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CTK Human Hepatitis A Virus HAV IgG/IgM Rapid Test CE
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Specimen: S, P & WB
Specifications:
| Application | Diagnostic Testing | ||
| Storage Temperature | Room Temperature | ||
| Product Type | Test Kit | Forms | Kit with Various components |
| Product Brand | CTK Biotech | ||
| Product Grade | Medical grade | ||
The OnSite® HAV IgG/IgM Rapid Test CE is a lateral flow chromatographic immunoassay designed for the qualitative detection and differentiation of IgG and IgM antibodies to Hepatitis A virus (HAV). This test enables clinicians to distinguish between acute HAV infection (IgM) and protective immunity (IgG), supporting both diagnosis and vaccination monitoring.
The assay is traceable to the 2nd WHO International Standard for HAV, with IgM performance aligned to leading ELISA tests. Its high accuracy and ease of use make it suitable for clinical laboratories, point-of-care testing, and public health programs.
Key Features
- Dual Detection: Identifies both IgG and IgM antibodies to differentiate acute infection from immunity.
- Immunity Indication: Detects HAV IgG titers ≥70 mIU/mL, confirming protective immunity.
- Performance: Sensitivity 94.8%, Specificity 96.7%.
- Specimen Flexibility: Accepts serum, plasma, or whole blood.
- Small Sample Volume: Only 5 µL required, allowing multiple tests from one sample.
- Rapid Results: Results available in 15 minutes during patient visits.
- Traceability: Calibrated against WHO International Standard for HAV.
- Convenient Storage: Stable at 2–30 °C for 24 months.
- No Special Equipment: Ideal for decentralized testing.
Kit Contents (30 Tests)
- Individually sealed foil pouches containing cassette device + desiccant
- 5 µL capillary tubes
- Sample diluent (REF SB-R0092, 5 mL/bottle)
- Package insert (Instructions for Use)
Applications
- Clinical Diagnostics: Detect and stage HAV infection (acute vs immunity).
- Vaccination Programs: Verify protective HAV immunity after immunization.
- Public Health: Surveillance in outbreak or endemic regions.
- Point-of-Care Testing: Rapid results in hospitals, clinics, and field settings.
- Research & Epidemiology: HAV seroprevalence and antibody response studies.
The OnSite® HAV IgG/IgM Rapid Test CE (R0092C) is a fast, accurate, and practical diagnostic tool for detecting and differentiating HAV IgG and IgM antibodies. With strong sensitivity and specificity, WHO standard traceability, and the ability to provide results in 15 minutes from a tiny 5 µL sample, it is an excellent choice for clinicians, vaccination programs, and public health professionals seeking reliable HAV diagnostics at the point of care.