CTK Biotech, USA Filariasis IgG/IgM Combo Rapid 10 Test

The OnSite  Filariasis IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-lymphatic filarial parasites (W. Bancrofti and B. Malayi)in human serum, plasma or whole blood.

• Use of conserved antigens allows ‘pan-filaria’ tests to be applicable
• Simple procedure provides alternative to diagnosis by blood smear
• Use serum, plasma or whole blood
• No restrictions on time of day for sample collection
• Read clear and reliable results in 15 minutes
• Sensitivity: 100%, Specificity: 100% (vs a commercial rapid test)
• 24 month shelf life at 2-30 °C

Each kit contains:

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• Plastic droppers
• Sample diluent (1 bottle, 5 mL)
• One package insert (instruction for use)

TEST PRINCIPLE : The OnSite Filariasis IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant W. bancrofti and  B. malayi common antigens conjugated with colloidal gold (Filariasis conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing two test lines (M and G lines) and a control line (C line). The M line is pre-coated with monoclonal anti-human IgM for the detection of IgM anti- W. bancrofti and B. malayi, the G line is pre-coated with reagents for the detection of IgG anti-W. bancrofti and  B. malayi, and the C line is pre-coated with a control 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.  W. bancrofti or B. malayi IgM antibodies if present in the specimen will bind to the Filariasis conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody forming a burgundy colored M line, indicating a W. bancrofti or B. malayi IgM positive test result.   W. bancrofti or B. malayi IgG antibodies if present in the specimen will bind to the Filariasis conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane forming a burgundy colored G line, indicating a W. bancrofti or B. malayi IgG positive test result.   Absence of any test lines (M and G) 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 the color development on any of the test lines. If the C line does not develop, the test result is invalid and the specimen must be retested with another device.