Chagas Ab Rapid Test
Short Description
This Chagas Ab Rapid Test Cassette is a high-precision chromatographic immunoassay engineered for the professional qualitative detection of antibodies to Trypanosoma cruzi. Designed as a critical diagnostic aid for Chagas disease, this versatile test is compatible with human whole blood, serum, and plasma specimens. By delivering rapid and reliable results, it facilitates early clinical screening and supports effective infection management in professional in vitro diagnostic (IVD) environments.
Characteristics
The test boast of rapid and accurate diagnosis with the following characteristics:
Accuracy:A comparison test was conducted using The Genfocus® Chagas Ab Rapid Test and commercially available Chagas Ab rapid tests. 109 clinical specimens were evaluated. The following results are tabulated from these clinical studies:
Clinical sensitivity is 97.30%,
Clinical specificity is 98.61%,
Accuracy is 98.17%.
Specifications
Item | Value |
| Product name | Chagas Ab Rapid Test |
| Place of Origin | Beijing, China |
| 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 | Whole Blood, Serum, Plasma specimens. |
| Sample | Available |
| Format | Cassete |
| Certificate | CE Approved |
| OEM | Available |
| Package | 1pc/box, 25pcs/box, 50 pcs/box, 100pcs/box, customized |
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 Chagas Ab Rapid Test used for?
This test is a chromatographic immunoassay designed for the qualitative detection of antibodies to Trypanosoma cruzi in whole blood, serum, or plasma to aid in the diagnosis of Chagas disease.
2. What is the accuracy of this Chagas antibody diagnostic kit?
Clinical studies show the test has a sensitivity of 97.30%, a specificity of 98.61%, and an overall diagnostic accuracy of 98.17%.
3. Which specimen types are compatible with the Chagas test?
The test cassette is versatile and can be used with human whole blood, serum, or plasma specimens for professional diagnostic use.
4. How long is the shelf life of the Chagas Ab Rapid Test?
The product has a stable shelf life of 2 years when stored under appropriate conditions, ensuring long-term reliability for clinical supply.
5. Is this Chagas diagnostic kit certified for quality?
Yes, the manufacturing and product quality are certified under ISO 9001 and ISO 13485 international standards, and it is CE approved.
6. What is the format of this Chagas diagnostic tool?
The test is provided in an easy-to-use cassette format, which is ideal for rapid screening and point-of-care (POC) applications.
7. How is the Chagas test kit packaged for professional use?
Standard packaging includes options for 1pc/box, 25pcs/box, 50pcs/box, or 100pcs/box, with each unit sealed in an individual aluminum foil bag.
8. Is any specialized power source or equipment required for the test?
No, this is a manual rapid test that does not require an external power source or complex laboratory instrumentation for result interpretation.
9. Does the manufacturer offer OEM services for Chagas test kits?
Yes, OEM packaging and customized branding services are available to meet specific market or institutional requirements.
10. What is the instrument classification for this diagnostic product?
This Chagas antibody test is classified as a Class II medical instrument, suitable for professional in vitro diagnostic (IVD) use.
11. How does the rapid test assist in managing Chagas disease?
By providing rapid and accurate detection of T. cruzi antibodies, it allows for early screening and timely medical intervention for infected individuals.
12. What is the origin and manufacturing quality of the kit?
The kit is manufactured in Beijing, China, under strict quality control protocols to ensure consistent performance across all batches.
13. Is after-sales support provided for the Chagas rapid test?
Yes, online technical support is available to assist healthcare professionals with testing procedures and result interpretation.
14. What are the storage requirements for the test cassette?
The kit should be stored in its original packaging at room temperature or as specified to maintain the integrity of the immunoassay.
15. Can this test be used for blood donor screening?
While intended as a diagnostic aid, its high sensitivity makes it a valuable tool for initial screening of Trypanosoma cruzi antibodies in various clinical settings.
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