Malaria Pf/Pv Ag Rapid Test Cassette WB

Malaria Pf/Pv Ag Rapid Test

INTENDED USE

The Malaria Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax, P. ovale, or P.  Malariea antigen in whole blood. 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 Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY

Malaria is a mosquito-borne, hemolytic, febrile illness that infects over 200 million people and kills more than 1 million people per year. It is caused by four species of Plasmodium: P. falciparum, P. vivax, P.ovale, and P. malariae. These plasmodia all infect and destroy human erythrocytes, producing chills, fever, anemia, and splenomegaly. P. falciparum causes more sever disease than the other plasmodial species and accounts for most malaria deaths. P. falciparum and P. vivax are the most common pathogens, however, there is considerable geographic variation in species distribution1. Traditionally, malaria is diagnosed by the demonstration of the organisms on Giemsa stained smears of peripheral blood, and the different species of plasmodium are distinguished by their appearance in infected erythrocytes1. The technique is capable of accurate and reliable diagnosis, but only when performed by skilled microscopists using defined protocols2, which presents major obstacles for the remote and poor areas of the world.

The Malaria Rapid Test is developed for solving these above obstacles. It detects the antibodies generated in serum or plasma in response to the infection of plasmodium. Utilizing the Pf. specific antigen (HRP-II) and pan-malaria antigen (aldolase), the test enables simultaneous detection and differentiation of the infection of P.falciparum and or P. vivax, ovale, and malariae3-5, by untrained or minimally skilled personnel, without laboratory equipment.

PRINCIPLE

The Malaria Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing mouse anti-pHRP-II antibody conjugated with colloid gold (pHRP II-gold conjugates) and mouse anti-pLDH antibody conjugated with colloid gold (pLDH-gold conjugates), 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 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 T2 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. 

INTERPRETATION OF RESULTS  (Please refer to the illustration above)

Negative: If only the C band is present, the absence of any burgundy color in the both T bands (T1 and T2) indicates that no plasmodium antigens are detected. The result is negative.                     

Positive:

Pf positive: In addition to the presence of C band, if only T2 band is developed, the test indicates for the presence of pHRP-II antigen. The result is Pf positive.

Pv positive: In addition to the presence of C band, if only T1 band is developed, the test indicates for the presence of pLDH antigen. The result is either Pv, Pm, or Po positive.

Mixed positive: In addition to the presence of C band, both T1 and T2 bands are developed, the test indicates for the presence of both pHRP-II and pLDH. The result is positive.

Note: Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.

Invalid: If no C band is developed, the assay is invalid regardless of any burgundy color in the T bands as indicated below. Repeat the assay with a new device.

Rebecca Yan