INTENDED USE

The Filariasis IgG/IgM Rapid Test Kit 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. 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 Combo Rapid Test must be confirmed with alternative testing method(s).

SUMMARY AND EXPLANATION THE TEST

The lymphatic filariasis known as Elephantiasis, mainly caused by W. bancrofti and B. malayi, affects about 120 million people over 80 countries. The disease is transmitted to humans by the bites of infected mosquitoes within which the microflariae sucked from an infected human subject develops into third-stage larvae. Generally, repeated and prolonged exposure to infected larvae is required for establishment of human infection.
The definitive parasitologic diagnosis is the demonstration of microflariae in blood samples. However, this gold standard test is restricted by the requirement for nocturnal blood collection and lack of adequate sensitivity. Detection of circulating antigens is commercially available. Its usefulness is limited for W. bancrofti. In addition, microfilaremia and antigenemia develop from months to years after exposure.
Antibody detection provides an early means to detect filarial parasite infection. Presence of IgM to the parasite antigens suggest current infection, whereas, IgG corresponds to late stage of infection or past infection. Furthermore, identification of conserved antigens allows ‘pan-filaria’ test to be applicable. Utilization of recombinant proteins eliminates cross-reaction with individuals having other parasitic diseases. The Filariasis IgG/IgM Combo Rapid Test uses conserved recombinant antigens to simultaneously detect IgG and IgM to the W. bancrofti and B. malayi parasites without the restriction on specimen collection.

PRINCIPLE

The Filariasis IgG/IgM Rapid Test Kit 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 colloid gold (Filariasis conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (M and G bands) and a control band (C band). The M band is pre-coated with monoclonal anti-human IgM for the detection of IgM anti- W. bancrofti and B. malayi, G band is pre-coated with reagents for the detection of IgG anti-W. bancrofti and B. malayi, and the C band is pre-coated with goat anti rabbit IgG.
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 band, 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 band, indicating a W. bancrofti or B. malayi IgG positive test result.
Absence of any test bands (M and G) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.