An inaccurate test report may lead an unsuspecting clinician to make wrong patient
care decisions, causing delays in treatment, wrong prescriptions or even more dire
consequences. How can clinical laboratories avoid erroneous HbA1c results?
Clinically Misleading HbA1c Results
What causes spurious test results?
Deliver A1c Results with Confidence
Optimise your test quality performance
Why Bio-Rad A1c
Clinically Misleading HbA1c Results:
what causes them?
It is crucial to be aware of factors known to interfere with HbA1c test results when
using HbA1c to manage patients with diabetes. The table below provides an overview of
factors affecting clinical interpretation of HbA1c.
Factors that Interfere with HbA1c Test Results from
Published Sources
Aspirin (small doses)1,4,5; High doses of
vitamin C1,4,5 or vitamin E1,4,5; Certain hemoglobinopathies1
Chronic kidney disease5; Alcoholism1,5
Erythrocyte Life Span
Shortened erythrocyte life span1,3,5: Hemolytic
anemia2,3,6; Splenomegaly1,5;
Rheumatoid arthritis1; Nephritis3;
Liver
Disease3; Sepsis3;
Certain hemoglobinopathies1; Paroxysmal nocturnal
hemoglobinuria3; Drugs such as antiretrovirals1,4,5, ribavirin1,4 and
dapsone1,4
Increased erythrocyte life span1,5,6:
Splenectomy1,5,6
Analytical Factors
Assay Method Interference
Hypertriglyceridaemia1,5; Certain
hemoglobinopathies1,5
Hyperbilirubinaemia1,5; Carbamylated
hemoglobin1; Certain
hemoglobinopathies1,5; Chronic opiate
usage1,4
Reference: 1. Geneva: World Health Organization 2011, Use of Glycated Haemoglobin
(HbA1c) in the Diagnosis of Diabetes Mellitus: Abbreviated Report of a WHO
Consultation, viewed 29 April 2021,
https://www.ncbi.nlm.nih.gov/books/NBK304263/?report
2. NGSP 2019, Factors that Interfere with HbA1c Test Results, viewed 19
May 2021, http://www.ngsp.org/factors.asp
3. Lohmann, T.P 2019, The impact of red blood cell lifespan on HbA1c
measurement, viewed 20 May 2021,
https://www.mlo-online.com/disease/diabetes/article/21085264/the-impact-of-red-blood-cell-lifespan-on-hba1c-measurement
4. Unnikrishnan, Ranjit & Anjana, Ranjit & Mohan, Viswanathan. (2012).
Drugs affecting HbA1c levels. Indian journal of endocrinology and
metabolism. 16. 528-31. 10.4103/2230-8210.98004.
5. Goel, Shobhit & Sen, Arijit & Sampath, Sangeetha & Tripathi, Preeti.
(2020). Hemoglobin E: a potential interferent in measurement of glycated
hemoglobin. International Journal of Advances in Medicine. 7.
10.18203/2349-3933.ijam20203609.
6. O'keeffe, D., Maraka, S., & Rizza, R. (2016). HbA1c in the Evaluation
of Diabetes Mellitus. JAMA, 315 6, 605-6. 10.1001/jama.2015.16561.
7. Garza, M. 2020, Your A1C May Not Be Reliable If You Have Chronic
Kidney Disease, viewed 29 July 2021,
https://diatribe.org/your-a1c-may-not-be-reliable-if-you-have-chronic-kidney-disease
While many of the above conditions altering red cell production, red cell life span and
rate of glycation can be picked up by a review of the patient's medical record or prior
laboratory results, conditions which are clinically silent, like hemoglobinopathies
which is highly prevalent across Asia, can be missed, resulting in wrong patient care
decisions, and treatment delays.
The use of a HbA1c assay method that reveals suspected hemoglobin variants (otherwise
invisible on other methods) can help you identify patients with clinically silent
hemoglobinopathies, allowing you to alert Physicians of potential interference on
HbA1c test results and/or suggest other methods to manage patients with
hemoglobinopathies.
Hemoglobin variants in Asia Pacific
The Asia Pacific region is known for its diverse population and a high prevalence of hemoglobinopathies
and hemoglobin variants.
