Malaria P.f./P.v. Rapid Test Cassette

【SUMMARY】
Malaria is caused by a protozoan which invades human red blood cells. 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 antigensin whole blood.

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