Malaria Pf/Pv Antibody Detection Test Device (Serum/Plasma/Whole Blood)

Intended Use

For the rapid qualitative determination of Malaria pf/pv antibody in human blood as an aid in the diagnosis of Malaria infection. This test is intended for professional use and is a preliminary screening test and final diagnosis should be based after examination with other assays.

Summary

Directions for Use:

Allow test device, buffer, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing. 
 
1. Add 10 µL of serum, plasma, or 20 µl of whole blood to the sample well "S".
 
2. Add 3 drops of the assay chase buffer to the sample well.
 
3. Interpret test results in at 20 minutes. 
 
NOTE: Do not interpret test result after 45 minutes.

Interpretation of Results:

1) P. falciparum Positive reaction The presence of a color band at the 1 indicates a positive result for P. falciparum. 
 
2) P. vivax Positive reaction  The presence of a color band at the 2 indicates a positive result for P. vivax.
 
3) Negative reaction  The presence of only one band at the C indicates a negative result.
 
4) Invalid

Limitations 

The test is limited to the detection of antibodies to Malaria both Plasmodium falciparum and Plasmodium vivax simultaneously. Although the test is very accurate in detecting antibodies to Malaria pf/pv, a low incidence of false results can occur. Other clinically available tests are required if questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated