Malaria Pf/Pan Ag Rapid Test
For the qualitative detection of Malaria Pf/Pan antigen in whole blood
Malaria PF/PV Antigen Rapid Test Kit Home Use Accurate Malaria PF/PV Infectious Disease Fast Diagnostic Cassette
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.
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.
Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).
Assay Procedure
Step 1:Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Step 3: Be sure to label the device with specimen’s ID number.
Step 4: Apply 5ul whole blood into the sample well.Then add 4 drops of Sample Diluent. After 5min, add 2 drops again.
Step 5: Set up the timer.
Step 6: Results can be read in 30 minutes. Positive results can be visible in as short as 1 minute.
Interpretation of Result
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.
Pan 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
Summary and Explanation of The Test
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 distribution 1. 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.
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