BiossaysTM HbA1c
Biochemistry Assay
Accuracy · Cost-effective · Automatic
Product Benefits
● Two reagents only:
Saving manual mixing of reagents preparation avoids random errors, providing a convenient user experience.
Longer stability compared to commercially available kits packaged with 3 reagents.
● The high throughput BiossaysTM biochemistry platform ensures cost-effective solutions for clinicians.
● HbA1c Characteristics:
Reflect average blood glucose levels, providing a useful longer-term gauge of blood glucose control.
Sample can be obtained any time of the day, HbA1c is stable in the sample.
Predicts the development of complications of diabetes, used to guide treatment.
● Traceable and standardized to the NGSP certification.
(BiossaysTM 240 Plus, BiossaysTM 1200, Biolumi® 8000)
Clinical Background 422 million peopel worldwide have diabetes,
particularly in low-and middle-income countries.
HbA1c is a form of hemoglobin (Hb) that is chemically linked to WHAT PARTS OF YOUR BODY CAN BE
glucose. HbA1c is a measure of the beta-N-1-deoxy fructosyl AFFECTED BY DIABETES?
component of hemoglobin.
It is measured primarily to determine the three-month average Nervous System
blood glucose level and can be used as a diagnostic test for
diabetes mellitus and as an assessment test for glycemic Eyes, Teeth & Gums
control in people with diabetes [1].
Coronary Arteries
Diabetes is a chronic, metabolic disease characterized by
elevated levels of blood glucose (or blood sugar), which leads Kidneys
over time to serious damage to the heart, blood vessels, eyes,
kidneys, and nerves. Blood Vessels
Feet & Skin
Clinical Application Table 1. HbA1c as an indicator of diabetes control [3].
BLOOD GLUCOSE STATUS HbA1c
mmol/L mg/dL % mmol/mol
Monitoring glycemic status 5.4 97
Normal
5 31
7.0 126 6 42
The routine monitoring of long-term glycemic status in both type I and 8.6 155 Pre-Diabetes 7 53
type II diabetes patients. 10.2 184 Diabetes 8 64
11.8 212 9 75
The index of mean glycemia and as such, documents the degree of 13.4 241
Diabetes
10 86
glycemic control, response to therapy, and risk for developing or 14.9 268 11 97
Diabetes
worsening diabetes complications [2]. 16.5 297 12 108
Diagnosis for diabetes mellitus
The WHO recommends HbA1c can be used as a diagnostic test for diabetes.
An HbA1c of 6.5% is recommended as the cut point for diagnosing diabetes. A value less than 6.5% does not
exclude diabetes diagnosed using glucose tests [4].
Glycemic control in pregnancy
HbA1c measurements during pregnancy in patients with diabetes to determine the minimal perinatal risk for the
mother and maximum health of the fetus.
Stringent control before and during pregnancy decreases the risk of congenital malformations, overweight infants,
as well as complications of pregnancy and delivery related to poorly managed glycemic control [3].
Management of chronic diseases
A single HbA1c test provides valuable information for the management of chronic diseases [3].
Elevated level of HbA1c has been identified as a significant risk factor for cardiovascular diseases and stroke in
subjects who may have diabetes.
Method Comparison
Snibe BiossaysTM HbA1c assay vs. commercially
available HbA1c assay
A comparison of BiossaysTM HbA1c with a commercial HbA1c
assay test using clinical samples gave the following
correlations (%). The data from the resulting linear
regressions are summarized as:
y =1.0045x-0.0208; n=120; r=0.9975
Assay Specification
BiossaysTM HbA1c assay
Expected value 4%(NGSP)-6%(NGSP) (2.5th-97.5th percentiles)
Precision 1.70%-3.73% (4.99-11.96)
Linear Range 3.0%-15.0%
Reportable Interval 1.6%-15.0%
Limit of Blank (LoB) 1.2%
Limit of Detection (LoD) 1.6%.
Limit of Quantitation (LoQ) 3.0%
References:
[1] Use of Glycated Haemoglobin (HbA1C) in the Diagnosis of Diabetes Mellitus: Abbreviated Report of a WHO Consultation. Geneva: World Health Organization.
2011. p. 2, Glycated haemoglobin (HbA1c) for the diagnosis of diabetes. Retrieved 2 December 2018.
[2] Weykamp C. HbA1c: A Review of Analytical and Clinical Aspects. Ann Lab Med 2013; 33:393-400.
[3] Sherwani et al. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomarker Insights 2016:11 95–104.
[4] WHO. Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus.
M5036E01-20211104
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No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R. China
