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.
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.
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.
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.
Contact Rebecca Yan