INTENDED USE
The Filariasis IgG/IgM Test Kit (Colloidal Gold) is a lateral flow immuno assay 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. This test is intended to be used as a screening test and as an aid in the diagnosis of infection with lymphatic filarial parasites. Any reactive specimen with the Filariasis IgG/IgM Test Kit (Colloidal Gold) must be confirmed with alternative testing methods. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods.
The Filariasis IgG/IgM Test Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay.
The test card contains:
1. Colloidal gold-labeled antigen and quality control antibody complex.
2. Nitrocellulose membranes immobilized with two test lines (M line and G line) and one quality control line (C line).
When an appropriate amount of sample is added to the sample well of the test card, the sample will move forward along the test card under capillary action.
W. bancrofti or B. malayi IgM antibodies if present in the specimen willbind 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 conjugate regardless of the color development on any of the test lines.Otherwise, the test result is invalid and the specimen must be retested with another device.
Interpretation Of The Result
NEGATIVE: If only the quality control line C appears, and the test lines M and G are not purple/red, it indicates that no antibody is detected, and the result is negative.
POSITIVE: IgM positive: If both the quality control line C and the test line M appear purple/red, it indicates that the Ig M antibody is detected, and the result is positive for Ig M antibody.
IgG positive: If both the quality control line C and the test line G appear purple/red, it indicates that the Ig G antibody is detected, and the result is positive for Ig G antibody.
IgM and IgG positive: If the quality control line C and the test lines M and G all appear purple/red, it indicates that the Ig M and Ig G antibodies are detected, and the result is positive for both IgM and IgG antibodies.
INVALID: If the quality control line C is not displayed, the test result is invalid regardless of whether there is a purple/red test line, and it should be tested again.