The HbA1c test is based on normal hemoglobin, and as such hemoglobinopathies and hemoglobin variants can
affect the reliability of the HbA1c test in three ways as illustrated in the table above (Factors that
Interfere with HbA1c Test Results from Published Sources):
Altering the normal process of glycation of HbA to HbA1c, and/ or
Altering the erythrocyte life span -- increasing or decreasing the time for glycosylation to occur,
and/ or
Anping Xu, Weidong Chen, Weijie Xie, Ling Ji, Yuhui Wang, Miao Xu. A New α Chain Variant, Hb Heilongjiang
(HBA2: c.49A>C), Found During Hb A1c Measurement. Hemoglobin. 2020; 44:2, 143-145, DOI:
10.1080/03630269.2020.1766487
Jiang F, Xu LL, Chen GL, Zhou JY, Li J, Tang XW, Zuo LD, Li DZ. Hematological Characteristics of Hb
Constant Spring (HBA2: c.427T>C) Carriers in Mainland China. Hemoglobin. 2020 Mar;44(2):86-88. doi:
10.1080/03630269.2020.1755979. Epub 2020 Apr 27. PMID: 32338097.
Jo I, Jang W, Chae H, Kim SY, Kim M, Kim Y, Han K. Hemoglobin Kansas: First Korean Family and Literature
Review. Ann Lab Med. 2017 Jul;37(4):352-354. doi: 10.3343/alm.2017.37.4.352. PMID: 28445020; PMCID:
PMC5409020.
Lau YL, Chan LC, Chan YY, Ha SY, Yeung CY, Waye JS, Chui DH. Prevalence and genotypes of alpha- and
beta-thalassemia carriers in Hong Kong -- implications for population screening. N Engl J Med. 1997 May
1;336(18):1298-301. doi: 10.1056/NEJM199705013361805. PMID: 9113933.
Lee ST, Kim MS, Choi DY, Kim SK, Ki CS. Incidence of variant hemoglobin (Hb) and increased fetal Hb
concentrations and their effect on Hb A1c measurement in a Korean population. Clin Chem. 2006
Jul;52(7):1445-6. doi: 10.1373/clinchem.2006.069617. PMID: 16798979.
Wang PP, Lin M, Wu JR, Wang XY, Yang LY. Three cases of the hemoglobin G-Chinese variant detected in
patients of southern Chinese origin. Mol Med Rep. 2010 May-Jun;3(3):459-61. doi: 10.3892/mmr_00000280. PMID:
21472262.
Xu A, Chen W, Xia Y, Zhou Y, Ji L. Effects of common hemoglobin variants on HbA1c measurements in China:
results for α- and β-globin variants measured by six methods. Clin Chem Lab Med. 2018 Jul
26;56(8):1353-1361. doi: 10.1515/cclm-2017-1211. PMID: 29626415.
Xu A, Chen W, Xu M, Xie W, Ji L. Identification of Hemoglobin Variants Prevalent in China and Their
Effects on Hemoglobin A1c Measurements. Am J Clin Pathol. 2022 Jun 7;157(6):852-857. doi:
10.1093/ajcp/aqab196. PMID: 34871348.
Would you like to know HOW hemoglobinopathies and hemoglobin variants can affect
HbA1c results on different HbA1c test methods?
Bio-Rad A1c Experts explain the effects of
hemoglobinopathies
and hemoglobin variants on various HbA1c test methods:
Ai S, Cliffe C, Kidson-Gerber G. Antenatal haemoglobinopathy screening - Experiences of a large Australian
Centre. Obstet Med. 2021 Jun;14(2):89-94. doi: 10.1177/1753495X20944708. Epub 2020 Aug 19. PMID: 34394717;
PMCID: PMC8358238.
Would you like to know HOW hemoglobinopathies and hemoglobin variants can affect
HbA1c results on different HbA1c test methods?
Bio-Rad A1c Experts explain the effects of
hemoglobinopathies and hemoglobin variants on various HbA1c test methods:
Brennan SO, Ryken S, Chan T. Hb Koya Dora [alpha142, Term-->Ser (TAA>TCA in alpha2)]: a rare
mutation of the alpha2 gene stop codon associated with alpha-thalassemia. Hemoglobin. 2010;34(4):402-5. doi:
10.3109/03630269.2010.486344. PMID: 20642339.
