Tuberculosis Antibody Test Kit
The Mycobacterium tuberculosis (TB) Antibody Detection Kit is engineered for the qualitative screening of TB antibodies in human serum, plasma, or whole blood specimens. This rapid immunoassay facilitates the auxiliary diagnosis of tuberculosis infections without the need for specialized laboratory instrumentation, providing an efficient tool for preliminary clinical assessment by professional healthcare providers.
Characteristics
The test boast of rapid and accurate diagnosis with the following characteristics:
1150 clinical samples were tested simultaneously with this reagent and Aikang reagent, the positive
coincidence rate was 98.84%, the negative coincidence rate was 98.91%, and the total coincidence rate was 98.87%. 2. The common interfering substance whose concentration is less than or equal to the following values doesn’t influence on the test results of this product.
Specifications
Item | Value |
| Product name | Tuberculosis Antibody Test Kit |
| Place of Origin | Beijing, China |
| Brand Name | JWF |
| Model Number | ********** |
| 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 |
| Safety standard | None |
| Specimen | blood specimen |
| Sample | Available |
| Format | Cassete |
| Certificate | CE Approved |
| OEM | Available |
| Package | 1 test/Kit，25 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 primary use of the Tuberculosis (TB) Antibody Test Kit?
It is designed for the preliminary clinical screening and qualitative detection of Mycobacterium tuberculosis antibodies in human blood samples.
2. How accurate is this TB antibody rapid test?
In clinical trials of 1,150 samples, the kit demonstrated a 98.84% positive coincidence rate and a 98.87% total coincidence rate.
3. What specimen types are compatible with the TB test?
The test is compatible with human serum, plasma, and whole blood specimens for professional diagnostic use.
4. Does this TB test kit require any laboratory equipment?
No, this reagent is designed for manual operation and requires no specialized instrumentation, making it ideal for rapid screening.
5. Is this product CE and ISO certified
?Yes, the Tuberculosis Antibody Test Kit holds CE approval and is manufactured under ISO9001 and ISO13485 quality standards.
6. What is the shelf life of the TB antibody cassette?
The product has a stable shelf life of 2 years (24 months) when stored according to the manufacturer's instructions.
7. How is the test result visually interpreted?
The presence of a color band in the detection area indicates a positive result for Mycobacterium tuberculosis antibodies.
8. Can common interfering substances affect the test results?
No, the test is engineered to resist common interfering substances at or below standard clinical concentrations.
9. What are the available packaging configurations?
We offer various formats, including 1 test/kit for individual use and 25 tests/kit for professional clinical settings.
10. Is OEM service available for the TB test kit?
Yes, OEM services including custom packaging and private labeling are available for international distributors.
11. What is the instrument classification for this diagnostic kit?
This TB antibody detection kit is categorized as a Class II medical instrument for professional in vitro diagnostic use.
12. What is the benefit of the "double-antibody" or "specific-antigen" method?
It ensures high sensitivity and specificity in capturing the target antibodies, reducing the risk of false positives or negatives.
13. How fast can I get the results?
The test provides qualitative results quickly, typically within minutes of sample application (refer to the manual for exact timing).
14. Where can this kit be used?
It is suitable for auxiliary diagnosis in hospitals, clinics, and professional laboratories for tuberculosis screening.
15. What is the storage temperature for the kit?
The kit should be stored in its sealed foil pouch under regulated conditions to maintain the 2-year warranty period.
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