7 June 2013 326/MKT/Q Quantex HbA1c: IFCC ... - Biokit

7 th June 2013
326/MKT/Q
Quantex HbA 1c : IFCC Standardization and
Packaging change
Dear customer,
With the aim of continuous improvement of our products we would like to inform you
about the following changes in the HbA 1c products:
(1)-quantex HbA 1c standard multipoint (code 3000-2315) has been
standardized according to IFCC Reference Material.
(2)- quantex HbA 1c (code 3000-2314) has changed its packaging.
Summary and Intended use
Glycated hemoglobin concentrations (most commonly hemoglobin A 1c ; HbA 1c ) 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 HbA 1C are intended for the quantitative determination of
hemoglobin A 1C (HbA 1C ) in whole hemolyzed blood by turbidimetry. With the quantex
HbA 1C reagents both the concentration of total hemoglobin and the concentration of
HbA 1C have to be measured. Results of both determinations are expressed in mmol/L
based on the IFCC Reference Material. The reported HbA 1c result is calculated as a
mmol/mol of the total hemoglobin concentration using the following equation:
mmol/mol HbA 1c (IFCC) = HbA 1c (mmol/L) / Total Hb (mmol/L) x 1000
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

(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 HbA 1c results was one of the main
issues discussed and International Standardization of HbA 1c 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 HbA 1c 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 HbA 1c represents the only valid anchor to implement standardization of the measurement.
NGSP and IFCC units
Taking in account the Working Group on HbA 1c Standardization guidelines from IFCC (International
Federation of Clinical Chemistry), HbA 1c 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 HbA 1c would be expressed as mmol
HbA 1c /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.
HbA 1c 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 % HbA 1c and mmol/mol
Depending on the assay used, the reference range for HbA 1C 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.
Page 2 of 6

Standard values
Please, look at the attached table reporting the current standard target values (g/dL) of the quantex
HbA 1c 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).
Page 3 of 6

Control Values
Please, look at the attached table reporting the control values of the quantex HbA 1c 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).
The batches currently available in the market are:
-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
HbA 1c 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 (%).
Page 4 of 6

(2)- PACKAGING CHANGE
Quantex HbA 1c (code 3000-2314) has changed its packaging. The 100mL vials have been replaced for
50mL vials in the HbA 1c reagent (quantex HbA 1c 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:
quantex HbA 1c (Code: 3000-2314)
OLD PRESENTATION NEW PRESENTATION FIRST BATCH
Hemolyzing diluent: 1 x 50 mL (100 mL vial)
HbA 1c R1: 1 x 14 mL (20 mL vial)
Hemolyzing diluent: 1 x 50 mL (50 mL vial)
HbA 1c R1: 1 x 14 mL (20 mL vial)
Hb R1: 1 x 28 mL (100 mL vial)
HbA 1c R2: 1 x 14 mL (20 mL vial)
Hb R1: 1 x 28 mL (50 mL vial)
HbA 1c R2: 1 x 14 mL (20 mL vial)
B22774
Exp. Date: 31.01.2015
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 HbA 1c (3000-2314)
-quantex HbA 1c standard multipoint (3000-2315)
-quantex HbA 1c control I/II (3000-2316)
References
ILab TM 600/650 application
quantex HbA 1c 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 HbA 1c control I/II (3000-2316)
o Control values (mmol/mol and %) for the current lots in the market
o New values sheet template
Page 5 of 6

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:
montse.armengol@biokit.com
Sandra Roselló, Product Manager Quantex & Key
Account Manager:
sandra.rosello@biokit.com
Fran Sánchez, Product Manager Instrumentation:
fran.sanchez@biokit.com
Joaquín Ortiz, Group Product Manager:
Rapid Test, ELISA and BIO-FLASH Blood Bank
jortiz@biokit.com
Carlos Fernández, Product Manager Instrumentation :
cfernandez.cepeda@biokit.com
Jesús Balta, Marketing support:
jesus.balta@biokit.com
Joan Vilà, Key Account Manager: Werfen Companies
jvila@biokit.com
Jordi Gómez, Key Account Manager : OEM & Raw Materials
jordi.gomez@biokit.com
Ricard Forns, Marketing and Technical Services Manager
Product Manager BIO-FLASH
rforns@biokit.com
Page 6 of 6

