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Filariasis IgG/IgM Rapid Test Device


Short Description:

The Filariasis IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) 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 Rapid Test must be confirmed with alternative testing method(s).



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SUMMARY AND EXPLANATION OF THE TEST

The lymphatic filariasis known as Elephantiasis, mainly caused by W. bancrofti and B. malayi, affects about 120 million people over 80 countries1,2. 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 samples3.

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. bancrofti4. 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 infection5. Furthermore, identification of conserved antigens allows 'pan- filaria' test to be applicable. Utilization of recombinant proteins eliminates cross-reaction with individuals having other parasitic diseases6. The Filariasis IgG/IgM 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.

Procedure

ASSAY PROCEDURE:

1. Bring the specimen and test components to room temperature if refrigerated or frozen. Place the test device on a clean, flat surface.

2. For whole blood test
Apply 1 drop of whole blood (about 40-50 µL) into the sample well. Then add 1 drop (about 35-50 µL) of Sample Diluent immediately.

For serum or plasma test
Fill the pipette dropper with the specimen. Holding the dropper vertically, dispense 1 drop (about 30-45 µL) of specimen into the sample well making sure that there are no air bubbles. Then add 1 drop (about 35-50 µL) of Sample Diluent immediately.

3. Set up timer. Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute. Don’t read result after 15 minutes.

Interpretation Of Assay Result

1.In addition to the presence of C band, if only T1 band is developed, the test indicates for the presence of anti-W. bancrofti or B. malayi IgG antibody. The result is positive.

2.In addition to the presence of C band, if only T2 band is developed, the test indicates for the presence of anti-W. bancrofti or B. malayi IgM antibody. The result is positive.

3.In addition to the presence of C band, both T1 and T2 bands are developed, the test indicates for the presence of both IgG and IgM anti-W. bancrofti or B. malayi. The result is also positive.

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If only the C band is present, the absence of any burgundy color in the both test bands (T1 and T2) indicates that no anti-W. bancrofti or -B. malayi antibody is detected in the specimen. The result is negative.

If only the C band is present, the absence of any burgundy color in the both test bands (T1 and T2) indicates that no anti-W. bancrofti or -B. malayi antibody is detected in the specimen. The result is negative.

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