Malaria Diagnosis (U.S.

) – Rapid Diagnostic Test

A Rapid Diagnostic Test (RDT) is an alternate way of quickly establishing the diagnosis of
malaria infection by detecting specific malaria antigens in a person’s blood. RDTs have
recently become available in the United States.

Technique
A blood specimen collected from the patient is applied to the sample pad on the test card
along with certain reagents. After 15 minutes, the presence of specific bands in the test
card window indicate whether the patient is infected with Plasmodium falciparum or one
of the other 3 species of human malaria. It is recommended that the laboratory maintain a
supply of blood containing P. falciparum for use as a positive control.

Advantages
High-quality malaria microscopy is not always immediately available in every clinical
setting where patients might seek medical attention. Although this practice is
discouraged, many healthcare settings either save blood samples for malaria microscopy
until a qualified person is available to perform the test, or send the blood samples to
commercial or reference laboratories. These practices have resulted in long delays in
diagnosis. The laboratories associated with these health-care settings may now use an
RDT to more rapidly determine if their patients are infected with malaria.

BinaxNOW® Malaria Test, the only available RDT for malaria in the United States.
Disadvantages
The use of the RDT does not eliminate the need for malaria microscopy. The RDT may not
be able to detect some infections with lower numbers of malaria parasites circulating in
the patient’s bloodstream. Also, there is insufficient data available to determine the ability
of this test to detect the 2 less common species of malaria, P. ovale and P. malariae .
Therefore all negative RDTs must be followed by microscopy to confirm the result.

In addition, all positive RDTs also should be followed by microscopy. The currently
approved RDT detects 2 different malaria antigens; one is specific for P. falciparum and
the other is found in all 4 human species of malaria. Thus, microscopy is needed to
determine the species of malaria that was detected by the RDT. In addition, microscopy is
needed to quantify the proportion of red blood cells that are infected, which is an
important prognostic indicator.

(https://www.youtube.com/watch?v=TZTH_bucaVI&feature=youtu.be)

Tra i n i n g (https://www.youtube.com/watch?v=TZTH_bucaVI&feature=youtu.be)

On June 13, 2007, the FDA approved the first rapid diagnostic test (RDT) for use in
the United States, the Binax NOW Malaria. This RDT is approved for use by
hospital/commercial laboratories, not by individual clinicians or by patients
themselves. This video (https://www.youtube.com/watch?v=TZTH_bucaVI&
feature=youtu.be) provides guidance regarding the test procedure and results
interpretation.

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Page last reviewed: April 26, 2018
Page last updated: April 26, 2018
Content source: Global Health (/globalhealth) – Division of Parasitic Diseases and Malaria