Malaria Pf Histidine-Rich Protein II Assay Kit (Colloidal Gold)

【Product Specification】

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

【INTENDED USE】

The Malaria Pf Histidine-Rich Protein II Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay for the qualitative detection of Plasmodium falciparum (Pf) specific protein, Histidine-Rich Protein II (pHRP-II), 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 Histidine-Rich Protein II Assay Kit (Colloidal Gold) must be confirmed with alternative testing method(s) and clinical findings.

【PRINCIPLE OF THE PROCEDURE】

The Malaria Pf Histidine-Rich Protein II Assay Kit (Colloidal Gold) is a lateral flow chromatographic immunoassay. The test strip components consist of: 1) a burgundy colored conjugate pad containing monoclonal anti-pHRP-II antibody conjugated with colloidal gold (pHRP II-gold conjugates), 2) a nitrocellulose membrane strip containing a test band (Pf) and a control band (C). The Pf band is pre-coated with polyclonal anti-pHRP-II antibodies, and the C band is pre-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, a lysis buffer is added to the buffer well (B). The buffer contains a detergent that lyses the red blood cells and releases the pHRP-II antigen, which migrates by capillary action across the strip held in the cassette. pHRP-II if presents in the specimen will bind to the pHRP II-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated polyclonal anti-pHRP II antibodies, forming a burgundy colored Pf band, indicating a Pf positive test result.

Absence of the Pf band 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 (pHRP II–gold conjugates) regardless of the color development on any of the  Pf band. 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)