CTK Biotech, USA HAV IgM Rapid 10 Test

The OnSite HAV IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of IgM antibodies to hepatitis A virus (HAV) in human serum, plasma or whole blood.

• Instant screening test
• Detects IgM anti-HAV in serum, plasma and whole blood
• Evaluated with BBI seroconversion panel (PHT903)
• Useful for identifying acute HAV infections
• Comparable performance v.s. EIA: relative sensitivity: 90.6%, relative specificity: 97.6%, overall agreement:  95.4%
• 24 month shelf life at 2-30°C

Each kit contains :

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• Capillary Tubes (5 µL)
• Sample Diluent (1 vial, 5 mL)
• One package insert (instruction for use)

TEST PRINCIPLE  : The OnSite HAV IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing HAV antigen conjugated with colloidal gold (HAV Ag conjugates) and a control antibody conjugated with colloidal gold and 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with mouse anti-human IgM, and the C line is pre-coated with a control line antibody. When an adequate volume of test specimen and sample diluent are dispensed into the sample and buffer wells of the cassette, respectively, the specimen migrates by capillary action across the cassette. IgM anti-HAV, if present in the specimen, will bind to the HAV Ag conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-human IgM forming a burgundy colored T line, indicating an IgM anti-HAV positive test result. Absence of the T line suggests an IgM anti-HAV negative test result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the immunocomplex of control line antibodies regardless of any color development on the T line. If the C line does not develop, the test result is invalid, and the specimen must be retested with another device.