Malaria PF/PV/Pan Antigen Rapit 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.

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.