HEV IgM Rapid Test
CTK Biotech, USA HEV IgM Rapid 10 Test
A lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies to hepatitis E virus (HEV) in human serum or plasma.
- Instant screening test
- Detects IgM anti-HEV in serum or plasma
- Evaluated with BBI HEV serum conversion and HEV mixed titer performance panels
- Useful for identifying acute HEV infections
- Comparable performance v.s. EIA: relative sensitivity: 98.1%, relative specificity: 99.2%, overall agreement: 98.1%
- 24 month shelf life at 2-30°C
Each kit contains :
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- 10 µL Capillary tubes
- Sample Diluent (5mL/bottle)
- One package insert (instruction for use)
TEST PRINCIPLE :
The OnSite HEV IgM Rapid Test is a lateral flow chromatographic immunoassay. The test strip in the cassette device consists of: 1) a burgundy colored conjugate pad containing HEV antigens conjugated with colloidal gold (HEV conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with monoclonal antihuman IgM antibody, and the C line is pre-coated with a control line antibody.
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. Anti-HEV IgM if present in the specimen will bind to the HEV conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM forming a burgundy colored T line, indicating a HEV IgM positive test result and suggesting an acute infection.
Absence of the test line suggests a negative result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of the control line antibodies regardless of color development on the T line. Otherwise, the test result is invalid and the specimen must be retested with another device.
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