One Step Rapid Test Lateral Flow Assay Malaria P.f. Rapid Test Dipstick ( Whole Blood )

A rapid test for the qualitative detection of circulating plasmodium falciparum (P.f.) in whole blood CE certified

Applications:

The Malaria P.f. Rapid Test Dipstick (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating plasmodium falciparum in whole blood.

Description:

Malaria is caused by a protozoan which invades human red blood cells.¹ 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 theworld'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.² 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 suchas 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. Rapid Test Dipstick (Whole Blood) is a rapid test to qualitatively detect the presence of the P.f. antigen.

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 Dipstick from the sealed               pouch and use it as soon as possible. Best results will be obtained if the assay is performed within             one hour.

       2.Transfer the whole blood to the specimen tube by a pipette or a dropper.

       2.1 To use a pipette: To transfer 10mL of whole blood to the specimen tube, then add 3 drops of            buffer (approximately 180 mL),and start the timer.

       2.2 To use a Disposable Specimen Dropper: Hold the dropper vertically, draw the specimen up to            the Fill Line as shown in illustration below (approximately 10 mL). Transfer the specimen to the                specimen tube, then add 3 drops of buffer (approximately 180 mL), and start the timer.

       3.With arrows pointing toward the specimen, immerse the test Dipstick vertically in the specimen and             start the timer. Do not pass the maximum line (Max) on the test Dipstick when immersing the                       Dipstick.

       4.Wait for the colored line(s) to appear. Read results at 10minutes. Do not interpret the result after               20 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of antigen, vis.,HRP-II present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.