Malaria Rapid Test

Product information

The Malaria Rapid Test is a rapid qualitative assay for the detection of circulating antigens of P. falciparum (P.f.) and P. vivax (P.v.) in whole blood.

Advantages of Malaria test

• Easy to perform
• No complex sample collection needed
• Accurate test result

General information

Malaria is caused by a protozoan which invades human red blood cells.1 Malaria is one of the world’s most prevalent diseases. According to the WHO, the worldwide prevalence of the disease is estimated to be 300-500 million cases and over 1 million deaths each year. Most of these victims are infants, young children. Over half of the world’s population lives in malarious areas.

Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century. The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopist and use of proven and defined procedures, frequently present the greatest obstacles to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology.

The Malaria P.f./P.v. Rapid Test Cassette(Whole Blood) is a rapid test to qualitatively detect the presence of P. falciparum – specific HRP-II and P. vivax (P.v.). The test utilizes colloid gold conjugate to selectively detect P.f-specific and P. vivax (P.v.)-specific antigens in whole blood.

The Malaria P.f. /P.v. Rapid Test Cassette(Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f. and P.v. antigens in whole blood. The membrane is pre-coated with anti-HRP-II antibodies and anti-pLDH 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-pLDH antibodies on the membrane on P.v. Line region. If the specimen contains HRP-II or Plasmodium-specific P. vivax LDH or both, a colored line will appear in P.f. line region or P.v. line region or two-colored lines will appear in P.f. line region and P.v. line region. The absence of the colored lines in P.f. line region or P.v. line region indicates that the specimen does not contain HRP-II and/or Plasmodium-specific P. vivax LDH. 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.

Test procedure

1. Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
2. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
3. Place the cassette on a clean and level surface.
4. For Whole Blood specimen: Use a pipette: To transfer 5μL of whole blood to the specimen well, then add 3 drops of buffer (approximately 180μL).
5. Use a disposal specimen dropper: Hold the dropper vertically, draw the specimen up to the Fill Line as shown in illustration below (approximately 5μL). Transfer the specimen to the specimen well, then add 3 drops of buffer (approximately 180μL), and start the timer.
6. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

Interpretation of the results

Negative result: Only one colored line appears in the control region (C).

Positive result: Two or Three distinct colored lines appear.

1. falciparum or mixed malaria infection: one line appears in the control region; one line appears in P.v. line region and one line appears in P.f. line region.
2. falciparum infection: one line appears in the control region, and one line appears in P.f .line region.

Non-falciparum Plasmodium species infection: one line appears in the control region and one line appears in P.v. line region.

*NOTE: The color intensity of P.f. or P.v. test lines may vary depending on the concentration of antigens, viz., HRP-II or P. vivax LDH present in the specimen.

Invalid result: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your supplier.