Sóporte Técnico Kit 2 PDF

FOR INTERNAL USE ONLY.
NOT FOR CUSTOMER DISTRIBUTION
Technical Support Guide for the Use and Troubleshooting of the

VARIANT™ II TURBO HbA1c Kit - 2.0
PIN: 12000447
on the VARIANT™ II TURBO Hemoglobin Testing System
PIN: 270-2600 or PIN: 270-2601
April 5, 2017
The above content is for trained Bio-Rad personnel only
LB001293revB Technical Support Guide

FOR INTERNAL USE ONLY. NOT FOR CUSTOMER DISTRIBUTION
Clinical Systems Division
Table of Contents Page
Introduction 3
Procedural and Maintenance Changes 23
Technical Support FAQ 24-32
Tables
▪ Table 1: Kit Configuration Changes 4-7
▪ Table 2: Individual Kit Component Availability 8-9
▪ Table 3: Kit Buffer Usage 22
▪ Table 4: Additional Differences 33-36
Figures
Figure 1: Non-diabetic Patient 10
Figure 2: Diabetic Patient Report 11
Figure 3: Elevated HbF Patient Report 12
Figure 4: HbAE Patient Report 13
Figure 5: HbAD Patient 14
Figure 6: HbAS Patient 15
Figure 7: HbAC Patient 16
Figure 8: Elevated Labile A1c (LA1c) 17
Figure 9: Elevated Carbamylated Hemoglobin (CHb) 18
Figure 10: β-thalassemia trait sample 19
Figure 11: HbA2' (prime) sample 20
Figure 12: Summary Report 21
Figure 13: Parameter Selection Error Message 25
Figure 14: Results of Hemoglobin Interference Study 26
Figure 15: Results of Precision Study (%NGSP) 28
Figure 16: ADA HbA1c Range Recommendations 30
Figure 17: Drug Interferences 32
The above content is for trained Bio-Rad personnel only 2

Introduction
The VARIANT™ II TURBO HbA1c Kit – 2.0, PIN 12000447 project was executed to obtain
FDA clearance for a new Indication for Use as an aid in diagnosis of diabetes and as an aid in
identifying patients who may be at risk for developing diabetes. There are no formulation
changes to the VARIANT™ II TURBO HbA1c Kit – 2.0, PINs 12000447 from PINs 270-2455
and 270-2455EX. The product labeling for PIN 12000447 has new performance data in the
Instruction Manual which is different and more extensive than PINS 270-2455 and 270-2455EX
to meet the strict requirements by the FDA to support the new Indication for Use. The new part
number segregates the existing kit PINs 270-2455 and 270-2455EX in inventory until all
countries worldwide have converted customers to PIN 12000447.
This guide is intended to help the Technical Support groups navigate and quickly identify
possible problems and resolutions when troubleshooting with the customer.
Product Features
The VARIANT™ II TURBO HbA1c Kit – 2.0, PIN 12000447, provides:
Indications for Use

• Diagnosis: The test is to be used as an aid in diagnosis of diabetes and as an aid in
identifying patients who may be at risk of developing diabetes.
• Monitoring: Measurement of hemoglobin A1c is effective in monitoring long-term
glycemic control in individuals with diabetes mellitus.
Performance Characteristics
• HbA1c is reportable in the presence of HbF concentrations up to 25%.
• Carbamylated hemoglobin (CHb), labile A1c (LA1c) and acetylated hemoglobin do not
interfere with the assay at physiologically occurring concentrations.
• HbA1c is reportable in the presence of heterozygous hemoglobins E, D, S and C.
Expected Workflow
• The cartridge lifetime is 2500 injections.
• The cartridge on-board stability is 90 days.
• Double prime once after every new cartridge installation.
• Calibrate once after installation and priming of every new cartridge.
• The prefilter lifetime is 500 injections.
• The prefilter improves the overall performance of the cartridge.
• Different lots of Buffer A and Buffer B can be interchanged within a cartridge resin lot.
Buffer and cartridge labels are coded using an alphabetical letter to indicate
compatibility.

Table 1 - Kit Configuration Changes for the VARIANT™ II TURBO

HbA1c Kit - 2.0, PIN 12000447
Feature/Component VARIANT™ II TURBO HbA1c Kit -

2.0 (2500 Tests)
Kit Name and PIN VARIANT™ II TURBO Hemoglobin A1c

Kit – 2.0, PIN 12000447
2500 tests
Cartridges in kit 1 pouch (1 cartridge + 5 prefilters)
Cartridge lifetime 2500 injections or 90 days post
installation (whichever comes first)
Cartridge on-board stability Cartridge: 90 days post installation
Prefilter: 90 days post installation

Cartridge Length 38 mm
Cartridge Pressure 40-150 kg/cm2*
Cartridge Storage 2-8°C
Prefilter lifetime 500 injections per prefilter
Prefilter on-board stability 90 days post installation
Prefilter Storage 2-30°C
Cartridge Holder PEEK midsection and stainless steel
prefilter adapter, PIN 270-2463
Primer Vials in kit 2 vials
Primer Reconstituted 1 day at 2-8°C
Stability
Priming frequency Double prime after installation of every
new cartridge
*NOTE: Cartridge pressure range may change from resin lot to resin lot. Refer to the Cartridge
Resin Release Notes or Customer Notification: Release of VARIANT™ II TURBO HbA1c Kit -
2.0, REF 12000447 (12005280revA) for further details.


HbA1c Kit - 2.0, PIN 12000447

2.0 (2500 Tests)
Buffer A 5 Bottles (2500 mL each)
Sodium Perchlorate, Succinate and
<0.05% Sodium Azide formulation
Open stability: 30 days at 15-30°C
Buffer B 1 Bottle (2000 mL)
Sodium Perchlorate, Succinate and
<0.05% Sodium Azide formulation
Wash Diluent 1 x 4 Pack, 2500 Deionized water and <0.05% Sodium
ml each Azide
Use PIN 270-2730 (Wash/Diluent
Solution Set) to order
Calibrator vials 2 levels: 2 vials per level
Lyophilized human red cell hemolysate
with gentamycin, tobramycin and EDTA
formulation
Calibrator reconstitution volume 7 mL of Calibrator Diluent
Deionized water and <0.05% Sodium
Calibrator diluent formulation
Azide
Calibrator reconstituted stability 1 day at 2-8°C
Calibration frequency Once after installing and priming a new
cartridge
Blank samples used in calibration Quality control sample or patient sample
and patient sample runs prediluted 1:300 with Wash Diluent
Note: Do not use Calibrators as blanks as
there is not adequate volume
Sample vials 50 polypropylene microvials with
pierceable caps, 1.5 mL
PIN 12005138
CD Contains VARIANT™ II TURBO HbA1c
Kit - 2.0 test parameters.
PIN 12000997


HbA1c Kit - 2.0, PIN 12000447

2.0 (2500 Tests)
Summary report Columns for Variant and C

System decontamination As needed for troubleshooting
procedure* 5 microvial of bleach.
5 microvials of DI water
5 microvial of diluted (1:10) patient
whole blood
Specimen type Whole blood in vacuum collection tube
with K2-EDTA or K3-EDTA
Stability: Up to 7 days at 2-8°C or

1 day at 15-30°C (room temperature) or
up to 12 months at -70°C
Capillary blood collected in HCCS

(Hemoglobin Capillary Collection
System)
Pre-dilution for samples and Predilute whole blood samples 1:300
controls (add 1.5 mL of Wash Diluent and 5µL
of sample to a 1.5 mL microvial)
If no dilution instructions are provided
for controls samples, predilute 1:300 as
described above.
Performance Claims VARIANT™ II TURBO HbA1c Kit -
2.0 (2500 Tests)
HbF interference** HbA1c is reportable up to 25% HbF**

Carbamylated hemoglobin (CHb) No interference at physiologically
occurring concentrations
Labile A1c (LA1c) No interference at physiologically
Acetylated hemoglobin No interference at physiologically
*NOTE: Refer to VARIANT™ II TURBO Hemoglobin Testing System Operation Manual

(LB0001503 or later) for full instructions.
**NOTE: Any sample with HbF >5% may result in higher than expected HbA1c values and
should be suspected of having a hemoglobinopathy. Refer to the VARIANT™ II TURBO HbA1c
Kit - 2.0 Instructions for Use (12005531revB) for further details.


HbA1c Kit - 2.0, PIN 12000447
Performance Claims VARIANT II TURBO 2.0 (2500

Tests)
HbS trait, HbC trait, HbD trait HbA1c is reportable in the presence of
and HbE trait the heterozygous forms of these traits
NOTE: The homozygous and double-