Chowdhury MA, Sultana R, Das D. Thalassemia in Asia 2021 Overview of Thalassemia and Hemoglobinopathies in
Bangladesh. Hemoglobin. 2022 Jan;46(1):7-9. doi: 10.1080/03630269.2021.2008957. PMID: 35950585.
Mondal SK, Mandal S. Prevalence of thalassemia and hemoglobinopathy in eastern India: A 10-year
high-performance liquid chromatography study of 119,336 cases. Asian J Transfus Sci. 2016
Jan-Jun;10(1):105-10. doi: 10.4103/0973-6247.175424. PMID: 27011683; PMCID: PMC4782486.
Unnikrishnan R, Mohan V. Challenges in estimation of glycated hemoglobin in India. Diabetes Technol Ther.
2013 Oct;15(10):897-9. doi: 10.1089/dia.2013.0144. Epub 2013 Aug 14. PMID: 23944907; PMCID: PMC3781113.
Would you like to know HOW hemoglobinopathies and hemoglobin variants can affect
HbA1c results on different HbA1c test methods?
Bio-Rad A1c Experts explain the effects of
hemoglobinopathies and hemoglobin variants on various HbA1c test methods:
Chinchang W, Viprakasit V. Further identification of Hb G-Coushatta [beta22(B4)Glu-->Ala
(GAA-->GCA)] in Thailand by the polymerase chain reaction-single-strand conformation polymorphism
technique and by amplification refractory mutation system-polymerase chain reaction. Hemoglobin.
2007;31(1):93-9. doi: 10.1080/03630260601059225. PMID: 17365010.
Chakraborty S, Chanda D, Gain M, Krishnan P. Interference of the Hope Hemoglobin With Hemoglobin A1c
Results. Lab Med. 2015 Summer;46(3):221-5. doi: 10.1309/LME82XNY6SYVWDYQ. PMID: 26199262.
Chowdhury MA, Sultana R, Das D. Thalassemia in Asia 2021 Overview of Thalassemia and Hemoglobinopathies in
Bangladesh. Hemoglobin. 2022 Jan;46(1):7-9. doi: 10.1080/03630269.2021.2008957. PMID: 35950585.
Fucharoen S, Winichagoon P. Haemoglobinopathies in southeast Asia. Indian J Med Res. 2011
Oct;134(4):498-506. PMID: 22089614; PMCID: PMC3237250.
Mitchai M, Suwansaksri N, Seanseeha S, Saenboonsiri J, Kraitree P, Piyapromdee J, Silsirivanit A.
Misleading HbA1c Measurement in Diabetic Patients with Hemoglobin Variants. Med. Sci. 2021; 9(2):43.
doi.org/10.3390/medsci9020043.
Munkongdee T, Tanakulmas J, Butthep P, Winichagoon P, Main B, Yiannakis M, George J, Devenish R, Fucharoen
S, Svasti S. Molecular Epidemiology of Hemoglobinopathies in Cambodia. Hemoglobin. 2016 Jun;40(3):163-7.
doi: 10.3109/03630269.2016.1158723. PMID: 27117566.
Ne-Win, Harano K, Harano T, Kyaw-Shwe, Aye-Aye-Myint, Khin-Thander-Aye, Okada S. Hb Constant Spring [alpha
142, Term-->Gln (TAA>CAA in alpha2)] in the alpha-thalassemia of anemic patients in Myanmar.
Hemoglobin. 2008;32(5):454-61. doi: 10.1080/03630260802341588. PMID: 18932070.
Phengsavanh A, Sengchanh S, Souksakhone C, Souvanlasy B, Sychareun V. Current Status of Thalassemia in Lao
People's Democratic Republic. Hemoglobin. 2022 Jan;46(1):58-61. doi: 10.1080/03630269.2022.2069034. PMID:
35950579.
Would you like to know HOW hemoglobinopathies and hemoglobin variants can affect
HbA1c results on different HbA1c test methods? Bio-Rad A1c Experts explain the effects of
hemoglobinopathies and hemoglobin variants on various HbA1c test methods:
References
1. Ai S, Cliffe C, Kidson-Gerber G. Antenatal haemoglobinopathy screening - Experiences of a large Australian
Centre. Obstet Med. 2021 Jun;14(2):89-94. doi: 10.1177/1753495X20944708. Epub 2020 Aug 19. PMID: 34394717; PMCID:
PMC8358238.
