Filariasis IgG/IgM Combo Rapid Test - India CDSCO Medical Device Registration

Product Information

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 leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below 20°C. Whole blood collected by venipuncture should be stored at 2- 8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.  Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.  If specimens are to be shipped, they should be packed in compliance with federal regulations for transportation of etiologic agents. 【MATERIALS】 Materials provided • Test cassettes • Droppers • Buffer • Package insert Materials required but not provided • Specimen collection containers • Centrifuge • Lancets (Feces) • Timer 2. The Filariasis Rapid Test is limited to the qualitative detection of antibodies to W. bancrofti and B. malayi in human serum, plasma or whole blood. The intensity of the test band does not have linear correlation with the antibody titer in the specimen. 3. A negative result for an individual subject indicates absence of detectable W. bancrofti and B. malayi antibodies. However, a negative test result does not preclude the possibility of exposure to W. bancrofti and B. malayi. 4. A negative result can occur if the quantity of W. bancrofti and B. malayi antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected. 5. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results. 6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings. 【EXPECTED VALUES】 The Filariasis IgG/IgM Rapid Test Cassette (Feces) has been compared with Culture/Histology, demonstrating an overall accuracy of 97.0%. infected larvae is required for establishment of human infection. 3 • Heparinized capillary tubes and dispensing bulb (Feces) 【PERFORMANCE CHARACTERISTICS】 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 【DIRECTIONS FOR USE】 Allow the test, specimen, buffer and/or controls to reach room temperature (Feces) IgG Results Clinical Sensitivity, Specificity and Accuracy 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 Rapid Test uses conserved recombinant antigens to simultaneously detect antibody to the W. bancrofti and B. malayi parasites without the restriction on specimen collection