【Product Name】
Haemoglobin A1c(HbA1c)Rapid Quantitative Test (Fluorescence immunoassay)
【Packing Specification】
25 Tests/kit
【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%.
【Components】
| Name | Quantity | Component |
| 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.
【Test procedure】
- 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.
- 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.)
- Remove the test card from the aluminum foil bag and use it within 15 minutes.
- Place the test card on a clean horizontal table and mark it horizontally.
- 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.
- 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.
【Note】
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.
FAQ:
Q. How is your company's product after-sales service system?
A. The product warranty period is 12 months, we can provide lifetime maintenance. We have professional pre-sales and after-sales teams that can respond to you within 24 hours to resolve technical issues. We provide one-to-one after-sales service.
Q: Can you customize it?
A: Yes, we accept customization according to customer's specific requirements.
Q. How long is your lead time? If I want to customize instruments, how long will it take?
A. When order quantity is 1-10 units, we have ready stock goods, we can ship out within 3-5 working days after receipt of deposit; products required new production of common materials, usually the lead time is about 10-15 days; products requiring new production of special and rare materials, usually the lead time is about 20-30 days.
Most Of FIA Rapid Test Cassette Assay Such As Cardiac and Inflammation Items Are Available For 5-10 days Prompt Shipment.
Q. What payment method do you accept?
A. Our company accept payment method of T/T (bank transfer), Western Union, PayPal and so on.
Q. What package do you use for your products? What shipping method do you use?
A.1. Our company use standard exporting carton for packing. 2. We ship via express courier (door to door service), by air, and by sea according to customers' requirements.
For more questions, please feel free to send inquiries to us.
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Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package Images
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