2. Anping Xu, Weidong Chen, Weijie Xie, Ling Ji, Yuhui Wang, Miao Xu. A New α Chain Variant, Hb Heilongjiang
(HBA2: c.49A>C), Found During Hb A1c Measurement. Hemoglobin. 2020; 44:2, 143-145, DOI:
10.1080/03630269.2020.1766487
3. Brennan SO, Ryken S, Chan T. Hb Koya Dora [alpha142, Term-->Ser (TAA>TCA in alpha2)]: a rare mutation of
the alpha2 gene stop codon associated with alpha-thalassemia. Hemoglobin. 2010;34(4):402-5. doi:
10.3109/03630269.2010.486344. PMID: 20642339.
4. Chakraborty S, Chanda D, Gain M, Krishnan P. Interference of the Hope Hemoglobin With Hemoglobin A1c Results.
Lab Med. 2015 Summer;46(3):221-5. doi: 10.1309/LME82XNY6SYVWDYQ. PMID: 26199262.
5. Chinchang W, Viprakasit V. Further identification of Hb G-Coushatta [beta22(B4)Glu-->Ala (GAA-->GCA)] in
Thailand by the polymerase chain reaction-single-strand conformation polymorphism technique and by amplification
refractory mutation system-polymerase chain reaction. Hemoglobin. 2007;31(1):93-9. doi: 10.1080/03630260601059225.
PMID: 17365010.
6. Chowdhury MA, Sultana R, Das D. Thalassemia in Asia 2021 Overview of Thalassemia and Hemoglobinopathies in
Bangladesh. Hemoglobin. 2022 Jan;46(1):7-9. doi: 10.1080/03630269.2021.2008957. PMID: 35950585.
7. Fucharoen S, Winichagoon P. Haemoglobinopathies in southeast Asia. Indian J Med Res. 2011 Oct;134(4):498-506.
PMID: 22089614; PMCID: PMC3237250.
8. Jiang F, Xu LL, Chen GL, Zhou JY, Li J, Tang XW, Zuo LD, Li DZ. Hematological Characteristics of Hb Constant
Spring (HBA2: c.427T>C) Carriers in Mainland China. Hemoglobin. 2020 Mar;44(2):86-88. doi:
10.1080/03630269.2020.1755979. Epub 2020 Apr 27. PMID: 32338097.
9. Jo I, Jang W, Chae H, Kim SY, Kim M, Kim Y, Han K. Hemoglobin Kansas: First Korean Family and Literature
Review. Ann Lab Med. 2017 Jul;37(4):352-354. doi: 10.3343/alm.2017.37.4.352. PMID: 28445020; PMCID:
PMC5409020.
10. Lau YL, Chan LC, Chan YY, Ha SY, Yeung CY, Waye JS, Chui DH. Prevalence and genotypes of alpha- and
beta-thalassemia carriers in Hong Kong -- implications for population screening. N Engl J Med. 1997 May
1;336(18):1298-301. doi: 10.1056/NEJM199705013361805. PMID: 9113933.
11. Lee ST, Kim MS, Choi DY, Kim SK, Ki CS. Incidence of variant hemoglobin (Hb) and increased fetal Hb
concentrations and their effect on Hb A1c measurement in a Korean population. Clin Chem. 2006 Jul;52(7):1445-6.
doi: 10.1373/clinchem.2006.069617. PMID: 16798979.
12. Mitchai M, Suwansaksri N, Seanseeha S, Saenboonsiri J, Kraitree P, Piyapromdee J, Silsirivanit A. Misleading
HbA1c Measurement in Diabetic Patients with Hemoglobin Variants. Med. Sci. 2021; 9(2):43.
doi.org/10.3390/medsci9020043.
13. Mondal SK, Mandal S. Prevalence of thalassemia and hemoglobinopathy in eastern India: A 10-year
high-performance liquid chromatography study of 119,336 cases. Asian J Transfus Sci. 2016 Jan-Jun;10(1):105-10.
doi: 10.4103/0973-6247.175424. PMID: 27011683; PMCID: PMC4782486.