heterozygous forms of these traits lack
HbA, so no HbA1c can be determined.
HbA2 No interference*
P3 ≤5% for hemoglobin variant samples
(i.e., HbS-, HbC-, HbD-, and HbE-trait)
P3 and P4 ≤10% for non-variant samples
Common drugs HbA1c is reportable at therapeutic
concentrations**
Lipemia HbA1c is reportable up to
6000mg/dL or 60 g/L
Conjugated bilirubin HbA1c is reportable up to
60 mg/dl or 712 µmol/L
Unconjugated bilirubin HbA1c is reportable up to
60 mg/dL or 1026 µmol/L
Glucose HbA1c is reportable up to
2000 mg/dL or 111 mmol/L
Rheumatoid factor HbA1c is reportable up to
750 IU/mL or 750 kIU/L
Total protein HbA1c is reportable up to
21 g/dL or 210 g/L
Total area range 1 million - 3.5 million
Linearity NGSP % HbA1c: 3.4-20.6
IFCC mmol/mol HbA1c: 14-203
Reportable range NGSP % HbA1c: 3.4-20.6
IFCC mmol/mol HbA1c: 14-203
*NOTE: Refer to page 27 of the Tech Support FAQ section for additional information.
**NOTE: Refer to Figure 17 on page 32 of the Tech Support FAQ section for
additional information.

Table 2 – Individual Kit Component Availability for the VARIANT™ II

TURBO HbA1c Kit - 2.0, PIN 12000447
Cat No. Description Quantity Availability in SAP as

in Kit separate component
12000447 VARIANT II TURBO N/A Available for individual sale
HbA1c Kit – 2.0 or technical replacement
270-0350 Whole Blood Primer 2 Vials Not available for individual
Lyophilized sale.
Reconstitute 1.0mL / vial Available in SAP for technical
replacement only
270-2456 Elution Buffer A 5 Bottles Available for individual sale
2500mL per bottle or technical replacement
270-2457 Elution Buffer B 1 Bottle Available for individual sale
2000mL per bottle or technical replacement
270-2458 Calibrator / Diluent Set 1 set Available for individual sale
2 vials Cal 1 and 2 vials Cal or technical replacement
2 (lyophilized)
1 bottle Cal Diluent
(100mL)
12000997 CD with VARIANT II 1 CD Not available for individual
TURBO HbA1c Kit – 2.0 sale.
test parameters Not available in SAP for
technical replacement
270-2462 Analytical cartridge 1 Each Not available for individual
1 analytical cartridge (2500 sale.
tests); 5 prefilters (500 tests) Available in SAP for technical
replacement only
12005138 Sample Vials 1 each Available for individual sale
50 microvials, 1.5mL or technical replacement
270-2730 Wash/Diluent Solution set 1 set Available for individual sale
4 bottles, 2500mL each (provided or technical replacement
as extra
box) Individual Wash/Diluent
bottle in set (PIN 270-2729) is
not available for individual
sale or technical replacement

Table 2 – Individual Kit Component Availability for the VARIANT™ II

TURBO HbA1c Kit - 2.0, PIN 12000447
Cat No. Description Quantity in Availability in SAP as

Kit separate component
Additional Items Available
270-0351 Whole Blood Primer - 10 1 package Available for individual sale
vials or technical replacement
Lyophilized
Reconstitute 1.0mL / vial
270-0352 Whole Blood Primer - 6 1 package Available for individual sale
vials or technical replacement
Lyophilized
Reconstitute 1.0mL / vial
270-2464 Prefilters (package of 2) 1 package Available for individual sale
or technical replacement
196-2051 Hemoglobin Capillary Available for individual sale
Collection System (HCCS), 1 package or technical replacement
5 tests
100 tests
5000 tests

Chromatography Differences, Report Layouts and Examples of Chromatograms
Figure 1: Non-diabetic patient report from VARIANT™ II TURBO HbA1c Kit - 2.0;
Note the arrows showing IFCC and NGSP result options with CDM 5.1 and above.

Figure 2: Diabetic sample on VARIANT™ II TURBO HbA1c Kit - 2.0

Figure 3: Elevated HbF on VARIANT™ II TURBO HbA1c Kit - 2.0

Figure 4: HbAE on VARIANT™ II TURBO HbA1c Kit - 2.0

Figure 5: HbAD on VARIANT™ II TURBO HbA1c Kit - 2.0

Figure 6: HbAS and Multiple Unknown Peaks on VARIANT™ II TURBO HbA1c Kit - 2.0

Figure 7: HbAC on VARIANT™ II TURBO HbA1c Kit - 2.0

Figure 8: Elevated Labile A1c (LA1c) on VARIANT™ II TURBO HbA1c Kit - 2.0

Figure 9: Elevated Carbamylated Hemoglobin (CHb) on VARIANT™ II TURBO HbA1c

Kit - 2.0. Note CHb elutes in the LA1c window.

Figure 10: β-thalassemia trait sample.

NOTE: Refer to page 27 of the Tech Support FAQ section for additional information.

