Roche Tina Quant Hba1C: Setting A New Precedent in Hba1C Lab Efficiency

Roche Tina Quant® HbA1c
Setting a new precedent in HbA1c lab efficiency

Indri Widyastuti
Product Manager Roche Diagnostics Indonesia
Diabetes Fact
Diabetes’s severity and its burden in healthcare & economics 1
High Prevalence High Expenditure High Undiagnosed ratio #7 Causes of Death

425 million adults have diabetes 727 billion USD is the cost of 212 million people have diabetes 4 million people died from
globally and the number will diabetes healthcare expenditure who were not well diagnosed, diabetes in 2017. Diabetes ranks
increase by 48% by 2045 globally, it will keep growing 50% have been undiagnosed #7 in global death causes
2 Rotkreuz | © 2018 Roche

Meet the Needs of Today’s Laboratory
New requirements for HbA1c testing in Diabetes Management
Lab TAT Testing Throughput
Operational Cost Workflow Efficiency
Clinical Decision Results Accuracy

Testing Throughput
We aim to provide most flexible
solution for our customers so that can
Workflow Efficiency
always find suitable product in any
phase along with their growing up…
Results Accuracy

HbA1c Market with 10+ Brands
Laboratories’ preference on brand in CAP survey 2
Cation Exchange Capillary Affinity Sebia
HPLC Electrophoresis Chromatography
Abbott 2% Trinity
8% 3%
BioRad
17%
D-100 G11 8180V Capillarys 3 Premier Hb9210 OCD
Variant II Turbo 2.0 G8 8160V Capillarys 2 Flex Piercing ultra 2 7%
Variant II Turbo G7
Variant II GX 7,557 results Tosoh
D-10 14%
Immuno Enzymatic Exclu. POC
Assays Assays
55% from IA
Arkray
1%
c 513 Adivia AU Vitros 5600 Atellica CH Architect c 8000 Siemens
c 503 Unicel Dxc Vitros 4600 Architect c 4000
Vista 21%
C 501/502 Dimension Alinity c
c 311 Roche
c 111 Beckman 20%
INT 400
7%
Immunoassay has been widely used on the HbA1c Market as well as HPLC

Enhance the Flexibility of Laboratory
7 platforms with throughput from 24 to 400 s/h to support laboratory
cobas c 111 analyzer cobas c 311 analyzer cobas c 501 module cobas c 502 module cobas INTEGRA® 400 cobas c 513 analyzer** cobas c 503 analyzer
400 s/h (only A1c)
24 s/h (only A1c) 38 s/h (only A1c) 75 s/h* (only A1c) 75 s/h* (only A1c) 80 s/h (only A1c) 400 s/h
Workflow Consolidation Workflow Consolidation
Dedicated A1c
Channel Filling A1c
HPLC Segmentation
Roche Segmentation
Low Volume Lab Mid Volume Lab High Volume Lab
* 75 samples/hour with SCCS
** not resgitered in Indonesia
Testing Throughput
We aim to simplify the process
and improve the efficiency to
Workflow Efficiency
reduce cost and create more value
for our customers…
Results Accuracy
7 Rotkreuz | © 2018 Roche WORKFLOW EFFICIENCY | DIRECT REPORT | SYSTEM ROBOSTNESS | DIGIAL SOLUTION | SAMPLE HANDLING | BEST PRACTICE
Direct Result Reporting
Time and expertise saved for more value
Results: alternative method 3 Results: Roche Tina Quant© HbA1c
Chromatogram Chromatogram
normal abnormal
Ready for reporting
Chromatogram same as chromatogram of a

common Hb variant? (HbAS, HbAC, HbAD, HbAE)
Yes No
Interference from Is the variant heterozygous

common Hb variant with (HbA present?
your HbA1c method?
Chance of reanalysis
or misinterpretation
Yes No
No Yes or ? Do not report HbA1c
HbA1c can Determine HbA1c with another method Reported in both IFCC units (mmol/mol)
be reported preferably affinity chromatography
and derived NGSP units (% HbA1c)
Robust to Sample Sedimentation
Sufficient immersion depth save time of sample pre-mixing
cobas c 501/502 cobas c 513
70% immersion depth
Pre-defined
immersion
depth
(tube specific; can be
changed by customer)
Robust to Sample Sedimentation
Stable results even after 24h of sedimentation
Roche cobas c 513 Sedimentation study with 24 samples in 24 hours
110
% change in recovery
105
100
95
90
1h 2h 3h 5h 8h 24 h
Time
Normal whole blood samples show stable Whole Blood samples do not require pre- Maximum observed change after 24 hours is
results for up to 24 hours mixing before placing on Roche analyzers 3%* compared to 1 hour results
No pre-mixing required by HbA1c on Roche system
Testing Throughput
We aim to lead the superior quality in
the market with innovation in order to
Workflow Efficiency
support laboratory diagnosis and
clinical decision making…
Results Accuracy
11 Rotkreuz | © 2018 Roche RESULT ACCURACY | PRINCIPE | VARIANT INTERFERENCE | CERTIFICATION | CORRELATION | SPECIFICATION | EQA | RCV
Roche Tina Quant® HbA1c Principle 5
Measurement of A1c as defined by IFCC
Photometric determination Turbidimetric determination of

of total hemoglobin antibody-polyhapten-complex
(Hb) (HbA1c)
Sample Hemolyze (Hb) Complex (HbA1c)

