Product Description
| Brand | CTK Biotech |
| Sample Type | Serum/ Plasma/ WB |
| Pack Size | 10T |
| CAT No | R0092C |
The OnSite HAV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to Hepatitis A virus (HAV) in human serum, plasma or whole blood.
Advanced Technology for Reliable DetectionUtilizing lateral flow immunoassay technology with high-quality nitrocellulose membrane and specialized reagents, the test delivers dependable, visual results for HAV exposure in under 15 minutes. Its precision ensures clinical confidence in identifying both IgG and IgM antibodies.
User-Friendly Design and PackagingEach test is packaged individually in a sealed, lightweight pouch with desiccant and clear usage instructions. The test cassette features a color indicator for easy readout, requiring only a single-use procedure without the need for complex instruments. Its compact format makes it suitable for on-site and point-of-care applications.
Professional Quality with CE Mark CertificationCE marking verifies that this rapid test kit meets rigorous European standards for in vitro diagnostics. Its high accuracy, single-use safety, and user-compliant packaging make it an ideal choice for healthcare professionals, laboratories, and clinics across India.
FAQ's of CTK Biotech OnSite HAV IgG/IgM Rapid Test CE:
Q: How does the CTK Biotech OnSite HAV IgG/IgM Rapid Test work?
A: This rapid test uses a lateral flow immunoassay to detect HAV-specific IgG and IgM antibodies in human serum, plasma, or whole blood. The sample is applied to the cassette, and colored lines appear within 10-15 minutes, indicating a qualitative positive or negative result.
Q: What types of samples can be used with this test kit?
A: The kit is compatible with serum, plasma, or whole blood, providing flexibility depending on the available specimen and clinical setting.
Q: What are the storage requirements for this rapid test kit?
A: Store the test kit at temperatures between 2-30C. It is important to avoid freezing, as this can compromise the test's accuracy and shelf life, which is 24 months from the date of manufacture.
Q: Who is authorized to use the CTK Biotech OnSite HAV IgG/IgM Rapid Test CE?
A: This test is designed for professional in vitro diagnostic use only. It should be used by trained healthcare personnel or laboratory professionals in a clinical or laboratory environment.
Q: How accurate are the test results?
A: The test delivers results with more than 99% sensitivity and specificity for detecting HAV antibodies, ensuring high-confidence in both negative and positive outcomes.
Q: Can the test be used multiple times or reused?
A: No, each rapid test kit is intended for single use only. Reusing the cassette compromises result integrity and is not recommended.
Q: What is the main benefit of using this rapid test kit?
A: The primary advantage is its rapid, accurate, and easy-to-interpret results, enabling timely clinical decisions and effective screening for HAV. Its portable and individually packaged design further enhances convenience for point-of-care use.