Enterovirus 71 IgM Antibody Test Kit
This in vitro diagnostic (IVD) kit is specifically engineered for the qualitative detection of Enterovirus 71 (EV71) IgM antibodies. Compatible with human serum, plasma, and whole blood, it serves as a critical tool for the early clinical identification of Hand, Foot, and Mouth Disease (HFMD) by detecting acute-phase immune responses.
Specifications
The test boast of rapid and accurate diagnosis with the following characteristics:
The positive coincidence rate (+/+) = 12/12 of the internal control reference product of this product, the negative coincidence rate (-/-) = 12/12, the precision (n=10) results are all positive, the color rendering is uniform, and the
test result of the lowest detection out-limit L1 after dilution by 1:8 and 1:16 must be positive, and the test result of L2 must be negative.
Specifications
Item | Value |
| Product name | Enterovirus 71 IgM Antibody Test Kit |
| Power Source | Manual |
| Warranty | 2 years |
| After-sale Service | Online technical support |
| Material | Plastic, paper |
| Shelf Life | 2 years |
| Quality Certification | ISO9001, ISO13485 |
| Instrument classification | Class II |
| Specimen | human serum, plasma or whole blood samples |
| Sample | Available |
| Format | Cassete |
| Certificate | CE Approved |
| OEM | Available |
| Package | 1 test/bag. Strip type :25 tests/ Kit,40 tests/Kit, 50 tests/Kit, 100 tests/Kit. Card type :25 tests/ Kit,40 tests/Kit, 50 tests/Kit, 100 tests/Kit. |
Packaging & delivery
Packaging: 1pc/box; 25pcs/box, 50 pcs/box, 100pcs/box, individual aluminium foil bag package for each piece product; OEM packing is available.
Port: any ports of China, optional.
FAQs:
1. What is the Enterovirus 71 (EV71) IgM Test Kit used for?
It is used for the qualitative in vitro detection of IgM antibodies to Enterovirus 71, aiding in the early diagnosis of Hand, Foot, and Mouth Disease (HFMD).
2. What are the compatible specimen types for this EV71 kit?
The test is validated for use with human serum, plasma, and whole blood samples.
3. What does a positive IgM result indicate for EV71?
An IgM-positive result typically indicates a recent or acute infection with Enterovirus 71, which is crucial for early intervention.
4. Does this kit require any laboratory equipment?
No, this is a manual rapid test kit (RDT) that requires no power source or specialized machinery for operation.
5. What is the internal control coincidence rate of this product?
The kit boasts a 100% positive (+/+) and negative (-/-) coincidence rate (12/12) against internal control reference products.
6. How is the precision of the EV71 test measured?
In precision testing (n=10), all results showed uniform color rendering and consistent positive detection, ensuring high reliability.
7. What is the detection limit (sensitivity) of the assay?
The test remains positive at a 1:16 dilution of the L1 reference limit, demonstrating high sensitivity for low antibody titers.
8. Is this EV71 test kit CE approved?
Yes, the product is CE approved and manufactured in compliance with ISO9001 and ISO13485 quality standards.
9.What formats are available for the EV71 test?
The kit is available in both cassette (card) and strip formats to suit different clinical or laboratory preferences.
10. What is the shelf life and warranty?
The test kit has a shelf life of 2 years (24 months) and comes with a 2-year warranty and online technical support.
11. Are OEM services available for international distributors?
Yes, OEM packaging and private labeling are available for various kit sizes (25 to 100 tests/kit).
12. What is the packaging specification for individual tests?
Each test is individually packaged in a sealed aluminum foil bag to ensure stability and prevent contamination.
13. Can this test differentiate EV71 from other enteroviruses?
This specific kit targets EV71 IgM antibodies, which are the primary markers for severe cases of HFMD compared to other strains like Coxsackievirus.
14. What is the recommended storage condition?
The kit should be stored according to the temperature range specified on the package, typically in a dry place away from direct sunlight.
15. How are the results of the EV71 IgM test interpreted?
A visible colored band in the test region (T) along with a control band (C) indicates a positive result for EV71 IgM antibodies.
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