (NGSP

(%) = 0.09148 x IFCC (mmol/mol) + 2.152).


-C-0812 (Exp date: 31/10/2014)

-A-2412(Exp date: 31/10/2014)

-I-1111 (Exp date: 31/05/2014)

-E-2111 (Exp date: 28/02/2014

IMPORTANT NOTE: Please note that the NGSP target values (%) of Controls, reported in the above tables

differ from the current NGSP target values reported in the values sheet included in the quantex HbA1c

control I/II (code: 3000-2316).

This difference is due to the fact that they have been reassigned using the IFCC standardized standards.

quantex HbA1C standard multipoint

3000-2315

XXXXXX

Level HbA1C

mmol/l

Total Hemoglobin

mmol/l

1 X XX.XX

2 X.XX -

3 X.XX -

4 X.XX -

5 X.XX -

6 X.XX -

3800-4342 04/13

LOT

REF

quantex HbA1C control I/II

3000-2316

XXXXXX

IFCC units

(mmol/mol) Mean / Media / Mittelwert / Moyenne / Media / Média

Range / Rango / Bereich / Intervalle / Intervallo /

Intervalo ILab

Instruments

I XX XX - XX

II XXX XX - XXX

HbA1C % Mean / Media / Mittelwert / Moyenne / Media / Média

Range / Rango / Bereich / Intervalle / Intervallo /

Intervalo NGSP traceability

I X.X X.X - X.X

II X.X X.X - XX.X

3800-4343 04/13

LOT

REF

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