quantex
quantex HbA 1C
READ HIGHLIGHTED CHANGES
1 x 50 ml HbA 1C (Diluent), 1 x 28 ml Hb R1 (Reagent)
3000-2314 1 x 14 ml HbA 1C R1 (Reagent), 1 x 14 ml HbA 1C R2 (Reagent)
Intended use
The reagents quantex HbA 1C are intended for the quantitative determination of hemoglobin A 1C (HbA 1C ) 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 A 1C 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 HbA 1C 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 HbA 1C 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 HbA 1C reagents both the concentration of total hemoglobin and the concentration of HbA 1C have to
be measured. Results of both determinations are expressed in mmol/l based on the IFCC Reference Material. 5,6 The
reported HbA 1C 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 HbA 1C :
The determination of HbA 1C is based on a latex agglutination inhibition assay.
The HbA 1C present in a sample reacts specifically with HbA 1C antibodies coated to the quantex HbA 1C latex
reagent, but as the specific binding site on each HbA 1C molecule is present only once, no agglutination occurs. To
induce the agglutination, the quantex HbA 1C agglutinator reagent, a synthetic polymer containing multiple copies
of the immunoreactive portion of HbA 1C is used to bind the free sites of the latex reagent.
In the absence of HbA 1C in the sample, the quantex HbA 1C agglutinator reagent and the quantex HbA 1C
latex reagent agglutinate, resulting in an increase in absorbance which can be measured by turbidimetry.
If sample contains HbA 1C , it reacts with antibody binding sites on the quantex HbA 1C latex reagent. In a
second reaction step, the quantex HbA 1C agglutinator reagent binds the remaining free binding sites on the
quantex HbA 1C latex reagent and the final absorbance decreases proportionally to the concentration of HbA 1C
in the sample.
The concentration of HbA 1C is then calculated using the following equation:
mmol/mol HbA 1C (IFCC) = HbA 1C (mmol/l) / Total Hb (mmol/l) x 1000
HbA 1c 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 (%) 23.50 5
NGSP (%) = 0.09148 IFCC (mmol/mol) + 2.152 5
BIOKIT, S.A. - Can Malé s/n - 08186 - Barcelona - SPAIN
3000-2314 01.2013 eng.doc

quantex
Reagents
- HbA 1C - quantex HbA 1C 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.
- HbA 1C R1 - quantex HbA 1C latex reagent:
Suspension of polystyrene latex particles coated with monoclonal antibodies to HbA 1C in a buffer. Contains
bovine serum albumin, 0.6% surfactant and 0.1% Proclin 150.
- HbA 1C R2 - quantex HbA 1C agglutinator reagent:
HbA 1C 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.
- HbA 1C R1 (Reagent) : Ready to use. Invert gently to mix well before first use. Avoid foam formation. Place
container in reagent tray.
- HbA 1C 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 HbA 1C 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 HbA 1C 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 HbA 1C standard level 1 only.
Calibration of the quantex HbA 1C reagents R1 and R2 is performed with quantex HbA 1C 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.
BIOKIT, S.A. - Can Malé s/n - 08186 - Barcelona - SPAIN
3000-2314 01.2013 eng.doc

quantex
Quality control
It is recommended to use two levels of controls such as quantex HbA 1C 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, HbA 1C 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 HbA 1C using the quantex HbA 1C
reagents. The range of results of HbA 1C 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
Method comparison
ILab 600
Replicates/ Mean CV Replicates/ Mean CV
runs (mmol/mol) (%) runs (mmol/mol) (%)
Within run 5/10 34 1.3 5/10 104 1.3
Total 5/10 34 1.9 5/10 104 1.8
Test instrument (y) ILab 650
Test reagent (y)
quantex HbA 1C
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 HbA 1C
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
HbA 1C : 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 eng.doc

quantex
quantex HbA 1C
READ HIGHLIGHTED CHANGES
1 x 50 ml HbA 1C (Diluent), 1 x 28 ml Hb R1 (Reagent)
3000-2314 1 x 14 ml HbA 1C R1 (Reagent), 1 x 14 ml HbA 1C 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, 5 th 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 - Barcelona - SPAIN
3000-2314 01.2013 references.doc