Figure 11: HbA2' (prime) sample. The HbA1c is reportable.

V2_Turbo_A1c_2.0
Figure 12: Summary Report with VARIANT™ II TURBO HbA1c Kit - 2.0

Table 3 - Kit Buffer Usage Chart for the VARIANT™ II TURBO

HbA1c Kit - 2.0, PIN 12000447
The following is the buffer configuration for the VARIANT™ II TURBO HbA1c Kit – 2.0,
2500 Tests (PIN 12000447):
• 270-2456, Buffer A: Five (5) bottles, 2500 ml each

• 270-2457, Buffer B: One (1) bottle, 2000 ml
• 270-2730, Wash/Diluent: Four (4) bottles, 2500 ml each*
*NOTE: Wash/Diluent is available as a separate pack (270-2730) of four (4) bottles, 2500
ml each. At least one box of four (4) bottles is required for each kit.
The following grid estimates how many additional Buffer A and Buffer B and Wash buffer
bottles a customer will require per kit based on their workflow. See example on next page.
EXAMPLE (see highlighted sections in Table 2 above):
In order to run 2500 tests, a customer running fifty (50) samples per day over three (3) runs that
same day would need to order:
• One (1) VARIANT II TURBO HbA1c Kit - 2.0

• One (1) box of Wash/Diluent (contains four (4) bottles of Wash/Diluent)
• One (1) additional bottle of Buffer B
• One (1) additional box of Wash/Diluent (of which three (3) of the four (4) bottles would
be needed).

Procedural and Maintenance Changes for the Use of the VARIANT™ II

TURBO HbA1c Kit – 2.0, PIN 12000447
Which cartridge holder accommodates the cartridge and prefilter?
The VARIANT™ II TURBO 2.0 Cartridge Holder (PIN. 270-2463) should be installed on
instruments and is included in the VARIANT™ II TURBO 2.0 Upgrade Kit (PIN 270-2100).
Please confirm this cartridge holder is installed prior to running the VARIANT™ II TURBO
HbA1c Kit – 2.0 (PIN 270-2455/2455EX or 12000447). The cartridge should be installed with
the arrow pointing up. The prefilter can be installed in either direction initially. However, if the
prefilter has not reached the 500 injection limit and needs to be removed and reinstalled later,
draw an arrow on it pointing in the direction of flow using a permanent marker. The direction of
a prefilter should never be reversed.
Database maintenance when switching to the VARIANT™ II TURBO HbA1c Kit – 2.0
When switching from another method to the VARIANT™ II TURBO HbA1c Kit – 2.0, PIN
12000447, the current database must be backed up and cleared and CDM must be restarted prior
to installing the new Update Kit CD. This is necessary for laboratories using the QC Data feature
of the Clinical Data Management (CDM) system to generate Levey-Jennings charts or export
result to Unity
Calibration Frequency
Calibration only needs to be performed once after the installation and priming of a new
analytical cartridge. This will cover an injection limit of 2500 or 90 days (cartridge on-board
stability) whichever comes first.
Pressure Differences
The acceptable cartridge operating pressure range is 40-150 kg/cm2. The pressure range may
vary slightly in resin lots. Refer to the Cartridge Resin Release Notes or Customer Notification:
Release of VARIANT™ II TURBO HbA1c Kit - 2.0, REF 12000447 (12005280revA) for details.
Over the lifetime of a cartridge and prefilter, there can be an increase of pressure. Small
particulates from rotor seals, pump seals or other sources can contribute to increased pressure
during the lifetime. This is typical performance.
LIS Output
Switching from PIN 270-2455 (VARIANT™ II TURBO HbA1c Kit – 2.0) or PIN 270-2455EX
(VARIANT™ II TURBO HbA1c Kit – 2.0 – Export Only) to PIN 12000447 (VARIANT™ II
TURBO HbA1c Kit – 2.0) requires no changes to LIS. Switching from other kits to PIN
12000447 requires no changes to LIS, if only reporting HbA1c.

Tech Support FAQ: Frequently Asked Questions for Tech Support Issues
Customers will ask questions regarding some, if not all, of the changes made. This next section
is intended to help explain some anticipated questions the customer may ask.
Why is there a new PIN (Product Identification Number or part number)?

