Malaria antigen detection kit is designed as a simple, rapid, qualitative and cost effective method for the simultaneous detection and differentiation of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) in human whole blood or fingertip whole blood. This device is intended to be used as a screening test and used for the auxiliary diagnosis of P. f and P.v infection.
The Malaria antigen test kit (Lateral chromatography) is based on the principle of microsphere double antibody sandwich method to rapid qualitative determination of P.f/ P.v antigen in human whole blood or fingertip whole blood. The microsphere is marked in anti-HRP-2 antibody (specific to P.f) on the T1 band and anti-PLDH antibody(specific to P.v) on the T2 band, and anti-mouse IgG polyclonal antibody is coated on quality control area (C). When the sample contains malaria HRP2 or pLDH antigen and the concentration is higher than the minimum detection limit, which are allowed to react with the colloidal microsphere coated with Mal-antibody to form antibody-antigen complex. The complex then moves laterally on the membrane and respectively binds to the antibody immobilized on the membrane producing a pink line on the test region, which indicates a positive result. The presence of the control line demonstrates the test has been performed correctly regardless the presence of P.f/ P.v antigen.
|Test Cassette||1 test||25 tests|
|Sample Diluent||1 bottle||1 bottle|
|Dropper||1 piece||25 PCS|
|Instructions For Use||1 piece||1 piece|
|Certificate of Conformity||1 piece||1 piece|
Collect human whole blood or fingertip blood properly.
1. Remove an extraction tube from the kit and a test box from the film bag by tearing the notch. Put it on the horizontal plane.
2. Open the inspection card aluminum foil bag. Remove the test card and place it horizontally on a table.
3. Add 60μL sample dilution solution immediately. Start counting.
20 mins later, read the results visually. (Note: do NOT read the results after 30 minutes!)
The presence of two colored bands ("T1" and "C") within the result window indicates P.f Positive.
The presence of two colored bands ("T2"and "C") within the result window indicates P.v.
3.Positive. P.f and P.v Positive
The presence of three colored bands ("T1","T2"and "C") within the result window may indicates mixed infection of P. f and Pan.
The presence of only control line(C) within the result window indicates a negative result.
If no band appears in the control region(C), the test results are invalid regardless of the presence or absence of line in the test region(T). The direction may not have been followed correctly or the test may have deteriorated It is recommended that repeat the test using a new device.
|Product Name||Cat. No||Size||Specimen||Shelf Life||Trans. & Sto. Temp.|
|Malaria HRP2/pLDH (P.f/P.v) Antigen Rapid Test Kit (Lateral chromatography)||B013C-01||1test/kit||Whole Blood/Fingertip Blood||18 Months||2-30℃ / 36-86℉|