INTENDED USE
The one step Malaria(p.f/p.v) 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 P.f HRP-II and P. vivax specific pLDH which 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.

 

Specification:

 

Features: high sensitivity, simple & easy to use and the result is accurate
Formats: 3.0mm or 4.0mm cassette; 2.5mm, 3mm, 4mm strip

Specimen: whole blood

 Read Time: in 15minutes

Accuracy: >99%

Storage: Room temperature

Shelf life: 24-36 months from date of manufacture
Packing details:    Cassette: 40pcs/bag, 70bags/Carton

Place of origin: China

Shipping: By  sea

 

 Interpration of testing results:

 

POSITVE:

Control line and at least one test line appear on the membrane. The appearance of T2 test line indicates a p.f HRP-II positive result.
The appearance of T1 test line indicates a p. vivax specific pLDH positive result. And pf both t1 and t2 line appear, it indicates that both p.f and p.v are positive. The lower the antigen concentration is, the weaker the result line is.

 Only the black control band appears on the membrane. The absence of a test band indicates negative results.
INVALID:

 The control line fails to appear.

 

Note: It is normal to have a slightly lightened control band with very strong positive samples as long as it is distinctly visible