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JAMA. 2007;298:1394.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

MMWR. 2007;56:686

On June 13, 2007, the Food and Drug Administration approved BinaxNOW® Malaria (Inverness Medical Professional Diagnostics, Scarborough, Maine), the first malaria rapid diagnostic test (RDT) authorized for use in the United States. Malaria RDTs, which detect circulating malaria-specific antigens, already are available in other countries and often are used in settings where malaria microscopy is not available. In the United States, use of the RDT can decrease the amount of time required to determine whether a patient is infected with malaria.

BinaxNOW® Malaria is approved for use by hospital and commercial laboratories, not by individual clinicians or by patients themselves; however, the manufacturer is planning to seek a Clinical Laboratory Improvement Amendments waiver for point-of-care use by clinicians. The RDT detects two different malaria antigens: HRP2, which is specific to Plasmodium falciparum, and a malaria aldolase found in all four human species of malaria parasites. Although the test . . . [Full Text of this Article]