One purpose of the new part number (12000447) segregates the existing kit PINs 270-2455 and
270-2455EX in inventory until all countries worldwide have converted customers to PIN
12000447. Since the IFU’s are different and active for all three kits at the same time, different
PINs are required. Additionally, PIN 12000447 has a different intended use as explained in the
Introduction section on page 3 of this document.
Can this kit be installed on the VARIANT™ II TURBO Link Hemoglobin Testing System?
Yes. The VARIANT™ II TURBO Link Hemoglobin Testing System Operation Manual or
Quick Guide should be referenced for additional information. The VARIANT™ II TURBO
Link Hemoglobin Testing System is only available in the US and Canada.*
Why does the Update Kit CD (PIN 12000997) contain two parameter sets?
One parameter set is for the use of this assay on the VARIANT™ II TURBO Hemoglobin
Testing System (PIN: 270-2600 or PIN: 270-2601). The other parameter set is specific for the
use of this assay on the VARIANT™ II TURBO Link Hemoglobin Testing System (PIN: 270-
2700 or PIN: 270-2701). The VARIANT™ II TURBO Link Hemoglobin Testing System is
only available in the US and Canada.* Unique report headers will distinguish one system from
the other when this assay is in use.
• VARIANT™ II TURBO Hemoglobin Testing System (PIN: 270-2600 or PIN: 270-

2601:
• VARIANT™ II TURBO Link Hemoglobin Testing System (PIN: 270-2700 or PIN:

270-2701):
*NOTE: This Technical Support Guide is for the VARIANT™ II TURBO HbA1c Kit - 2.0 (PIN:
12000447) run on the VARIANT™ II TURBO Hemoglobin Testing System.

Will an error be triggered if the incorrect parameter set is selected?

Yes. The following error message will occur: “The version of this test is not compatible with the
current CDM version and cannot be imported.” See Figure 13.
Figure 13: Parameter Set Selection Error
Is recalibration necessary with buffer lot changes?

No, recalibration is not necessary with buffer lot changes.
Is priming or calibrating necessary when the prefilter is changed?

No. The prefilters have been pre-treated and are ready for use.
The IFU states HbA1c should not be reported if the following conditions are exhibited:
• P3 is ≤5% for hemoglobin variant samples

• P3 is ≤10% for non-variant samples
• P4 is ≤10%

Is HbA1c reportable if the P3 and P4 peaks are added together and is greater than 10?
Each peak should be evaluated separately. If each individual peak is less than
the concentrations defined above, then the HbA1c can be reported. For example, if P3 is ≤5% and
P4 is ≤10% for hemoglobin variant samples (HbS-, HbC-, HbD-, HbE-trait), the HbA1c can be
reported. Do not add the peaks together!
Why doesn’t Carbamylated Hb (CHb) have a peak window?

CHb will elute in the Labile A1c (LA1c) window. By moving the CHb peak further away from
the HbA1c peak, a more accurate HbA1c value is obtained as it decreases the chance of high CHb
values coeluting/interfering with HbA1c.
Where does the HbS peak elute?

The HbS peak will elute in the Variant window.
Explain the hemoglobin variant interference studies.

To obtain the new intended use, a study was performed to determine the effect of hemoglobin S,
C, D and E variant trait interference on HbA1c measurement. The study was performed according
to FDA and CLSI EP07-A2 guidelines (“Interference Testing in Clinical Chemistry.”) Samples
for the study consisted of whole blood patient samples with the hemoglobin variant
concentrations at levels typically found in heterozygous individuals (up to 30%- 40%). The
HbA1c values from these samples run on the VARIANT™ II TURBO Hemoglobin Testing
System using the VARIANT™ TURBO HbA1c Kit – 2.0 were compared to the NGSP assigned
values. Per FDA requirement, the Relative % Bias was calculated with hemoglobin
concentrations of approximately 6.5% (48 mmol/mol) and ≥8.0% (≥64 mmol/mol) HbA1c. The
FDA required the results to be reported as the (+/-) standard deviation of the relative % bias. The
study concludes that HbS, HbC, HbD and HbE traits do not interfere with the assay. See Figure
14.
Figure 14: Results of Hemoglobin Interference Study from the VARIANT™ II TURBO
HbA1c Kit - 2.0 Instructions for Use (12005531revB)
NOTE: Relative % Bias (StDEV) results are mean values obtained across the entire study
for each represented Hb variant trait.

What happens when a peak is identified in the Variant window?
HbA1c is reportable in the presence of HbS-, HbC-, HbD- and HbE. The graphs in Figures 4, 5,
6, and 7 can be used as guides. If a graph presentation differs from those examples, then it is
recommended that the customer follow their site procedures.
Why is HbA2 not identified in the peak table?

The intended use of the VARIANT™ II TURBO HbA1c Kit – 2.0 is for the quantitative
determination of HbA1c. HbA2 is neither calibrated nor controlled.
Does HbA2 interfere with the assay?

