Intented Use:
Compass CLEAR PATH ™ Malaria P.f/P.v Rapid Test is a lateral flow immunochromatographic assay for the qualitative differential detection of P. falciparum specific histidine rich protein-2 (P.f-HRP-2) and P. vivax specific pLDH in human whole blood for professional use.
Test Principal:
The test is a single-use cassette device in a plastic housing. It contains a test strip, which is composed of an absorbent pad, a test membrane, a conjugate pad, and a sample pad. The membrane strip contains two test lines and one control line; immobilized antibody for test line and for control line. A conjugated pad is placed in between sample pad & membrane. A conjugated pad containing antibody is link with gold particles. The device is sealed in a pouch with a silica gel & dropper. Malaria P.f /P.v Rapid Test is a lateral flow chromatographic immunoassay. The strip test contains a pre-coated membrane strip, which consist a colored conjugate pad containing rabbit anti-P.v-LDH antibody conjugated with colloidal gold (Pv-LDH-gold conjugates) and rabbit anti-pHRP-II antibody conjugated with colloidal gold (pHRP-II-gold conjugates), and a nitrocellulose membrane strip containing two test bands “P.v” & “P.f” and a control band “C”. The “P.v” band is pre-coated with monoclonal antibody specific to anti-P.v-LDH for the detection of P.v infection, the P.f band is pre-coated with monoclonal anti-pHRP-II antibodies for the detection of P.f infection, and the C band is coated with goat anti-rabbit IgG.
During the assay, an adequate volume of the blood specimen is dispensed into the sample well (S) of the test cassette, and an assay 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. P.v-LDH if present in the specimen will bind to the P.v-LDH-gold conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-P.v- LDH antibody, forming a colored P.v band, indicating a P.v 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 colored P.f band, indicating a P.f positive test result. Absence of the P.f and P.v bands in device suggests a negative result. The device Indicating control line “C” indicating proper functioning of test device and proper procedure has been followed.
Available in packs of: 1Test, 5Test, 10Test, 20Test, 25Test, 30Test, 50Test, 100Test