About LEPTOSPIRA IgG/IGM COMBO RAPID TEST
The Leptospira IgG/IgM Cassette Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant L. interrogans antigens conjugated with colloidal gold (Leptospira conjugates) and rabbit IgG-gold conjugates, and A nitrocellulose membrane strip containing two test lines (M and G lines) and a control line (C line).
The M line is pre-coated with monoclonal anti-human IgM for the detection of anti-L. interrogans IgM, G line is pre-coated with reagents for the detection of anti-L. interrogans IgG, and the C line is pre-coated with goat anti rabbit IgG.
When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. IgM anti-L. interrogans, if present in the specimen, will bind to the Leptospira conjugates.
The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody forming a burgundy colored M line, indicating a L. interrogans IgM positive test result. IgG anti-L. interrogans, if present in the specimen, will bind to the Leptospira conjugates. The immunocomplex is then captured on the membrane by the pre-coated reagents forming a burgundy colored G line, indicating a L. interrogans IgG positive test result.
Absence of any test lines (M and G) suggests a negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugates regardless of color development on any of the test lines. If the C line does not develop, the test result is invalid and the specimen must be retested with another device.
Accurate and Rapid ResultsThis test provides highly accurate results, with both sensitivity and specificity exceeding 99%. The rapid detection process allows laboratory and clinical settings to obtain results within 15 to 20 minutes, facilitating timely disease management in suspected leptospirosis cases.
Convenient Sample HandlingDesigned for ease of use, the LEPTOSPIRA IgG/IGM COMBO RAPID TEST is compatible with serum, plasma, or whole blood samples. Its practical kit contents, including all required materials and clear instructions, support efficient workflows and straightforward procedures.
Reliable Quality and ComplianceManufactured in India with strict quality controls, this test is CE-marked, ensuring adherence to international standards. With a shelf life of 24 months and stable storage conditions at 2C to 30C, it offers reliability for exporters, suppliers, and end-users.
FAQs of LEPTOSPIRA IgG/IGM COMBO RAPID TEST:
Q: What is the intended use of the LEPTOSPIRA IgG/IGM COMBO RAPID TEST?
A: This rapid test is intended for the qualitative detection of Leptospira-specific IgG and IgM antibodies in human serum, plasma, or whole blood samples, aiding in the diagnosis of leptospiral infections.
Q: How is the LEPTOSPIRA rapid test performed?
A: To perform the test, add the sample (serum, plasma, or whole blood) to the test device using the provided dropper, then add buffer as instructed. Wait 1520 minutes to interpret the results within the reading window.
Q: What sample types can be used with this test kit?
A: The LEPTOSPIRA IgG/IGM COMBO RAPID TEST can be used with serum, plasma, or whole blood, offering flexibility for diverse clinical applications.
Q: When should results be read, and what is the reading window?
A: Results should be read between 15 and 20 minutes after sample application. Reading too early or too late may affect accuracy, so follow the instructions provided.
Q: Where should the test kits be stored and what is their shelf life?
A: Store the kits at temperatures between 2C and 30C to maintain integrity. Each kit has a shelf life of 24 months from the date of manufacture.
Q: What regulatory approvals does the LEPTOSPIRA rapid test have?
A: This test is CE-marked, ensuring compliance with international regulatory and safety standards for use in clinical diagnostics.
Q: What are the benefits of using this rapid test for Leptospira detection?
A: The kit delivers rapid, highly sensitive and specific results, enabling timely identification of leptospiral infections. It is easy to use, requires minimal equipment, and comes complete for immediate testing.