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Journal of Clinical Microbiology, February 2004, p. 636-638, Vol. 42, No. 2
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.2.636-638.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Evaluation of the RealArt Malaria LC Real-Time PCR Assay for Malaria Diagnosis

Gabriella A. Farcas,1 Kathleen J. Y. Zhong,2 Tony Mazzulli,3,4 and Kevin C. Kain1,2,3,5*

Institute of Medical Science, Department of Medicine,1 Department of Laboratory Medicine and Pathobiology,4 Global Health Program, McLaughlin Center for Molecular Medicine, University of Toronto,5 Tropical Disease Unit, Division of Infectious Diseases, Toronto General Hospital-University Health Network,2 Department of Microbiology, Toronto Medical Labs/Mount Sinai Hospital, Toronto, Ontario, Canada3

Received 21 August 2003/ Returned for modification 19 September 2003/ Accepted 29 October 2003

PCR-based methods have advantages over traditional microscopic methods for the diagnosis of malaria, especially in cases of low parasitemia and mixed infections. However, current PCR-based assays are often labor-intensive and not readily quantifiable and have the potential for contamination due to a requirement for postamplification sample handling. Real-time PCR can address these limitations. This study evaluated the performance characteristics of a commercial malaria real-time PCR assay (RealArt Malaria LC Assay; Artus GmbH, Hamburg, Germany) on the LightCycler platform for the detection of malaria parasites in 259 febrile returned travelers. Compared to nested PCR as the reference standard, the real-time assay had a sensitivity of 99.5%, specificity of 100%, positive predictive value of 100%, and negative predictive value of 99.6% for the detection of malaria. Our results indicate that the RealArt assay is a rapid (<45 min), sensitive, and specific method for the detection of malaria in returned travelers.

* Corresponding author. Mailing address: Tropical Disease Unit, Eaton South 9-414, Toronto General Hospital, 200 Elizabeth St., Toronto, Ontario, Canada M5G 2C4. Phone: (416) 340-3535. Fax: (416) 595-5826. E-mail: Kevin.kain{at}uhn.on.ca.

Journal of Clinical Microbiology, February 2004, p. 636-638, Vol. 42, No. 2
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.2.636-638.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



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