β-thalassemia trait, as indicated by increased HbA2 concentrations, does not interfere with this
assay.
Will the HbA2 be automatically excluded from the final HbA1c calculation when HbE trait
is present? If not, how will this impact the final HbA1c value?
Yes, HbA2 will be excluded. The calibration of normal samples, control samples and the
calibrators is determined by excluding normal amounts of HbA2. When HbE trait samples are
run, the applied calibration already factors the removal of a normal amount of HbA2.

Explain the precision study.

Figure 15 provides a summary of results from the precision study that was performed and submitted to the
FDA. The study design was based on the CLSI EP05-A2 guideline “Evaluation of Precision Performance
of Quantitative Measurement Methods” using a modified study design. Samples were run in duplicate in
2 runs per day on 3 instruments for 20 days. The study was repeated using 3 different kit lots. This
yielded a total of 720 results per sample over a 60-day period. The study target CV (Coefficient of
Variation) was ≤3% CV for %NGSP results.
Figure 15: Results of Precision Study (%NGSP) from the VARIANT™ II TURBO
HbA1c Kit - 2.0 Instructions for Use (12005531revB)

How should customers perform their precision study when installing an HbA1c diagnostic
kit?
The precision study performed by Bio-Rad and submitted to the FDA is an extensive study and is not
feasible for customers to perform. Customers should follow their site procedures for determining
acceptable precision. Customers can use a target CV of ≤3% for %NGSP results and opt for the example
defined in the CLSI precision protocol CLSI EP15-A2 “User Verification for Performance of Precision;
Approved Guideline – Second Edition,” Vol 25, No. 17”*. The example protocol involves analyzing 2
patient sample concentrations and controls in 1 run per day with 3 replicate samples each for 5 days using
one kit lot. Then the following %CV’s can be calculated: Within-run precision (or repeatability), and
within-laboratory precision.
Why is the IFU %CV different than CAP %CV?
The IFU %CV target of ≤3% was used to determine within-laboratory precision. The precision results
posted on the NGSP website from CAP surveys reflect the between-laboratory reproducibility. NGSP
uses a target of ≤3.5%, which is an arbitrary limit. (http://www.ngsp.org/CAPdata.asp)
*CLSI EP15-A2, “User Verification for Performance of Precision; Approved Guideline – Second
Edition,” Vol 25, No. 17, pgs. 4, 5 and 45. Bio-Rad cannot provide this CLSI document to customers due
to copyright laws, so if interested, contact CLSI directly at Clinical and Laboratory Standards Institute,
940 West Valley Road, Suite 1400, Wayne, Pennsylvania, 19087-1898, USA.

Can this assay be used to monitor people with diabetes?
Yes. This HbA1c method can be used to monitor long-term glycemic control in all individuals
with diabetes.
Can this assay be used as an aid in identifying patients who may be at risk for developing
diabetes?
Yes.
Can this assay be used as an aid in diagnosing diabetes?

Yes.
Explain the criteria for identifying patients at risk for developing diabetes and as an aid in
diagnosing diabetes.
HbA1c testing has been recommended for the diagnosis of Type 2 diabetes by the International
Expert Committee (IEC)*, the American Diabetes Association (ADA)**, and the World Health
Organization (WHO).*** All three bodies recommend a diagnostic threshold of ≥6.5% or
≥48 mmol/mol. The following HbA1c ranges in Figure 16 recommended by the American
Diabetes Association (ADA) may be used as an aid in the diagnosis of diabetes mellitus and
those at risk for developing diabetes (also known as “pre-Diabetic”). For diagnosis purposes,
results should be interpreted in conjunction with the patient’s medical history and clinical
findings. See Figure 16.
Figure 16: ADA HbA1c Range Recommendations
Can A1c be used to diagnose diabetes exclusively?

No. A1c is one indicator that is used by physicians to aid in the diagnosis of diabetes.
*International Expert Committee. Report on the Role of the A1c Assay in the Diagnosis of
Diabetes. Diabetes Care 2009, 32 (7). 1327-1334.
**American Diabetes Association, Diagnosis and Classification of Diabetes Mellitus. Diabetes
Care 2010, 33 (Suppl. 1), S62-S69.
***World Health Organization. Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of
Diabetes Mellitus. http://www.who.int/diabetes/publications/diagnosis diabetes2011/en/
(accessed July 2014).

What are the Special Considerations?

