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【Product Name】23. HbA1c.pdf
Haemoglobin A1c(HbA1c)Rapid Quantitative Test (Fluorescence immunoassay)
The kit is used for quantitative determination of HbA1c in human whole blood,and is mainly used for diagnosis of diabetes and monitoring of blood glucose level clinically.
This kit is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of HbA1c. The HbA1c antigen in the sample was first bound with the conjugated compound of fluorescent labeled HbA1c monoclonal antibody, then moved and combined with Hb monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluorescence immunoassay.
The components in different batches of kits cannot be used interchangeably.The product consists of fluorescent mat (coated with fluorescently-labeled HbA1c mouse antibody), nitrocellulose membrane (coated with HbA1c mouse antibody and Goat anti mouse IgG antibody), absorbent paper and PVC soleplate, and so on.
【Storage Conditions and Validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.
NIR-1000 dry fluorescent immunoassay analyzer produced by WWHS Biotech. Inc.
【Interpretation of Test Results】
1. Limits of detection
No higher than 4.0%.
The relative deviation to the target value is limited to ±10.0%.
Coefficient of variations are within 10%.
4. Batch-to-batch difference
The relative range (R) between batches shall not be greater than 15.0%.
5. Linearity range
Within the specified linearity range (4.0%-14.0%):
a) Linearly dependent coefficient (r) is no less than 0.9900;
b) Within (4.0%-6.0%), linear absolute deviation is limited to ±0.6%.
Within (6.0%-14.0%), linear absolute deviation is limited to ±10.0%.
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