14. Munkongdee T, Tanakulmas J, Butthep P, Winichagoon P, Main B, Yiannakis M, George J, Devenish R, Fucharoen S,
Svasti S. Molecular Epidemiology of Hemoglobinopathies in Cambodia. Hemoglobin. 2016 Jun;40(3):163-7. doi:
10.3109/03630269.2016.1158723. PMID: 27117566.
16. Ne-Win, Harano K, Harano T, Kyaw-Shwe, Aye-Aye-Myint, Khin-Thander-Aye, Okada S. Hb Constant Spring [alpha
142, Term-->Gln (TAA>CAA in alpha2)] in the alpha-thalassemia of anemic patients in Myanmar. Hemoglobin.
2008;32(5):454-61. doi: 10.1080/03630260802341588. PMID: 18932070.
17. Phengsavanh A, Sengchanh S, Souksakhone C, Souvanlasy B, Sychareun V. Current Status of Thalassemia in Lao
People's Democratic Republic. Hemoglobin. 2022 Jan;46(1):58-61. doi: 10.1080/03630269.2022.2069034. PMID:
35950579.
18. Unnikrishnan R, Mohan V. Challenges in estimation of glycated hemoglobin in India. Diabetes Technol Ther. 2013
Oct;15(10):897-9. doi: 10.1089/dia.2013.0144. Epub 2013 Aug 14. PMID: 23944907; PMCID: PMC3781113.
19. Wang PP, Lin M, Wu JR, Wang XY, Yang LY. Three cases of the hemoglobin G-Chinese variant detected in patients
of southern Chinese origin. Mol Med Rep. 2010 May-Jun;3(3):459-61. doi: 10.3892/mmr_00000280. PMID: 21472262.
20. Xu A, Chen W, Xia Y, Zhou Y, Ji L. Effects of common hemoglobin variants on HbA1c measurements in China:
results for α- and β-globin variants measured by six methods. Clin Chem Lab Med. 2018 Jul 26;56(8):1353-1361. doi:
10.1515/cclm-2017-1211. PMID: 29626415.
21. Xu A, Chen W, Xu M, Xie W, Ji L. Identification of Hemoglobin Variants Prevalent in China and Their Effects on
Hemoglobin A1c Measurements. Am J Clin Pathol. 2022 Jun 7;157(6):852-857. doi: 10.1093/ajcp/aqab196. PMID:
34871348.
Please fill in the form to get your customised Hb Variants resource pack.
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Deliver A1c results
with confidence
Not all HbA1c Methods Are Created
Equal
HPLC (High Performance Liquid Chromatography) results provide more
than just a number. HPLC separates HbA1c and other hemoglobin based
on their differing charges. Separation of different hemoglobin
fractions reveals suspected hemoglobin variants which may interfere
with HbA1c results. Seeing suspected hemoglobin variants helps you
generate quality HbA1c results, reducing time wasted on
investigating questionable results. That is why 62% of
NGSP-certified labs choose the HPLC technology
today5 .
How Do You Know What Your System Doesn't Show?
Learn more about hemoglobin testing with HPLC to get the full
patient picture.
Add An Independent, Unbiased
Assessment To Your Test Regime
The addition of an unbiased assessment – one that is not optimized
for a particular platform – is an immediate, impactful improvement
you can make to your laboratory workflow to uncover any performance
issues leading to inaccurate test results. These may include:
Reagent or calibrator reformulation
Standardization adjustment
Instrument software changes
The cost of including an independent control to your current QC
regime greatly outweighs the cost of poor quality control –
incorrect patient care decisions from false positives or negatives
being the greatest cost of all.
Independent quality controls help streamline workflows, reduce
errors, maintain compliance, and facilitate accreditation—improving
efficiency and saving money. More multi-analyte controls allow for
consolidation across suppliers while human-based materials better
mimic patient samples.
Want to find out more about independent controls? Bio-Rad
Liquichek/Lyphocheck Diabetes Controls are human whole blood-based
independent controls enabling unbiased assessment of your A1c
performance. Let us help.
Greater Confidence in Patient Results
300+
quality control products
500+
comprehensive analytes
1000+
assays
Up to 48
months shelf life
Participate in An EQAS Program
External Quality Assurance Services (EQAS) programs are used to
periodically assess the quality of a lab’s performance and achieve
added confidence in patient test results. Results are objectively
compared to other laboratories using the same methodologies,
instruments, and reagents. Evaluations help initiate process to
identify sources of error across all the analytic testing phases and
can be used to evaluate both staff and assay performances.
