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

Author:

Farcas Gabriella A.1,Zhong Kathleen J. Y.2,Mazzulli Tony34,Kain Kevin C.1524

Affiliation:

1. Institute of Medical Science, Department of Medicine

2. Tropical Disease Unit, Division of Infectious Diseases, Toronto General Hospital-University Health Network

3. Department of Laboratory Medicine and Pathobiology

4. Department of Microbiology, Toronto Medical Labs/Mount Sinai Hospital, Toronto, Ontario, Canada

5. Global Health Program, McLaughlin Center for Molecular Medicine, University of Toronto

Abstract

ABSTRACT 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.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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