Malaria Pf/Pv Antigen Assay Kit (Colloidal Gold)

【Product Specification】

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

【INTENDED USE】

The Malaria Pf/Pv Antigen Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) and vivax (Pv) 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/Pv Antigen Assay Kit (Colloidal Gold) must be confirmed with alternative testing method(s) and clinical findings.

【PRINCIPLE OF THE PROCEDURE】

The Malaria Pf/Pv Antigen Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay. The strip test components consist of: 1) a burgundy colored conjugate pad containing mouse anti-Pv-LDH antibody conjugated with colloidal gold (Pv-LDH-gold conjugates) and mouse anti-pHRP-II antibody conjugated with colloidal gold (pHRP-II-gold conjugates), 2) a nitrocellulose membrane strip containing two test bands (Pv and Pf bands) and a control band (C band). The Pv band is pre-coated with another mouse anti-Pv-LDH specific antibody for the detection of Pv infection, 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-mouse IgG.

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 antigens, which migrate by capillary action across the strip held in the cassette. Pv-LDH if present in the specimen will bind to the Pv-LDH-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-Pv-LDH antibody, forming a burgundy colored Pv band, indicating a Pv positive test result.

Alternatively, 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.

Absence of any test bands 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-mouse IgG / mouse IgG (anti-Pv-LDH and anti-pHRP-II)-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】

Individually sealed foil pouches containing:

One cassette device
One desiccant
5 µL Blood transfer devices (sample loops, mini plastic droppers or capillary tubes)
Blood Lysis buffer (1 bottle, 10 mL)
One package insert (instruction for use)