External Quality Assessment is part of the requirements for ISO
standard 15189 certification
Provides an independent, confidential direct accuracy evaluation
on a monthly basis
The EQAS Hemoglobin Program provides NGSP Target value of HbA1c
Want to find out more about our EQAS program? Let us help.
Benefits of EQAS Programs
Full accreditation helps increase reliability and
solidifies our commitment to quality
Comprehensive, easy-to-read reports help streamline
workflow
Similar to patient samples at clinically relevant
levels
Two electronic reporting options, EQAS Online and EQAS
Mobile, add convenience
Comprehensive analyte menus offer wide range of tests
for clinical labs and blood banks
Technical support from experienced professionals adds
confidence
Perform Linearity At Least Once
Every 6 Months
Linearity is a fundamental characteristic of many analytic
measurement methods, whereby there is a straight-line relationship
between "true" analyte concentrations and measured concentrations.
For most assays, this relationship is linear within the AMR
(Analytical Measuring Range). Verification of the AMR is performed
at least every six months after a method has been placed in service
or any of the following occur:
When reagent lot changes
When there is an unusual QC trend occuring outside acceptable
limits and the system cannot be corrected to bring QC values
into acceptable range
After a major preventive maintenance or change of a critical
instrument component
When recommend by the manufacturer
Hemoglobin A1c Linearity Controls for Diabetes Testing
Bio-Rad offers a human whole blood-based control designed to verify
linearity throughout the assay reportable range of HbA1c test
methods.
Comprehensive diabetes and linearity analytes enhance
testing capability
Variety of configurations add convenience
Available for most major manufacturers’ analyzers
Monitor precision at clinically relevant ranges
Long shelf lives reduce labor and save money
Unity software offers large peer group for improved
test performance
HbA1c in Diabetes Care and Management: Demysifying the Unknowns
Commentary Paper by Dr.Richard Pang, PhD, FAACC,
Consultant – Total Laboratory Quality
The HbA1c Results From Your Lab Affect Clinical Decisions.
A bad result is worse than no result. An inaccurate test report may lead an
unsuspecting clinician to make wrong patient care decisions, causing delays in
treatment, wrong prescriptions or even more dire consequences.
What do you consider when selecting an HbA1c analyzer
for your laboratory?
Not all HbA1c methods are created equal. HPLC methods provide information on interference from
hemoglobin variants in addition to HbA1c readings6.
Choose the HPLC method.
Dr. Richard Pang, a former Scientific Officer at the Department of Pathology and
Clinical Biochemistry in Queen Mary Hospital, Hong Kong, and Fellow of AACC, shares
his thoughts about the challenges in interpreting HbA1c results, the advantage of
using HPLC method for HbA1c testing and how HPLC helps provide a higher level of
confidence when releasing results.
Disclaimer: This is not to promote any product. This is only for HCP education on HbA1c.
Why Bio-Rad A1c
Bio-Rad Laboratories is the world’s leading specialty diagnostics company.
Our mission is to advance scientific discovery to improve
healthcare. Our products are recognized as the gold standard for
diabetes testing, hemoglobinopathy screening, and quality control systems. We
have also played a leading role in the advancement of scientific discovery by
providing tools and services to the life science research and clinical
diagnostics markets. Since 1952, we have served more than 85,000 research,
industry, and clinical laboratories across the globe.
World leader and gold standard in
delivering high-quality HbA1c testing systems.
The Bio-Rad ion-exchange high performance liquid chromatography is
the gold standard for A1c testing. Its HPLC
technology played a key role in the Diabetes Control and
Complications Trial1,2 and the UK Prospective
Diabetes Study3 .
Healthcare providers around the world follow the A1c
testing guidelines, established by these landmark trials, to aid in
the diagnosis and monitoring of patients living with diabetes.
No other commercial method or HPLC system can make this
claim.
A1c results your clinicians can
trust.
Our technology is backed by over 40 years of research in
diabetes, hemoglobinopathies, and beta thalassemia. Our A1c
diagnostic tests are run on hemoglobin testing systems that are NGSP
certified, IFCC traceable, and standardized to DCCT as recommended
by the American Diabetes Association4 . In fact,
more NGSP-certified labs are powered by Bio-Rad ion-exchange HPLC
than any other system or method. In addition, our assays are CE
marked and FDA cleared.
