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

Categories IVD Products
Brand Name: Zecen
Model Number: CLIA HbA1c
Certification: CE, ISO13485
Place of Origin: China
MOQ: 10 boxes
Payment Terms: L/C, D/A, D/P, T/T, Western Union, MoneyGram
Supply Ability: 5000 Set/Sets per Month
Delivery Time: 15 working days
Packaging Details: Carton package
Name: HbA1c
Analyzer: CIA series
Principle: CLIA
Recalibration: 2 or 6-points
Storage: 2-8°C
Material: Magnetic beads, calibrators, Anti A/B, control1/2
Validity period: 18 months
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High-sensitivity glycosylated hemoglobin reagent kit(HbA1c) for Automatic immunoassay analyzer in DIABETES

CLIA Reagents of DIABETES (HbA1c)


Test itemHbA1c
Specification100 Test/Box for CIA series
24 Test/Box for POCT
Principle
  • Competition method

ComponentMagnetic Beads
Calibrator Low
Calibrator High
HbA1c Anti
Control 1
Control 2
Accessories Required But Not ProvidedSubstrate
Washing solution
Sample materialserum
Sample volumeMore than 200μL
Storage2-8℃

Glycated hemoglobin (HbA1c) is the product of the combination of hemoglobin in red blood cells and sugars (mainly glucose) in serum through a non-enzymatic reaction. The non-enzymatic reaction to form glycated hemoglobin is continuous, slow and irreversible, so the content of glycated hemoglobin is determined by the past rather than immediate blood glucose concentration, and whether it is fasting before the test, whether to inject insulin, whether to take hypoglycemic drugs, etc. Factors are irrelevant. It is generally believed that the concentration of glycated hemoglobin can effectively reflect the average blood glucose level of the past 8 to 12 weeks. Glycated hemoglobin is composed of HbA1a, HbA1b, and HbA1c, of which HbA1c accounts for about 70%, and the structure is relatively stable.


(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.




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