Molecular malaria diagnostics: A systematic review and meta-analysis

Abstract

Accurate diagnosis of malaria is essential for identification and subsequent treatment of the disease. Currently, microscopy and rapid diagnostic tests are the most commonly used diagnostics, next to treatment based on clinical signs only. These tests are easy to deploy, but have a relatively high detection limit. With declining prevalence in many areas, there is an increasing need for more sensitive diagnostics. Molecular tools may be a suitable alternative, although costs and technical requirements currently hamper their implementation in resource limited settings. A range of (near) point-of-care diagnostics is therefore under development, including simplifications in sample preparation, amplification and/or read-out of the test. Accuracy data, in combination with technical characteristics, are essential in determining which molecular test, if any, would be the most promising to be deployed. This review presents a comprehensive overview of the currently available molecular malaria diagnostics, ranging from well-known tests to platforms in early stages of evaluation, and systematically evaluates their published accuracy. No important difference in accuracy was found between the most commonly used PCR-based assays (conventional, nested and real-time PCR), with most of them having high sensitivity and specificity, implying that there are no reasons other than practical ones to choose one technique over the other. Loop-mediated isothermal amplification and other (novel) diagnostics appear to be highly accurate as well, with some offering potential to be used in resource-limited settings.

• Diagnostic test accuracy
• loop-mediated isothermal amplification
• microscopy
• molecular diagnostic
• Plasmodium
• point-of-care
• polymerase chain reaction
• rapid diagnostic test

Acknowledgements

We would like to thank all authors who kindly provided additional data not published in the original papers.

Declaration of interest

This study was supported by EU FP7-Health-2013.0-1. Project no.: 601714. Translation of the direct-on-blood PCR-NALFIA system into an innovative near point-of-care diagnostic for malaria (DIAGMAL). J.R. is working on the development of the direct-on-blood PCR-NALFIA system. The authors alone are responsible for the content and writing of this article.

Supplementary material (Additional files 1 and 2) available online

Notes

* Referees: Dr. Georges Snounou, Universite Pierre et Marie Curie, CIMI-Paris, France; Dr. Paul LaBarre, PATH, Seattle, USA; Dr. Elizabeth Pienaar, South African Cochrane Center, Tygerberg, South Africa