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Journal of Clinical Microbiology, August 2001, p. 2884-2890, Vol. 39, No. 8
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.8.2884-2890.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Malaria Rapid Diagnostic Devices: Performance Characteristics of the ParaSight F Device Determined in a Multisite Field Study

J. Russ Forney,1,* Alan J. Magill,2 Chansuda Wongsrichanalai,3 Jeeraphat Sirichaisinthop,4 Christian T. Bautista,2 D. Gray Heppner,1 R. Scott Miller,5 Christian F. Ockenhouse,1 Alex Gubanov,6 Robyn Shafer,6 Caroline Cady DeWitt,7 Higinio A. Quino-Ascurra,8 Kent E. Kester,1 Kevin C. Kain,6 Douglas S. Walsh,3 W. Ripley Ballou,1 and Robert A. Gasser Jr.1

Walter Reed Army Institute of Research1 and Walter Reed Army Medical Center,5 Washington, D.C.; Naval Medical Research Center Detachment, Lima,2 and Hospital de Apoyo, Iquitos,8 Peru; Armed Forces Research Institute of Medical Sciences, Bangkok,3 and Vector Borne Disease Control Office #1, Phrabuddhabat, Saraburi,4 Thailand; The Toronto General Hospital and University of Toronto, Toronto, Canada6; and Wilford Hall Medical Center, Lackland Air Force Base, Texas7

Received 16 February 2001/Returned for modification 3 April 2001/Accepted 30 May 2001

Microscopic detection of parasites has been the reference standard for malaria diagnosis for decades. However, difficulty in maintaining required technical skills and infrastructure has spurred the development of several nonmicroscopic malaria rapid diagnostic devices based on the detection of malaria parasite antigen in whole blood. The ParaSight F test is one such device. It detects the presence of Plasmodium falciparum-specific histidine-rich protein 2 by using an antigen-capture immunochromatographic strip format. The present study was conducted at outpatient malaria clinics in Iquitos, Peru, and Maesod, Thailand. Duplicate, blinded, expert microscopy was employed as the reference standard for evaluating device performance. Of 2,988 eligible patients, microscopy showed that 547 (18%) had P. falciparum, 658 (22%) had P. vivax, 2 (0.07%) had P. malariae, and 1,750 (59%) were negative for Plasmodium. Mixed infections (P. falciparum and P. vivax) were identified in 31 patients (1%). The overall sensitivity of ParaSight F for P. falciparum was 95%. When stratified by magnitude of parasitemia (no. of asexual parasites per microliter of whole blood), sensitivities were 83% (>0 to 500 parasites/µl), 87% (501 to 1,000/µl), 98% (1,001 to 5,000/µl), and 98% (>5,000/µl). Device specificity was 86%.

* Corresponding author. Mailing address: MADN-CHEM, United States Military Academy, Official Mail & Distribution Center, 646 Swift Rd., West Point, NY 10996-1905. Phone: (845) 938-8298. Fax: (845) 938-2235. E-mail: mj9173{at}usma.edu.

Journal of Clinical Microbiology, August 2001, p. 2884-2890, Vol. 39, No. 8
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.8.2884-2890.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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