CTK Biotech, USA CMV IgG/IgM Rapid 30 Test

The OnSite CMV IgG-IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgM and IgG antibodies to Cytomegalovirus (CMV) in human serum or plasma.

This product features:

A lateral flow immunoassay for the simultaneous detection and differentiation of IgM and IgG antibodies to Cytomegalovirus (CMV) in human serum or plasma.

Each kit contains:

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• Plastic droppers
• Sample Diluent (1 vial, 5 mL/bottle)
• One package insert (instruction for use)
• The test result should be read 10 minutes after a specimen is applied to the sample well or sample pad of the device. Any results interpreted outside 10-15 minutes should be considered invalid and must be repeated. 13

Clinical Performance For IgM Test Relative Sensitivity:  97.6%,  Relative Specificity:  98.5%, Overall Agreement:  98.3% Clinical Performance For IgG Test Relative Sensitivity:  98.2%,  Relative Specificity:  99.1%, Overall Agreement:   98.8% TEST PRINCIPLE : The CMV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing CMV antigens conjugated with colloidal gold (CMV 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 anti-human IgG for detection of anti-CMV IgG. The M line is precoated with mouse anti-human IgM for detection of anti-CMV 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-CMV IgG is present in the specimen, it will bind to the CMV conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-human IgG forming a burgundy colored G line, indicating a CMV IgG positive test result. If anti-CMV IgM is present in the specimen it will bind to the CMV conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse antihuman IgM forming a burgundy colored M line, indicating a CMV IgM positive result. Absence of any test lines (G or M) suggests a negative test 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.