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Journal of Clinical Microbiology, December 2002, p. 4528-4530, Vol. 40, No. 12
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.12.4528-4530.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Evaluation of the Makromed Dipstick Assay versus PCR for Diagnosis of Plasmodium falciparum Malaria in Returned Travelers

David C. Richardson, Michele Ciach, Kathleen J. Y. Zhong, Ian Crandall, and Kevin C. Kain*

Tropical Disease Unit, Division of Infectious Diseases, Department of Medicine, University of Toronto, and Toronto General Hospital-University Health Network, Toronto, Canada

Received 10 July 2002/ Returned for modification 6 August 2002/ Accepted 4 September 2002

Microscopy has been the traditional reference standard for malaria diagnosis. However, difficulty in maintaining the required technical skills, particularly in areas where malaria is not endemic, has prompted the development of rapid nonmicroscopic diagnostic assays based on the detection of malaria parasite antigen in whole blood. In this study, we evaluated the performance of one such device, the Makromed dipstick test, blindly compared to PCR and microscopy for the diagnosis of Plasmodium falciparum malaria in 200 febrile returned travelers. The Makromed assay detects the presence of P. falciparum-specific histidine-rich protein II with an antigen capture immunochromatographic strip format. Compared to PCR as the reference standard, the dipstick assay had a sensitivity of 97.0% and a specificity of 96.0%. The positive and negative predictive values were 81.2% and 99.5%, respectively. Rapid malaria diagnostic devices may provide a useful diagnostic adjunct in a clinical setting.

* Corresponding author. Mailing address: Tropical Disease Unit, EN G-224, Toronto General Hospital, 200 Elizabeth St., Toronto, Canada M5G 2C4. Phone: (416) 340-3535. Fax: (416) 595-5826. E-mail: kevin.kain{at}uhn.on.ca.

Journal of Clinical Microbiology, December 2002, p. 4528-4530, Vol. 40, No. 12
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.12.4528-4530.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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