Tri-line Malaria pf/pv antibody Home Testing kits, individual package, whole blood test 4mm cassette full kit

Product Name: Malaria P.f & P.v antibody Home Testing kits

INTENDED USE: Malaria P.f & P.v Ab test is an immunochromatographic (rapid) test for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA) specific to Plasmodium falciparum and Plasmodium vivax simultaneously in human serum or plasma or whole blood.

SUMMARY:

Malaria is a serious, sometimes fatal, parasitica disease characteristic by fever, chills and anemia and is caused by a parasite that is transmitted from one human to another by the bite of infected anopheles mosquitoes. Malaria pf/pv Ab test is an immunochromatographic test for the qualitative detection of antibodies of all isotypes specific to pf and pv simultaneously in human serum or plasma or whole blood.

TEST PRINCIPLE

A capture monoclonal antibody is immobilized on the membrane within the cassette. The red blood cells are lysed releasing Pf. HRP11 and P. vivax specific pLDH which binds selectively to this antibody as the blood flows along the strip inside the cassette. The signal reagent is coated with specific antibodies, which bind with the antibody-antigen complex, producing a black line. The presence of an upper black line (the control line) demonstrates the test has been performed correctly.

INTERPRETATION OF RESULTS

Malaria P.f Positive
The control line and Malaria P.f line (T1) are visible in the result window. The test is positive for Malaria P.f.

Malaria P.v Positive
The control line and Malaria P.v line (T2) are visible in the result window. The test is positive for Malaria P.v.

Malaria P.f and Malaria P.v Positive

The control line, Malaria P.f (T1) and Malaria P.v (T2) lines are visible in the result window. The test is positive for Malaria P.f and Malaria P.v.

Negative
The control line is the only line visible in the result window. No Malaria P.f or Malaria P.v has been detected.

Invalid
If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

Performance Study

The following data was generated from previously frozen whole blood samples and was determined by correlation to standard thick and thin smear microscopic examination with discrepancies evaluated via PCR. Retrospective study results are summarized below: