CTK Biotech, USA HAV IgG/IgM Rapid 10 Test

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.

• Single test for identifying acute infection and protective immunity by detecting and differentiating IgG and IgM anti-HAV.

• Indicates protective immunity by detecting HAV IgG titers ?70 mIU/mL.
• High confidence as it is traceable to the 2nd WHO International Standard for HAV, and IgM is in agreement with market leading ELISA test: Sensitivity: 94.8%; Specificity: 96.7%.
• Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
• Small sample volume (5 µL) enables multiple testing on the same specimen without having to re-draw the patient.
• Initial patient care action can begin during the patient’s visit as test results are available in 15 minutes.
• Easily transported, and can be stored for 24 months, 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 IgG/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 HAV antigens conjugated with colloidal gold (HAV conjugates) and a control antibody conjugated with colloidal gold; 2) a nitrocellulose membrane strip containing two test lines (G and M lines) and a control line (C line). The G line is pre-coated with mouse antihuman IgG for detection of anti-HAV IgG.  The M line is pre-coated with mouse anti-human IgM for detection of anti-HAV IgM. The C line is pre-coated with a control antibody.    When an adequate volume of test specimen and sample diluent is dispensed into the sample well and buffer well, respectively, the specimen migrates by capillary action across the test strip.  If anti-HAV IgG is present in the specimen, it will bind to the HAV conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-human IgG forming a burgundy colored G line, indicating an HAV IgG positive test result. If anti-HAV IgM is present in the specimen it will bind to the HAV conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse antihuman IgM forming a burgundy colored M line, indicating an HAV IgM positive test result.   Absence of any test lines (G or M) 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 antibodies, regardless of color development on the test lines (G and M). If no control line (C line) develops, the test result is invalid and the specimen must be retested with another device.