Endocrinology & Diabetes HbA1c

Glycated Hemoglobin (HbA1c).

Quantitative determination of glycated hemoglobin (HbA1c) from dried blood spot. Performed by high-performance liquid chromatography (HPLC) with ion exchange on a Bio-Rad D-10 system.

Quick Reference
Method
HPLC
Sample Types
DBS
Analytes

1 analyte (NGSP %)

Turnaround

3–5 working days

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What does this test assess?

This method enables accurate measurement of glycated hemoglobin A1c fraction from capillary blood collected on a dried blood spot card, providing a reliable indicator of average blood glucose levels over the preceding 2–3 months.

Clinical indications include:

  • Diagnosis of type 2 diabetes mellitus
  • Identification of patients at risk of developing diabetes (pre-diabetes)
  • Monitoring long-term glycaemic control in diabetic patients
  • Assessment of treatment efficacy and therapeutic adjustments
  • Population screening in remote or resource-limited settings via DBS
  • Epidemiological studies on diabetes prevalence

Measured analytes

Analyte / GroupComponentsClinical Significance
Hemoglobin A1c HbA1c (NGSP %) Glycated fraction of hemoglobin reflecting average blood glucose concentration over 2–3 months; used for diabetes diagnosis and glycaemic monitoring
Note

HbA1c is quantified from a single dried blood spot using HPLC with ion exchange, providing high specificity and robust performance. Results are reported as NGSP (%) values.

About HbA1c

Glycated hemoglobin (HbA1c) is formed by the non-enzymatic attachment of glucose to the N-terminal valine of the hemoglobin beta chain. Because red blood cells have an average lifespan of approximately 120 days, HbA1c provides a weighted average of blood glucose concentrations over the preceding 2–3 months, making it the gold-standard biomarker for long-term glycaemic control.

< 5.7%

Normal range (non-diabetic)

5.7 – 6.4%

Pre-diabetes (increased risk)

≥ 6.5%

Diagnostic threshold for diabetes

Unlike fasting glucose or oral glucose tolerance tests, HbA1c does not require fasting and is less affected by day-to-day variability, acute illness, or stress. This makes it particularly well-suited for population screening, especially when combined with DBS sampling for remote or at-home collection.

DBS advantage for HbA1c

Dried blood spot collection offers a significant practical advantage for HbA1c testing. A simple fingerprick sample collected on a TFN card (Ahlstrom-Munksjö) can be posted to the laboratory at ambient temperature, eliminating the need for venepuncture, cold-chain logistics, or clinic visits. This approach is especially valuable for remote monitoring of diabetic patients, large-scale screening programmes, and clinical trials.

Clinical applications
! Diabetes diagnosis (type 1 and type 2)
! Pre-diabetes risk identification
! Glycaemic control monitoring
! Treatment efficacy assessment
! Remote patient monitoring via DBS
! Epidemiological screening programmes

Analytical technique

Testing is performed using high-performance liquid chromatography (HPLC) with ion exchange on a Bio-Rad D-10 system. Capillary blood is collected on dried blood spot cards and the extract is analysed to determine the HbA1c fraction as a percentage (NGSP). The method has been clinically validated in-house with documented accuracy, precision, and method-comparison data against reference standards.

Sample information

This method is performed on dried blood spot (DBS) samples collected via fingerprick. Samples can be posted to the laboratory at ambient temperature, eliminating the need for venepuncture, cold-chain logistics, or clinic visits.

Testing process

From enquiry to results in a few simple steps — no clinic visit required.

1
Get in touch
Contact us to discuss your testing requirements
2
Collect your sample
Simple finger-prick onto a dried blood spot card — at home or in clinic
3
Post to our lab
DBS cards are stable at room temperature — ship by regular post worldwide
4
Receive results
Results delivered within 3–5 working days of sample receipt

Where this test is available

This test is available to healthcare professionals, wellness brands, clinics, and research institutions worldwide. We currently serve partners in:

  • Europe (EU & non-EU)
  • United Kingdom
  • Asia & Southeast Asia
  • Australia & New Zealand
  • United States

Whether you need testing services for your patients, white-label kits for your brand, or method transfer to your own laboratory — get in touch to discuss how we can work together.

Literature

  1. American Diabetes Association. “Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes.” Diabetes Care, 2024, 47(Suppl 1):S20-S42.
  2. Nathan DM, et al. “Translating the A1C assay into estimated average glucose values.” Diabetes Care, 2008, 31(8):1473-1478. 10.2337/dc08-0545
  3. World Health Organization. “Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus.” WHO, 2011.

Frequently Asked Questions

What is HbA1c?

HbA1c (glycated haemoglobin) is formed by the non-enzymatic attachment of glucose to haemoglobin in red blood cells. Because red blood cells have an average lifespan of approximately 120 days, HbA1c provides a weighted average of your blood glucose levels over the preceding 2 to 3 months. It is considered the gold standard biomarker for long-term glycaemic control and is used for both diagnosing and monitoring diabetes.

Why test HbA1c from a finger prick?

Testing HbA1c from a finger-prick dried blood spot eliminates the need for a clinic visit and venous blood draw. This is particularly useful for ongoing monitoring between GP appointments, for patients in remote areas, and for large-scale screening programmes. The DBS sample can be posted at room temperature without cold-chain logistics, making it a convenient and accessible option for regular diabetes monitoring.

How is the sample collected?

The test uses a simple finger-prick to collect a few drops of blood onto a dried blood spot (DBS) card. You can do this at home or in a clinic — no venous blood draw or fasting is required. The DBS card is stable at room temperature and can be posted to our laboratory by regular mail from anywhere in the world.

How long does it take to get results?

Results are typically delivered within 3 to 5 working days from the time your sample arrives at our laboratory. The analysis is performed by HPLC (high-performance liquid chromatography) with ion exchange on a Bio-Rad D-10 system, providing high specificity and robust performance for accurate HbA1c measurement.

What HbA1c level indicates diabetes?

An HbA1c below 5.7% (39 mmol/mol) is considered normal. A level between 5.7% and 6.4% (39 to 47 mmol/mol) indicates prediabetes, meaning increased risk of developing diabetes. An HbA1c of 6.5% (48 mmol/mol) or above on two separate tests is diagnostic for diabetes. These thresholds should always be interpreted by your healthcare provider in the context of your overall clinical picture.

Which countries is this test available in?

Masdiag's HbA1c test is available worldwide through our partner network. We currently serve healthcare professionals, wellness brands, and clinics in Europe, the United Kingdom, Asia, Australia, New Zealand, and the United States. Contact us to discuss testing services, white-label kits, or method transfer to your laboratory.

Interested in this method?

Whether you need testing services, method transfer, or white-label kit development — we'd love to hear from you.