• The HbA1c test is not intended for analysis of samples collected from newborns.
• The HbA1c test should not be used to replace glucose testing in pediatric patients, pregnant
women, or patients with Type 1 diabetes.
• In cases of rapidly evolving Type 1 diabetes, the increase of HbA1c values might be delayed
compared to the acute increase in glucose concentrations. In these conditions, diabetes mellitus
must be diagnosed based on plasma glucose concentration and/or the typical clinical symptoms.
• The HbA1c test should not be used to diagnose diabetes during pregnancy or to diagnose
gestational diabetes.
• The HbA1c test should not be used to diagnose diabetes in patients with the following
conditions:
□ Any condition that alters the life span of the red blood cells, including recent blood loss,
transfusion, significant iron deficiency, hemolytic anemia (including hereditary
spherocytosis) or other hemolytic diseases, hemoglobinopathies and thalassemias, as the
altered red blood cell turnover interferes with the relationship between mean blood glucose
and HbA1c values.
|□ Malignancies or severe chronic hepatic and renal disease.

Was a drug interference study performed?
Yes. A new drug interference study was performed based on the CLSI EP07-A2 guideline,
“Interference Testing in Clinical Chemistry” to determine the effect of common drugs on HbA1c
measurement. Specimens with hemoglobin concentrations of approximately 6.5%
(48 mmol/mol) and ≥8.0% (≥64 mmol/mol) were spiked with the interferent drug. The study
concludes that the tested common drugs at therapeutic concentrations do not interfere with this
assay. See Figure 17.
Potential Drug Interferent Highest Level Tested showing no Significant Interference
Conventional Units (US) International System of

Units (SI)
Acetylcysteine 166 mg/dL 10.2 mmol/L
Ampicillin-Na 1000 mg/dL 28.65 mmol/L
Ascorbic acid 300 mg/dL 17.05 mmol/L
Cefoxitin 2500 mg/dL 58.55 mmol/L
Heparin 5000 U/L NA
Levodopa 20 mg/dL 1015 µmol/L
Methyldopa 20 mg/dL 948 µmol/L
Metronidazole 200 mg/dL 11.7 mmol/L
Doxycyclin 50 mg/dL 1124 µmol/L
Acetylsalicylic acid 1000 mg/dL 55.51 mmol/L
Rifampicin 64 mg/L 78 µmol/L
Cyclosporine 5 mg/L 4 µmol/L
Acetaminophen 200 mg/L 1323 µmol/L
Ibuprofen 500 mg/L 2427 µmol/L
Theophylline 100 mg/L 556 µmol/L
Phenylbutazone 400 mg/L 1299 µmol/L
Figure 17: Drug Interferences

Table 4 - Additional Differences Between PIN 12000447 (VARIANT™ II

TURBO HbA1c Kit - 2.0) vs. PIN 270-2455 (VARIANT™ II TURBO HbA1c
Kit – 2.0) and PIN 270-2455EX (VARIANT™ II TURBO HbA1c Kit – 2.0 –
Export Only)
NOTE: Bold text indicates a difference.
Feature/Component PIN 12000447 PIN 270-2455 PIN 270-2455EX

VARIANT™ II VARIANT™ II VARIANT™ II
TURBO HbA1c Kit - TURBO HbA1c Kit – TURBO HbA1c Kit –
2.0 2.0 2.0 – Export Only
QC Requirement Run once each day Include with every run Include with every run
A repeat run is A repeat run is

Each lab should indicated when indicated when
establish its own expected control expected control
guidelines for values are not values are not
corrective actions obtained. obtained
Sample Vials Sample vials Sample vials Sample vials:
PIN: 12005138: PIN: 270-2149: PIN: 270-2149:
50 polyproplene 100 polyproplene 100 polyproplene
microvials with microvials with microvials with
pierceable caps, 1.5 pierceable caps, 1.5 pierceable caps, 1.5
mL. mL. mL.
Update Kit CD CD CD-ROM CD-ROM
1 CD contains 2 1 CD contains 1 1 CD contains 1

parameter sets with parameter set parameter set
the VII Link set for
US and Canada only
PIN 12000997 PIN 2702461 PIN 2702461


Export Only)
NOTE: Bold text indicates a nomenclature difference only.

Buffer A 5 Bottles (2500 mL Same Same

each)
Succinate/Sodium
Perchlorate and
<0.05% Sodium Azide
formulation
Open stability: 30
days at 15-30°C
Buffer B 1 Bottle (2000 mL) Same Same
Succinate/Sodium
Perchlorate and
<0.05% Sodium Azide
formulation
Open stability: 90
days at 15-30°C
Wash Diluent 1 x 4 Deionized water and Same Same
Pack, 2500 ml each <0.05% Sodium Azide
Open stability: 60
days at 15-30°C
Use PIN 270-2730
(Wash/Diluent
Solution Set) to order


Export Only)
**NOTE: Bold text indicates a nomenclature difference only.

