One Step FIA HBA1C Rapid Test Kit 500 Tests/Hour CE Approval

【Product Name】

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

【Packing Specification】

25 Tests/kit

【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.

【Components】

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.

【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.

【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.

5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.

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.

【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%.

FAQ:

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 payment method?

We usually accept the payment methods include PayPal, TT, and Western Union.

50% deposit in advance and balance before shipping. Buyer can choose which payment ways that you accept.

PayPal is most useful and safe, please don’t refuse PayPal fee when you choose PayPal.

5. 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.