Malaria Pf and Pan Rapid Test

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Description

Intended Use

Malaria Pf and Pan Rapid Test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of histidine-rich protein II (HRP-II) antigen of Plasmodium falciparum and common Plasmodium lactate dehydrogenase (pLDH) of Plasmodium species in human whole blood. The test can also distinguish malarial infections between P. falciparum (P.f) and non-P.f Plasmodium species. Malaria Pf and Pan Rapid Test is intended for professional use, only for diagnostic test and reactive samples should be confirmed by a supplementary assay such as microscopic examination of thin blood smear.

Materials

● Individually packed test devices

● Package insert

● Disposable specimen pipettes

● Buffer

Test Procedure

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within an hour.

2. Place the test device on a clean and level surface. Transfer the specimen by a pipette or a disposable dropper:

● To use a Pipette (which is not provided in the kit): Transfer 10 L 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 ② below).

● To use a Disposable dropper (provided in the kit): Hold the dropper vertically; draw the specimen up to the Fill Line as shown in illustration ① below. Transfer the entire 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 ② below).

3. Read the result at 15 minutes. Do not interpret the result after 20 minutes.

Interpretation of Results

	P.f+Pan Positive: P.f+Pan Positive result including two conditions below: 1. P. falciparum infection 2. P. falciparum and Non-P.f Plasmodium species mixed infection. One line appears in the control region, one line appears in Pan region and one line appears in P.f region.
	Pan Positive: Pan positive result indicates Non-P.f Plasmodium species infection. One line appears in the control region, one line appears in Pan region.
	P.f Positive: P.f positive result indicates P. falciparum infection. One line appears in the control region, and one line appears in P.f region.
	Negative: Only one band appears in the control region (C), and no band appears either in the Pan region or P.f region.
	Invalid: No red band appears in the control region (C), whether a test band(s) is present or not. Repeat invalid tests with a new sample, new test device and reagent. Insufficient sample volume, inaccurate operating procedure or expired tests may yield an invalid result. Contact your local distributor if the problem continues.