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Filariasis IgG/IgM Rapid Test Uncut Sheet,WB/S/P
The Filariasis IgG/IgM 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. 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).
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.
The Filariasis IgG/IgM 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 colloid gold (Filariasis conjugates) and rabbit IgG‐gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre‐coated with monoclonal anti‐human IgM for the detection of IgM anti‐ W. bancrofti and B. malayi, T2 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 T2 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 T1 band, indicating a W. bancrofti or B. malayi IgG positive test result.Absence of any test bands (T1 and T2) 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.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2‐30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must
remain in the sealed pouch until use. Do not freeze. Do not use beyond the expiration date.
WARNINGS AND PRECAUTIONS
1.For professional in vitro diagnostic use only.
2.Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
3. This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents.
It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
4.Avoid cross‐contamination of specimens by using a new specimen collection container for each specimen obtained.
5.Read the entire procedure carefully prior to performing any tests.
6.Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
7.Do not interchange or mix reagents from different lots.
8.Humidity and temperature can adversely affect results.
Contact: Rebecca Yan
Contact Person: Ms. Anna Lee