INTENDED USE

The one step Malaria(pf./pv.) Test is a two site sandwich immunoassay utilizing whole blood for the detection of P. falciparum specific histidine rich protein-2(pf. HRP-2) and P. vivax specific pLDH.

The test can also be used for specific detection and diffrentation of p.falciparum and P. vivax malaria.

 

PRINCIPLE OF THE PROCEDURE

A capture monoclonal antibody is immobilized on the nitrocellulose strip. The red blood cells are lysed releasing pf. HRP-II and P. vivax specific pLDHwhich binds selectively to this antibody as the blood is wicked up the strip. 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 procedure control line) demonstrate the test has been performed correctly.

 

 

REAGENT AND MATERIALS SUPPLIED

Test cassette/strip individually foil pouched with a desiccant.

Plastic dropper

Buffer

Package insert

MATERIALS REQUIRED BUT NOT SUPPLIED

Positive and negative controls

STORAGE AND STABILITY

The kit must be stored at 2-30°C