CareStart TM Malaria Rapid Test

HRP2/pLDH (Pf/PAN) Combo

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.

Warning and precautions

1) Test kit is for in vitro diagnostic and professional use only.
2) Read provided instructions for use before using the test kit. Wash hands thoroughly before
and after using a test kit.
3) Wear protective gloves at all time while using the test kits and dispose gloves immediately
after each testing.
4) Do not touch non contaminated areas or objects with gloves on.
5) Change the glove and hands when contacted with potentially infected materials
6) Wear an eye protection, gown and mask all the time while using the test kit.
7) Do routine cleanup using an appropriate disinfectant.
8) Do not eat or smoke while using the test kit.
9) Follow warnings and precautions, test procedure and interpretation of the test result when
using the test kit.
10) Use the test device and necessary components (lancet and alcohol pad) immediately after
opening its package.
11) Dispose wastes in accordance with local regulations.
12) All provided materials are single use. Do not re-use any of the materials.
13) Do not use materials from different lots.
14) Do not use a test device, if the device pouch is compromised.
15) Do not swallow the assay buffer solution.
16) Lancet is sterile. If a lancet cap is loose and/ or damaged, do not use the lancet.
17) Do not use the alcohol pad, if the alcohol pad package is damaged.
18) Observe storage condition indicated on the aluminum pouch and outer package.
19) Do not freeze the test kit but store the test kit in a refrigerator. The test devices need to be
equilibrated to the room temperature prior to use.
20) Do not use the test kit if the indicated expiration date is past.

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.

9) Read result in 20 minutes.

Interpretation of the test result

1) Invalid
 The test is invalid if the line in the “C” area does not appear. If this occurs, the test should
be repeated using a new device.

<Invalid example features>

2) Negative
The presence of only one line in the “C” area indicates a negative result.

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).