Malaria IgG/IgM Antibody Assay Kit (Colloidal Gold)

【Product Specification】

1 Test/Kit, 20 Tests/Kit, 25 Tests/Kit, 40 Tests/Kit

【INTENDED USE】

The Malaria IgG/IgM Antibody Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf) in human serum or plasma. This device is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with Plasmodium falciparum. Any reactive specimen with the Malaria IgG/IgM Antibody Assay Test Kit (Colloidal Gold) must be confirmed with alternative testing methods such as the microscopic smear test and clinical findings.

【PRINCIPLE OF THE PROCEDURE】

The Malaria IgG/IgM Test Kit (Colloidal Gold) is a double antigen based lateral flow immunochromatographic assay. The test strip consists of: 1) a burgundy colored conjugate pad containing recombinant Pf-MSP conjugated with colloid gold (Pf conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing one test band (T band) and a control band (C band). The T band is pre- coated with recombinant Pf -MSP for the detection of antibodies to Pf only and the C band is pre- coated with goat anti rabbit IgG.

When an adequate volume of test specimen is applied to the sample pad of the strip, the specimen migrates by capillary action across the strip. Antibodies including IgG, IgM and IgA against Pf-MSP, only found in P. falciparum infection, if present in the specimen will bind to the Pf conjugates. The immunocomplex is then captured on the membrane by the pre-coated Pf-MSP, forming a burgundy colored T band, indicating a Pf positive test result.

Absence of a T band (T) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of goat anti-rabbit IgG/rabbit IgG-gold conjugate immunocomplex regardless of the color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device.

【MAIN COMPONETS】

1. Individually sealed foil pouches containing:
2. One cassette device
3. One desiccant
4. Plastic droppers
5. Sample diluent
6. One package insert (instruction for use)

【STORAGE CONDITIONS AND EXPIRY DATE】

All reagents are ready to use as supplied. Store unused test devices unopened at 2℃-30℃. The positive and negative controls should be kept at 2℃-8℃. If stored at 2℃-8℃, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30℃. The tube package must be used within 25 days from the date it is first opened. Close tube IMMEDIATELY after strip devices are removed and place tube back under original storage conditions.

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