Malaria P.f./P.v./Pan Rapid Test Cassette (Whole Blood)

A rapid test for the qualitative detection of circulating antigens of P. falciparum (P.f.), P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.) in whole blood. For professional in vitro diagnostic use only.

Applications: 

The Malaria P.f./P.v./Pan Rapid Test Cassette (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of four kinds of circulating Plasmodium falciparum (P.f.), P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.) in whole blood.

Description: 

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./Pan Rapid Test Cassette (Whole Blood) is a rapid test to qualitatively detect the presence of P. falciparum - specific HRP-II, P. vivax (P.v.) and four kinds of circulating plasmodium falciparum (P.f.), P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.). The test utilizes colloid gold conjugate to selectively detect P.f-specific, P. vivax (P.v.) and Pan-malarial antigens (P.f., P.v., P.o. and P.m.) in whole blood.

How to 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.
· Use a pipette: To transfer 5 μl of whole blood to the specimen well (S), then add 3 drops of buffer (approximately 180 μl) to the buffer well (B) and start the time.
· Use a disposal specimen dropper: Hold the dropper vertically; draw the specimen up to the upper end of the nozzle as shown in illustration below (approximately 5 μl).
Transfer the specimen to the specimen well (S), then add 3 drops of buffer (approximately 180 μl) to the buffer well (B) 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.

INTERPRETATION OF RESULTS 
(Please refer to the illustration above)
POSITIVE:* Two or Three or Four distinct colored lines appear.
P. falciparum Infection (Either of the results):
One line appears in the control region, one line appears in P.f. line region.
One line appears in the control region, one line appears in P.f. line region and one line appears in Pan line region.
P. vivax Infection (Either of the results): 

One line appears in the control region, one line appears in P.v. line region.
One line appears in the control region, one line appears in P.v. line region and one line appears in Pan line region.
Non-P. falciparum/ Non-P. vivax Infection:
One line appears in the control region, one line appears in Pan line region. Mixed malaria infection:
One line appears in the control region, one line appears in P.f. line region, and one line appears in P.v. line region.
One line appears in the control region, one line appears in P.f. line region, one line appears in P.v. line region and one line appears in Pan line region.
*NOTE: The color intensity of P.f., P.v. or Pan Test lines may vary depending on the concentration of antigens, viz., HRP-II, P.v. LDH or Plasmodium-specific LDH present in the specimen.
NEGATIVE: Only one colored line appears in the control region.
INVALID: 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 local distributor.