quantex
READ HIGHLIGHTED CHANGES
quantex HbA 1C standard multipoint
The quantex HbA 1C standard multipoint is intended for use in establishing the calibration curve for the
quantex HbA 1C reagents by turbidimetry.
Principle
When the standards, which contain HbA 1c , are mixed with the quantex HbA 1c reagents, an inhibition of the
agglutination occurs which can be measured by turbidimetry. This reagent is intended to be used together with the
quantex HbA 1c reagents; read carefully the instructions of these products before use.
Contents
- quantex HbA 1c 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
indicated on the standard insert data sheet.
Contain preservatives.
The concentrations in mmol/l are
Calibration of the quantex Hb hemoglobin reagent is performed with quantex HbA1c standard level 1 only.
Calibration of the quantex HbA 1c reagents R1 and R2 is performed with quantex HbA 1c 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 - Barcelona - SPAIN
3000-2315 01.2013 eng.doc

quantex
READ HIGHLIGHTED CHANGES
quantex HbA 1c control I/II
The quantex HbA 1c control I/II are intended for use in monitoring the quality control of results obtained with
the quantex HbA 1c reagents by turbidimetry.
Principle
When the controls, which contain human blood and HbA 1c , are mixed with the quantex HbA 1c reagents, an
inhibition of the agglutination occurs which can be measured by turbidimetry. This reagent is intended to be
used together with the quantex HbA 1c reagents; read carefully the instructions of these products before use.
Contents
- quantex HbA 1c 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.
BIOKIT, S.A. - Can Malé s/n - 08186 Lliçà d’Amunt - Barcelona - SPAIN
3000-2316 06.2012 eng.doc

quantex
quantex HbA 1C
1 x 50 ml HbA 1C (Diluent), 1 x 28 ml Hb R1 (Reagent)
3000-2314 1 x 14 ml HbA 1C R1 (Reagent), 1 x 14 ml HbA 1C R2 (Reagent)
ILab 600/650 Test Parameters
READ HIGHLIGHTED CHANGES
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.
BIOKIT, S.A. - Can Malé s/n - - Barcelona - SPAIN
3000-2314 01.2013 ILab600.doc

quantex
quantex HbA 1C
1 x 50 ml HbA 1C (Diluent), 1 x 28 ml Hb R1 (Reagent)
3000-2314 1 x 14 ml HbA 1C R1 (Reagent), 1 x 14 ml HbA 1C R2 (Reagent)
ILab 600/650 Test Parameters
READ HIGHLIGHTED CHANGES
Photometric Test Parameters
Test nº 98
Test Name, Test Code
HbA 1C, HbA 1C
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
HbA 1C 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.
BIOKIT, S.A. - Can Malé s/n - - Barcelona - SPAIN
3000-2314 01.2013 ILab600.doc

quantex
quantex HbA 1C
1 x 50 ml HbA 1C (Diluent), 1 x 28 ml Hb R1 (Reagent)
3000-2314 1 x 14 ml HbA 1C R1 (Reagent), 1 x 14 ml HbA 1C R2 (Reagent)
ILab 600/650 Test Parameters
Calculated Test Parameters
Test nº **
Test Name, Test Code
HbA 1C, (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.
READ HIGHLIGHTED CHANGES
ILab is a trademark of Instrumentation Laboratory.
BIOKIT, S.A. - Can Malé s/n - - Barcelona - SPAIN
3000-2314 01.2013 ILab600.doc

Page 1 of 1
Dear customer,
Below you could find the standard values of the quantex HbA 1c 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).
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)
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: biokit@biokit.com / www.biokit.com

Page 1 of 1
Dear user,
Below you could find the control values of the quantex HbA 1c 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).
The batches currently available in the market are:
-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 HbA 1c
control I/II (code: 3000-2316).
This difference is due to the fact that they have been reassigned using the IFCC standardized standards.
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: biokit@biokit.com / www.biokit.com

quantex HbA 1C standard multipoint
REF
LOT
3000-2315
XXXXXX
Level
HbA 1C
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

quantex HbA 1C control I/II
REF
LOT
3000-2316
XXXXXX
IFCC units
(mmol/mol)
ILab
Instruments
Mean / Media / Mittelwert /
Moyenne / Media / Média
Range / Rango / Bereich /
Intervalle / Intervallo /
Intervalo
I XX XX - XX
II XXX XX - XXX
HbA 1C %
Mean / Media / Mittelwert /
NGSP traceability
Moyenne / Media / Média
Range / Rango / Bereich /
Intervalle / Intervallo /
Intervalo
I X.X X.X - X.X
II X.X X.X - XX.X
3800-4343
04/13