HbA1c Rapid One Step Test Kit WWHS POCT CE In Blood Glucose Level Clinically

【Product Name】23. HbA1c.pdf

Haemoglobin A1c(HbA1c)Rapid Quantitative Test (Fluorescence immunoassay)

【Intended Use】

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.

【Test principle】

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.

【Components】
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.

【Applicable Instrument】

NIR-1000 dry fluorescent immunoassay analyzer produced by WWHS Biotech. Inc.

【Test procedure】

1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.
2. Start NIR-1000 dry fluorescence immunoassay analyzer according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the information card. The information card is inserted before use, so it is not necessary to calibrate again, and the test can be carried out only after the quality control is passed. Otherwise, the cause should be found out before testing.)
3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
4. Place the test card on a clean horizontal table and mark it horizontally.
5. Add 10μL of sample into HbA1c sample diluent (1.00mL). After mixing thoroughly the solution for 1 min, take 100μL of the solution and add it into the well.
6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 10 minutes after addition of samples, then dispose of used test appropriately.                                                                                                                                  

【Interpretation of Test Results】

1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose HbA1c concentration is lower than 4.0% and higher than 14.0%, test result is “＜4.0%” and “＞14.0%” respectively.

【Performance 】

1. Limits of detection

No higher than 4.0%.

2. Accuracy

The relative deviation to the target value is limited to ±10.0%.

3. Repeatability

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%.