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Product Introduction
High-sensitivity glycosylated hemoglobin reagent kit(HbA1c) for Automatic immunoassay analyzer in DIABETES
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Product Advantage

This kit uses double antibody sandwich method to determine the content

of HbA1c.The HbA1c in the sample binds with the alkaline

phosphatase-labeled antibody in the enzyme-labeled reagent and the

biotinylated HbA1c antibody in the antibody reagent to form a "sandwich"

structure. The streptavidin-coated magnetic beads in the excessive amount

of magnetic separation reagent forms a complex with the biotinylated

HbA1c antibody in the antibody reagent. After washing, the luminescent

substrate is catalyzed by the enzyme in the complex to form an unstable

excited state intermediate. When the excited state intermediate returns to

the ground state, the photons are emitted. The number of photons

produced is positively related to the concentration of HbA1c in the


Technical Parameters

Product Uses

(1) Glycated hemoglobin level can be used as a diagnostic test for diabetes. Glycated hemoglobin ≥ 6.5% can be used as the basis for the diagnosis of diabetes. However, a result below 6.5% does not rule out the possibility of diabetes, and the results of the glucose measurement should also be consulted. If the glycated hemoglobin is >9.0%, it means that the patient has persistent hyperglycemia.

2) Glycated hemoglobin level can be used as a test to assess the risk of complications. Studies have shown that the average HbA1c decreases by 1%. The risk of death associated with diabetes was reduced by 21%, myocardial infarction by 14%, and microvascular complications by 37%.  For every 10% reduction in HbA1c levels, the risk of retinopathy is reduced by 43%-45%

(3) Glycated hemoglobin level as a detection method for screening high-risk groups of diabetes. Because of the continuum of risk associated with elevated HbA1 levels, those with HbA1c levels below the diabetes threshold but ≥6.0% should receive effective preventive interventions. But patients with HbA1c levels below 6.0% may also be at risk.

(4) The level of glycosylated hemoglobin has certain significance in judging different stages of diabetes.

(5) The glycated hemoglobin level is the gold standard for measuring blood sugar control, and it has a positive effect on adjusting the treatment plan and discovering the problems existing in the treatment.

(6) It can be used for differential diagnosis with other diseases. For example, under stress conditions such as cerebrovascular emergency, blood sugar increases but glycosylated hemoglobin does not increase.

(7) In the management of gestational diabetes mellitus, it is not enough to control blood sugar alone, but also control the level of glycosylated hemoglobin, which has a positive effect on the prevention of eclampsia, macrosomia, teratogenesis, and stillbirth.

Product Operate Guide

[Applicable instruments]

POClia CLIA analyzer manufactured byTaizhou Zecen Biotech Co.,

Ltd., models:POClia 8, POClia minus, POClia plus, POClia auto.

[Sample requirements]

The sample type used is whole blood, other sample types may not get

accurate results, it is recommended to use whole blood for

testing.Collect samples using standard procedures.

Sample volume cannot be less than 200μL.

Store at 2-8℃: 24 hours, for longer storage periods: freeze to below -


Avoid repeated freezing and thawing cycles, stored samples should be

thoroughly mixed prior to use (Vortex mixer).

Please ask local representative of ZECEN for more details if you have any


[Testing Method]

Note: Please read the instruction manual carefully before use. Working

conditions: room temperature (15~30°C); Relative humidity≤ 80%.

[Preparation before the test]

Before the test, all reagents should be put to room temperature, and

the instrument should be turned on for at least 30 minutes;


1: What is the detection principle?

Magnetic particle chemiluminescence method

2: Is it tested on a closed instrument?

Yes, only applicable to analyzers produced by Zecheng?

3: What is the minimum order quantity?

We have stock"

Zecen Biotech CO., LTD. founded in 2011, is a leading Chinese diagnostics manufacturer specializing in in-vitro diagnostics devices and reagents.
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Phone: +86-523-86817711
Add: Building G62, Phase 4 Plant, China Medical City, Taizhou City, Jiangsu Province
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