Malaria PF/Pan Rapid Test Kit on Antigens of Whole Blood Sample

Basic Info

Model NO.	MALP-DW02
Shelf Life	24 Months
Certificate	CE
Usage	Professional Used
Transport Package	40tests/Box
Specification	1000tests/Carton
Trademark	Dewei
Origin	China

Product Description

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 whole blood.For professional use only.PRINCIPLEThe Malaria P.f/Pan Rapid Test (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f, P.v, P.o and P.m antigens in whole blood. The membrane is pre-coated with anti-HRP-II antibodies and anti-Aldolase antibodies. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated on the test strip. 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-Aldolase antibodies on the membrane on Pan Line region. If the specimen contains HRP-II or Plasmodium-specific Aldolase or both, a colored line will appear in P.f line region or Pan line region or two colored lines will appear in P.f line region and Pan line region. The absence of the colored lines in P.f line region or Pan line region indicates that the specimen does not contain HRP-II and/or Plasmodium-specific Aldolase. 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.WARNINGS AND PRECAUTIONSImmunoassay for in vitro diagnostic use only.Do not use after expiration date.The test should remain in the sealed pouch until use.The used test should be discarded according to local regulations.STORAGE AND STABILITYThe kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.The test must remain in the sealed pouch until use.Keep away from direct sunlight, moisture and heat.Do not freeze.Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results. OPERATIONAllow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.2. Place the test device on a clean and level surface.Transfer the specimen by a pipette or a disposable specimen pipette:

• To use a Pipette: Transfer 5 mL of whole blood to Well-1 (W1) of the test device, then add 3~4 full drops of buffer to Well-2 (W2), and start the timer. (See illustration below). Avoid trapping air bubbles in W1.
• To use a Disposable Specimen Pipette: Hold the pipette vertically; draw the specimen up to the Fill Line as shown in illustration below. Transfer the specimen to W1 of the test device, then add 3~4 full drops of buffer to W2 and start the timer. Avoid trapping air bubbles in W1.

3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTSPOSITIVE:* Two or Three distinct colored lines appear. P. falciparum or 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.P. 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.

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