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.