17 July 2007

FDA Clears First Rapid Diagnostic Test for Malaria

In an “FDA News” release posted on the FDA website (www.fda.gov) June 26, 2007 the US Food and Drug Administration (FDA) announced that they had cleared for marketing in the laboratory setting the “first authorized U.S. rapid test for malaria”. In the July 13 issue of the CDC’s Morbidity and Mortality Weekly report (MMWR) (2007:56 (27): 686) a “Notice to Readers: Malaria Rapid Diagnostic Test” (RDT) appears that describes in a one page summary this new malaria test known as “Binax NOW Malaria (Inverness Medical Innovations, Scarborough, Maine).

This new rapid malaria test (RDT) can provide results in 15 minutes following placement of several drops of whole blood on a dipstick. Of note, this test is intended for laboratory use only by hospital and commercial laboratories and not by individual clinicians or patients. According to the FDA, “Results still need to be confirmed using standard microscopic evaluation” for malaria (plasmodium) protozoan parasites. The FDA reported that the “Binax NOW test was 95 percent accurate compared with standard microscopic diagnosis in a multi-center study outside the United States in areas where malaria is prevalent”.

The Centers for Disease Control and Prevention (CDC) MMWR 13 July publication adds that this malaria rapid test 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 can identify P. falciparum, it cannot distinguish between Plasmodium vivax, Plasmodium ovale, or Plasmodium malariae or detect mixed infections”.

In an unrelated recent noteworthy publication for clinicians on malaria, in the May 23/30, 2007 issue of the Journal of the American Medical Association (JAMA) Kevin Griffith and colleagues provide a systematic review on the treatment of malaria in the United States. They note that artemisinin anti-malaria drugs “are not yet available” in the USA.

Artemisinin anti-malarial drugs are available in some nations outside the USA, and combination therapy using artemisinins in certain clinical settings has been discussed in detail by the World Health Organization (WHO) in documents posted on their website (www.who.int).

Daniel R. Lucey, MD, MPH

Director, Center for Biological Counterterrorism and Emerging Diseases

EROne institutes, Department of Emergency Medicine

Washington Hospital Center, Washington, DC

Co-Director, M.S. Graduate program for Biohazardous Threat Agents and Emerging Infectious Diseases, Department of Microbiology and Immunology

Georgetown University Medical Center

Website for this posting: www.BePast.org e-mail: Daniel.R.Lucey@Medstar.net