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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.
|Test cards||25||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.|
|Sample diluent||25 (1.0mL/ tube)||Phosphate buffer|
|ID card||1||With specific stand curve file|
The components in different batches of kits cannot be used interchangeably.
【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.
Test and analyze the HbA1c in the whole blood from 269 healthy people aged 17-89, according to 95th percentile method, the result shows that HbA1c reference interval is 4.0%-6.0%. It is strongly recommended that each laboratory should determine its own normal and abnormal values.
【Interpretation of Test Results】
【Limitation of Test Method】
1. The kit is only used to test whole blood specimens of human body.
2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
3. The content of triglyceride in the sample shall not exceed 10mg/ml, the content of bilirubin shall not exceed 0.2mg/ml, the content of glucose shall not exceed 10mg/ml, and the relative deviation is limited to ±10.0%.
4. When HbA1c concentration of samples reaches 18.0%, there is no hook effect.
6. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±10.0%.
7. For samples exceeding the linearity range, test cannot be conducted after dilution.
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%.
1. The kit can be used for in vitro diagnosis only.
2. Test card and buffer solution are single-use and they cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.
5. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.
6. The kit used should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.
1) The test card can be used only once at room temperature, do not reuse or use test card out of expiry date.
2) Return all reagents and sample into room temperature before use.
3) Be careful when prepare sample, wear glove and mask.
4) The whole blood need add anticoagulants, not frozen; serum sample can store in frozen, avoid repeated freezing and thawing.
5) This product is only for in vitro rapid diagnostic human use, can be quantified, not only qualitative testing.
6) The product test results for reference only, for confirmation, please refer to the relevant national standard methods.
1. What is the MOQ?
Generally if you choose the different products, our minimum order qty. also will be different. One sample available.
2. What about the delivery time?
The goods need 7-21 work days to be made upon deposit.
3. Does your product have any warranty?
Yes, we offer 6 months limited warranty for our products.
Damage due to misuse, ill treatment and unauthorized modifications and repairs are not covered by our warranty.
4. What's your shipping method?
We provide comprehensive shipping methods.
For small quantity orders we ship by DHL Air-Express, or EMS/TNT/UPS/FEDEX Express service, it is safe and fast.
For large quantity orders we ship by Air transportation or sea transportation, we can also ship order to buyer’s cargo agent in China.
Send your inquiry directly to us