Calibrator vials 2 levels: 2 vials per Same Same

level
Lyophilized human
red cell hemolysate
with gentamycin,
tobramycin and
EDTA formulation**
Calibrator 7 mL of Calibrator Same Same
reconstitution volume Diluent
Deionized water** Same Same
Calibrator diluent
and <0.05% Sodium
Formulation
Azide
Calibrator 1 day at 2-8°C Same Same
reconstituted stability
Calibration frequency Once after installing Same Same
and priming a new
cartridge


Export Only)

Summary report Columns for Variant Same Same

and C
Blank samples used Quality control sample Same Same
in calibration and or patient sample
patient sample runs prediluted 1:300 with
Wash Diluent Note:
Do not use Calibrators
as blanks as there is
not adequate volume
Summary report Columns for Variant Same Same
and C
System As needed for Same Same
decontamination troubleshooting
procedure* 5 microvial of bleach.
5 microvials of DI
water
5 microvial of diluted
(1:10) patient whole
blood
* NOTE: Refer to the VARIANT™ II TURBO Operation Manual (L70241503 or later) for the
full procedure. .


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Technical Support Guide for the Use and Troubleshooting of the

The above content is for trained Bio-Rad personnel only

LB001293revB Technical Support Guide

Clinical Systems Division

Table of Contents Page

The above content is for trained Bio-Rad personnel only 2

The VARIANT™ II TURBO HbA1c Kit – 2.0, PIN 12000447, provides:

Indications for Use

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Table 1 - Kit Configuration Changes for the VARIANT™ II TURBO

Feature/Component VARIANT™ II TURBO HbA1c Kit -

Kit Name and PIN VARIANT™ II TURBO Hemoglobin A1c

Prefilter: 90 days post installation

The above content is for trained Bio-Rad personnel only 4

Table 1 - Kit Configuration Changes for the VARIANT™ II TURBO

Feature/Component VARIANT™ II TURBO HbA1c Kit -

The above content is for trained Bio-Rad personnel only 5

Table 1 - Kit Configuration Changes for the VARIANT™ II TURBO

Feature/Component VARIANT™ II TURBO HbA1c Kit -

Summary report Columns for Variant and C

Stability: Up to 7 days at 2-8°C or

Capillary blood collected in HCCS

HbF interference** HbA1c is reportable up to 25% HbF**

*NOTE: Refer to VARIANT™ II TURBO Hemoglobin Testing System Operation Manual

The above content is for trained Bio-Rad personnel only 6

Table 1 - Kit Configuration Changes for the VARIANT™ II TURBO

Performance Claims VARIANT II TURBO 2.0 (2500

NOTE: The homozygous and double-

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Table 2 – Individual Kit Component Availability for the VARIANT™ II

Cat No. Description Quantity Availability in SAP as

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Table 2 – Individual Kit Component Availability for the VARIANT™ II

Cat No. Description Quantity in Availability in SAP as

The above content is for trained Bio-Rad personnel only 9

Chromatography Differences, Report Layouts and Examples of Chromatograms

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Chromatography Differences, Report Layouts and Examples of Chromatograms

Figure 2: Diabetic sample on VARIANT™ II TURBO HbA1c Kit - 2.0

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Chromatography Differences, Report Layouts and Examples of Chromatograms

Figure 3: Elevated HbF on VARIANT™ II TURBO HbA1c Kit - 2.0

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Chromatography Differences, Report Layouts and Examples of Chromatograms

Figure 4: HbAE on VARIANT™ II TURBO HbA1c Kit - 2.0

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Chromatography Differences, Report Layouts and Examples of Chromatograms

Figure 5: HbAD on VARIANT™ II TURBO HbA1c Kit - 2.0

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Chromatography Differences, Report Layouts and Examples of Chromatograms

The above content is for trained Bio-Rad personnel only 15

Chromatography Differences, Report Layouts and Examples of Chromatograms

Figure 7: HbAC on VARIANT™ II TURBO HbA1c Kit - 2.0

The above content is for trained Bio-Rad personnel only 16

Chromatography Differences, Report Layouts and Examples of Chromatograms

The above content is for trained Bio-Rad personnel only 17

Chromatography Differences, Report Layouts and Examples of Chromatograms

Figure 9: Elevated Carbamylated Hemoglobin (CHb) on VARIANT™ II TURBO HbA1c

The above content is for trained Bio-Rad personnel only 18

Chromatography Differences, Report Layouts and Examples of Chromatograms

Figure 10: β-thalassemia trait sample.

HbF interference HbA1c is reportable up to 25% HbF