Malaria Pf/Pan Antigen Assay Kit (Colloidal Gold)

【Product Specification】

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

【INTENDED USE】

The Malaria Pf/Pan Antigen Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax, P.  ovale, or P. malariae antigen in human blood specimen. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with plasmodium. Any reactive specimen with the Malaria Pf/Pan Antigen Assay Kit (Colloidal Gold) must be confirmed with alternative testing method(s) and clinical findings.

【PRINCIPLE OF THE PROCEDURE】

The Malaria Pf/Pan Antigen Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay. The test strip components consist of: 1) a burgundy colored conjugate pad containing mouse anti-pHRP-II antibody conjugated with colloidal gold (pHRP II-gold conjugates), mouse anti-pLDH antibody conjugated with colloidal gold (pLDH-gold conjugates) and chicken IgY conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing two test bands (Pan and Pf bands) and a control band (C band). The Pan band is pre-coated with monoclonal anti-pLDH antibody by which the infection with any of the four species of plasmodia can be detected, the Pf band is pre-coated with polyclonal anti-pHRP-II antibodies for the detection of Pf infection, and the C band is coated with goat anti-chicken IgY.

During the assay, an adequate volume of the blood specimen is dispensed into the sample well (S) of the test cassette, and a lysis buffer is added to the buffer well (B). The buffer contains a detergent that lyses the red blood cells and releases various plasmodium antigens which migrate by capillary action across the strip held in the cassette. pHRP-II if present in the specimen will bind to the pHRP II-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-pHRP-II antibodies forming a burgundy colored Pf band, indicating a Pf positive test result.

pLDH if present in the specimen will bind to the pLDH-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-pLDH antibody forming a burgundy colored Pan band, indicating a plasmodium positive test result. In the absence of Pf band, a positive test result for any of the other three plasmodia can be recommended.

Absence of any test bands (Pan and Pf) 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- chicken IgY / chicken IgY-gold conjugates 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.

【MAIN COMPONETS】

1. Individually sealed foil pouches containing:
2. One cassette device
3. One desiccant
4. 5 µL Blood transfer devices (sample loops, mini plastic droppers or capillary tubes)
5. Blood Lysis buffer (1 bottle, 10 mL)
6. One package insert (instruction for use)

【STORAGE CONDITIONS AND EXPIRY DATE】

All reagents are ready to use as supplied. Store unused test device unopened, preferably at 2℃-30℃. Do not expose the kit over 40 Do not freeze the kit. The positive and negative controls should be kept at 2℃-8℃ or the temperature recommended. 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 if it is stored at 2℃-30℃.