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

Abstract

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.

PCR-based methods to the diagnosis of imported malaria

“…All the patients positive by microscopy were also positive by PCR, whatever the Plasmodium species. When compared to the set of the requests, the gain of sensitivity was 4.4 % (range: from 0 to + 11 %) (Rubio et al, 1999;Filisetti et al, 2002;Morassin et al, 2002;Richardson et al, 2002;de Monbrison et al, 2003;Padley et al, 2003;Patsoula et al, 2003;Perandin et al, 2003;Calderaro et al, 2004;Fabre et al, 2004;Perandin et al, 2004;Rougemont et al, 2004;Whiley et al, 2004;Machouart et al, 2006;Vo et al, 2007). This improvement in sensitivity affected mainly falciparum malaria.…”

Malaria

“…Der Antikörper kreuzreagiert mit Plasmodium vivax, allerdings mit geringerer Sensitivität. Bei Verwenden von Antikör-pern gegen das histidine-rich-protein II von Plasmodium falciparum wurde eine Sensitivität von 97 % und Spezifität von 96 % bei Reiserückkehrern erreicht [29].…”

Malaria

“…The antibody cross-reacts with P. vivax, but at a low sensitivity. When antibodies were used against histidine-rich protein II of P. falciparum, a sensitivity of 97% and a specificity of 96% were obtained in travel returnees [29]. Depending on the exposure, a sensitivity of 88% and a specificity of 99% can be reached for P. falciparum.…”