Evaluation of a colorimetric PCR-based assay to diagnose Plasmodium falciparum malaria in travelers

New diagnostic tests are needed to facilitate the diagnosis of Plasmodium f alciparum malaria in the returned traveler. We performed a blinded evaluati on of a nonisotopic colorimetric PCR-based assay (Digene SHARP Signal Syste m) and compared the results with those obtained by microscopy and nested PC R for the detection of P. falciparum malaria in 150 febrile travelers. By u sing nested PCR as the reference standard, the colorimetric assay had a sen sitivity of 100% and a specificity of 95.4% far the detection of P. falcipa rum, This PCR-based nonisotopic assay is a rapid, sensitive, and specific m ethod for the detection of falciparum malaria in returned travelers.