Malaria Pf Pan Ag Rapid Test Kit

Instruction for Use

A lateral flow immunochromatographic assay for the qualitative simultaneous detection and differentiation of HRP-2 (Histidin- rich protein-2) specific to Plasmodium falciparum (P.f) and pLDH (Plasmodium lactate dehydrogenase) specific to Plasmodium species (Pan) in human whole blood.

Principle

The Malaria P.f. /Pan Rapid Test Cassette(Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f., P.v., P.o. and P.m. antigens in whole blood. The membrane is pre-coated with anti-HRP-II antibodies and anti-Aldolase antibodies. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated on the test cassette. The mixture then migrates upward on the membrane by capillary action, reacts with anti-Histidine-Rich Protein II (HRP-II) antibodies on the membrane on P.f. Test Line region and with anti-Aldolase antibodies on the membrane on Pan Line region. If the specimen contains HRP-II or Plasmodium-specific Aldolase or both, a colored line will appear in P.f. line region or Pan line region or two colored lines will appear in P.f. line region and Pan line region. The absence of the colored lines in P.f. line region or Pan line region indicates that the specimen does not contain HRP-II and/or Plasmodium-specific Aldolase. To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Assay Procedures

Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened.

1. Take off the outer packing, place the cassette on a clean and level surface with the sample window up.

2. Use a pipette: To transfer 5μL of whole blood to the sample well "S", then add 4 drops (160μL) of sample buffer into the buffer well "D" and start the timer.

Use a disposal dropper: Hold the dropper vertically, draw the sample up to the Fill Line (Marked on the dropper, approximately 5μL), transfer the sample into the sample well "S", then add 4 drops(160μL) of sample buffer into the buffer well "D" and start the timer.

Interpretation of Results

Positive: Three distinct red lines appear in the control region (C), the T1 test region (T1) and the T2 test region (T2), indicating the P. falciparum, and P. vivax or P. ovale or P. malariae or mixed infection.

Positive: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the T1 test region (T1), indicating the P. vivax or P. ovale or P. malariae or mixed infection.

Positive: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the T2 test region (T2), indicating the P. falciparum infection.

Negative: One red line appears in the control region(C). No red or pink line appears in the test region (T1 and T2).

Invalid: No red bands appear or control line fails to appear, indicating that the operator error or reagent failure.