More NGSP-certified
labs5 are powered by Bio-Rad A1c
The purpose of the NGSP is to standardize Hemoglobin A1c test results
to those of the Diabetes Control and Complications Trial (DCCT) and
United Kingdom Prospective Diabetes Study (UKPDS) which established
the direct relationships between HbA1c levels and outcome risks in
patients with diabetes.
NGSP certification demonstrates DCCT and UKPDS traceability
62% of total NGSP-certified labs* worldwide trust HPLC for A1c
testing, out of which 63% trust Bio-Rad HPLC
* Some labs have more than one certified instrument.
Our commitment to
quality HbA1c results
Our commitment of support
Quality patient care is at the heart of what you do and the reason why we are constantly
working to ensure that our products, services, cybersecurity applications, and
educational tools meet your needs. No matter the continent, country, or city, Bio-Rad
offers support that you can depend on.
We take care of your instrument, while you focus on your business
BRiCare™ is Bio-Rad’s instrument monitoring application for the highest level of
remote service and support. With BRiCare™, we can rapidly troubleshoot and solve
problems, and can proactively identify developing problems before
they occur. BRiCare™ increases instrument availability and reduces response time to
customer calls. Software configuration problems can be solved immediately in
remote sessions, and most other problems can be analyzed remotely so that they
are solved on the first visit.
We take Cybersecurity seriously
Rest assured, your laboratory and testing systems are protected. The AppLocker
utility locks down your system software configuration so only known and approved
programs can be executed. Our optional artificial intelligence-driven BlackBerry®
Protect antivirus software defends against online threats.
We partner you to achieve your quality goals
We help laboratories improve the reliability of their HbA1c results by providing
onboard QC modules which easily integrate into your laboratory’s quality management
program. We also offer unparalleled quality control expertise, services, and
supplemental human whole blood-based QC products such as independent controls,
External Quality Assurance Services (EQAS) programs, Hemoglobin A1c Linearity
Controls, and QC data management solutions to help you achieve your HbA1c quality
goals.
We develop educational tools to support you
Bio-Rad understands how important it is to identify hemoglobin variants that could
interfere with the accuracy of your HbA1c result. As the leader in
hemglobinopathies, we developed the Library of Variants, an educational tool and
reference database of over 200 confirmed hemoglobinopathy cases to support your
laboratory. We also developed the Digital Library of on-demand educational webinars,
as well as a Test Your Knowledge Educational Program consisting of hemoglobinopathy
case studies.
Be the difference for clinicians and patients who
count on you
Your clinicians depend on HbA1c results that help provide accurate treatments. That is
why we are committed to quality products and reliable results to help improve patient
outcomes. We are dedicated to helping you be the difference for your clinicians and
their patients. Like you and your clinicians, we believe that missing one diagnosis is
one too many.
Speak with a Bio‑Rad Specialist to tailor a solution for your
laboratory
Thank you for filling out the form!
We will be in contact with you soon.
References 1. DCCT Research Group (1996). The absence of a glycemic threshold for the development of
long-term complications: the perspective of the Diabetes Control and Complications Trial. Diabetes
45(10), 1289–1298.
2. Nathan DM et al. (1993). The effect of intensive treatment of diabetes on the development and
progression of long-term complications in insulin-dependent diabetes mellitus. The New England
Journal of Medicine 329(14), 977–986. Retrieved from doi.org/10.1056/NEJM199309303291401.
3. U.K. Prospective Diabetes Study (UKPDS) Group (1998). Intensive blood-glucose control with
sulphonylureas or insulin compared with conventional treatment and risk of complications in patients
with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 352:837-53.
4. American Diabetes Association (2020). Pharmacologic Approaches to Glycemic Treatment:
Standards of Medical Care in Diabetes—2020. Diabetes Care 43(Supplement 1): S98-S110. Retrieved from
doi.org/10.2337/dc20-S009.
5. NGSP. (March 2021). List of NGSP Certified Laboratories. Retrieved from
http://www.ngsp.org/docs/labs.pdf.
6. Weykamp C. HbA1c: A Review of Analytical and Clinical Aspects. Ann Lab Med 2013;33:393-400.
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