Malaria P.f./Pan Antigen Rapid Test

INTENDED USE

The Malaria P.f/Pan Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in human whole blood specimen.

MATERIALS

Materials Provided

Materials Required but Not provided

PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

3. 1. Remove the test device from the foil pouch and use it as soon as possible. Best resultswill be obtained if the assay is performed within one hour.
4. 2. Place the test device on a clean and level surface. Transfer the specimen by a pipette or a pipette:
   • To use a Pipette: Transfer 10 mL of whole blood to Well-1 (W1) of the test device, then add 3 full drops of buffer to Well-2 (W2), and start the timer. (See illustration ① below). Avoid trapping air bubbles in W1. At the end of 5 minutes, add 1 full drop of buffer to the W1 (See illustration ③ below).
   • To use a Disposable Specimen Pipette: Hold the pipette vertically; draw the specimen up to the Fill Line as shown in illustration ① Transfer the specimen to W1 of the test device, then add 3 full drops of buffer to W2 and start the timer. Avoid trapping air bubbles in W1. At the end of 5 minutes, add 1 full drop of buffer to W1 (See illustration ③ below).
5. 3. Wait for the colored line(s) to appear. The result shouldbe read at 15 minutes.Do not interpret the result after 20 minutes.
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7. INTERPRETATION OF RESULTS

   (Please refer to the illustration above)

   POSITIVE:* Two or Three distinct colored lines appear. 

   1. falciparumor mixed malaria infection：one line appears in the control region, one line appears in Pan 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 Pan line region.

   *NOTE: The color intensity of P.f or Pan test lines may vary depending on the concentration of antigens, viz., HRP-II or Aldolase 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.

   LIMITATIONS OF THE TEST

   1. 1. The Malaria P.f/Pan Antigen Rapid Testis for in vitro diagnostic use only. This test should be used for the detection of f, P.v, P.o, P.m antigens in whole blood specimens only. Neither the quantitative value nor the rate of increase in P.f, P.v, P.o, and P.m concentration can be determined by this qualitative test.
   2. 2. The Malaria P.f/Pan Antigen Rapid Testwill only indicate the presence of antigens of Plasmodium sp. (f, P.v, P.o, P.m) in the specimen and should not be used as the sole criterion for the diagnosis of malaria infection.
   3. 3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
   4. 4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of malaria infection.
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