(continue reaction in formation
the same cuvette)
Total HbA1c
No enzymatic Total Hb Total HbA1c
hemolysis – this Total Hb
causes imprecision
HbA1c (% and SI units)
Patented Roche Tina Quant® HbA1c Antibody Epitope
High specificity without interference of common variants
Recognizes all major HbA1c variants
Tina-quant HbA1c Other immunoassay methods1

antibody epitope
26 121
HbA1c Gluc Val His Leu Thr Pro Glu Glu Glu Glu
HbS1c Gluc Val His Leu Thr Pro Val Glu Glu Glu
HbC1c Gluc Val His Leu Thr Pro Lys Glu Glu Glu
HbE1c Gluc Val His Leu Thr Pro Glu Glu Lys Glu
HbD1c Gluc Val His Leu Thr Pro Glu Glu Lys Gln
Overview of Common Variant Interferences
Tina-quant HbA1c is least susceptible to interferences 6
Method Hb C trait Hb S rait Hb E trait Hb D trait Other
Bio-Rad D10 (short) !
Bio-Rad D10 (extended)
Bio-Rad Variant II ! !
Bio-Rad Variant II Turbo 2.0 !
Menarini H8140 (Diabetis Mode) ! ! !
Menarini H8160 (Diabetis/Thal) ! !
Menarini H8180 * ! !
Tosoh G7 (Variant Analysis) ! !
Tosoh G8 (Variant Analysis) !
Roche Tina-quant Integra Gen.2 No interferences from known common variants
Roche Tina-quant Gen.2 & 3 No interferences from known common variants
Primus Boronate Affinity
Abbott Enzymatic HbA1c ! HbA2>5%
Effects on Common Variant Interferences
Not like HPLC, Roche not affected by the common variant
HbE, HbD Effect Study, 2008 7 Roche cobas c 513 MCE Study, 2016 8
Bias comparison of 23 methods HbE, HbD, HbS, HbC Interference
Effects of Rare Hb Variants on HbA1c Measurements
Roche is least interfered by 49 rare variants 9
49 rare variants on 8 Systems, interference observed with HPLC and Capillaris
Calibration-adjusted HbA1c results for rare Hb variant samples versus ultra2: Solid lines mark the equivalence (y = x); dashed lines indicate
the 99% prediction intervals based on comparisons of HbA1c values of AA samples. Open circles are results that would not be reported;
solid circles are results that would be reported;
Certification and Recognition
Complies with current guidelines and recommendations
cobas c 513
cobas c 513
cobas c 501/502
cobas c system
cobas c 311
cobas integra system
cobas c 111
cobas integra 400
IFCC Certificate NGSP Certificate

Traceability to IFCC reference method Traceability to DCCT study
Recognized expertise in Roche Tina Quant© HbA1c testing with Traceability

Dual reporting has been implemented for all instruments (mmol /mol and derived % HbA1c)
Certification and Recognition
Complies with CE and FDA diag. claim 10 criteria
Annual standardization
verification
Performance Data
Cleared Roche’s Intended Use (Diagnosis Claim):

Total error less than or
equal to 6%
Little to no interferences from

common Hb Variants
Correlations to Competitors’ Methods
Roche support your consistent patient Results
Roche c 513 vs. BioRad D-100 & VII 11 Roche c 513 vs. Tosoh G8 12 Roche c 513 vs. Arkray HA8180 12 Roche c 513 vs. Trinity Hb9210 13 Roche c 501 vs. Sebia Capillary 2 14
y = 1.01x-0.2094 y = 1. 03x+0.016
r = 0.9994 r = 0.9925
Excellent correlations to any on market methods with

standardization to IFCC
Testing Throughput
We aim to meet all of your needs
in HbA1c measurement in
Workflow Efficiency
diabetes management,
from first time and each time!
Results Accuracy

Doing now what patients need next

Thank you
for your attention
Find out more on

cobas.com
This presentation is our intellectual property. Without our written

consent, it shall neither be copied in any manner, nor used for
manufacturing, nor communicated to third parties.

Roche Tina Quant Hba1C: Setting A New Precedent in Hba1C Lab Efficiency

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Roche Tina Quant Hba1C: Setting A New Precedent in Hba1C Lab Efficiency

Uploaded by

Copyright:

Available Formats

Roche Tina Quant® HbA1c

Setting a new precedent in HbA1c lab efficiency

High Prevalence High Expenditure High Undiagnosed ratio #7 Causes of Death

2 Rotkreuz | © 2018 Roche

Lab TAT Testing Throughput

Operational Cost Workflow Efficiency

Clinical Decision Results Accuracy

3 Rotkreuz | © 2018 Roche

4 Rotkreuz | © 2018 Roche

5 Rotkreuz | © 2018 Roche

Results: alternative method 3 Results: Roche Tina Quant© HbA1c

Chromatogram same as chromatogram of a

Interference from Is the variant heterozygous

No Yes or ? Do not report HbA1c

cobas c 501/502 cobas c 513

70% immersion depth

Roche cobas c 513 Sedimentation study with 24 samples in 24 hours

No pre-mixing required by HbA1c on Roche system

Photometric determination Turbidimetric determination of

Sample Hemolyze (Hb) Complex (HbA1c)

Recognizes all major HbA1c variants

Tina-quant HbA1c Other immunoassay methods1

Abbott Enzymatic HbA1c ! HbA2>5%

49 rare variants on 8 Systems, interference observed with HPLC and Capillaris

IFCC Certificate NGSP Certificate

Recognized expertise in Roche Tina Quant© HbA1c testing with Traceability

Cleared Roche’s Intended Use (Diagnosis Claim):

Little to no interferences from

Excellent correlations to any on market methods with

20 Rotkreuz | © 2018 Roche

22 Rotkreuz | © 2018 Roche

Find out more on

This presentation is our intellectual property. Without our written

23 Rotkreuz | © 2018 Roche

You might also like