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Diabetes (HbA1c) Test Service

Diabetes (HbA1c) Test Service

MyHealthTest’s fingerprick blood test was developed by researchers from the Australian National University and aims to improve the access and convenience of blood testing for chronic conditions.

Their study published in BMC Clinical Pathology in 2015 found comparable results between the MyHealthTest Diabetes HbA1c dried blood spot test and traditional whole blood testing.

This work was also accepted at the 2015 ADS/ADEA Annual Scientific Meeting where the following poster was presented: Time-dependent effects of HbA1c levels measured through dried blood spot sampling.

The dried blood spot HbA1c test results showed a high correlation and comparable precision to conventional whole blood HbA1c test results, demonstrating that dried blood spot HbA1c testing is a viable, accurate alternative to traditional pathology methods. With imprecision <3%, dried blood spot testing is superior to many point of care HbA1c testing units.



Table 1 – Characteristics of the studied population

AllNo diabetesType 1 diabetesType 2 diabetes
Gender (Males:Females)51 M : 64 F20 M : 28 F2 M : 9 F28 M : 28 F
Age (years; mean ± SD)55.9 ± 15.346.2 ± 14.445.0 ± 12.864.8 ± 10.0
WB HbA1c (%; mean ± SD)6.22 ± 1.11%5.41 ± 0.35%7.80 ± 0.81%6.61 ± 1.11%

Note: WB = whole blood; SD = standard deviation





Bland-Altman plots of capillary dried blood spot samples from days 0, 4, 7 and 14. Dashed lines represent 95 % limits of agreement; full lines represent biases. WB = whole blood on D0; cap = capillary; DBS = dried blood spot. MyHealthTest accept DBS samples up to 11 days after sample collection.



Measurement Range:
4-15% NGSP
20-140 mmol/mol IFCC
(at a normal haemoglobin (Hb) concentration of 9.3 mmol/l)
Reference Interval:
≥6.5% (48 mmol/mol) May have diabetes
6.0 – 6.4% (42-47 mmol/mol)    At risk of developing diabetes
<6.0% (42 mmol/mol) Diabetes not currently likely
Accuracy (bias):Positive bias <0.4% HbA1c NGSP
Repeatability:Average 1% and >97% of the time is <3%
Reproducibility:Average at 1.8%
Stability: ≤11 days

Testing has shown that after holding dried blood spot samples at 46°C for 2 days there is a slight increase in the HbA1c level from people with an HbA1c of 7.5% and higher. Therefore, there may be a small variation in results if samples are subjected to extreme temperature conditions.

Interferences:

Individuals with an iron deficiency anemia may give high HbA1c mmol/mol.

Individuals with haemolytic disease or other conditions with shortened red blood cell survival may exhibit a substantial reduction in HbA1c.

Samples containing high amounts of glycated fetal haemoglobin (HbF) >10% may result in lower HbA1c values than expected.



HbA1c and diabetes diagnosis

Glycated haemoglobin, or HbA1c, is commonly measured in the management of diabetes. The test has more recently been endorsed as a diagnostic test for Type 2 diabetes by the World Health Organisation, the International Diabetes Federation and by an Australian Diabetes Society expert committee. These recommendations have been outlined in a 2012 article published in the Medical Journal of Australia.

HbA1c has now been approved for the diagnosis of diabetes in Australia.

More information: