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Intended use
For the rapid qualitative detection of malaria HRP2 (histidine-rich protein 2) (P .falciparum) and
plasmodium lactate dehydrogenase (pLDH) (P .falciparum, P.vivax, and P malariae) in human blood
as an aid in the diagnosis of malaria infection.
Summary
Malaria is a serious parasitic disease characterized by fever, chills and anemia and is caused by a
protozoan parasite that is transmitted to humans through biting of infected Anopheles mosquitoes.
There are four types of human malariae: Plasmodium falciparum, P. vivax, P. ovale and P. malariae.
In humans after an infected mosquito biting, the parasites (called sporozoites) migrate to the liver
where they mature and re-released into blood stream, infecting red blood cells.
Malaria infection occurs in more than 90 countries worldwide, but is mostly prevalent in sub-
Saharan Africa. It is estimated that there are over 500 million malaria case and 2.7 million malaria-
caused deaths per year.
Materials required
The following materials are needed but not provided:
1) Pair of disposable gloves
2) Timer
3) Sharps box
4) Pencil or pen
5) Sterile gauze or cotton
Test Procedure
1) Put on a new pair of gloves.
2) Write the patient’s name on the test.
3) Clean the area to be pierced using an alcohol pad.
4) Squeeze the end of the fingertip and pierce the cleaned area of the fingertip using a lancet
provided or venipuncture. Discard the lancet in the sharp box.
5) Wipe out the first drop of blood with sterile gauze or cotton.
6) Collect the blood sample (5ul) using a pipette provided or micropipette.
7) Add 5ul of whole blood into the “S” well.
8) Add 60ul assay buffer solution (3 drops for vial type or 2 drops for bottle type) into the “A”
well. Start the timer.
3) PAN Positive
The presence of two color lines (one line in the “C” area and another line in the “2” area)
indicates a positive result for P .falciparum, P. vivax, P .ovale or P .malariae.
4) P. falciparum positive
The presence of two lines (one line in the “C” area and another line in the “1” area)
indicates a positive result for P. falciparum.
5) Mixed infection
The presence of three color lines (lines in the “C” area, “2” and “1” area) indicates a
positive result of mixed infection for P .falciparum and others (P. vivax, P.ovale or
P.malariae).