Open Access Highly Accessed Research

Evaluation of the malaria rapid diagnostic test SDFK90: detection of both PfHRP2 and Pf-pLDH

Marloes Heutmekers, Philippe Gillet, Lieselotte Cnops, Emmanuel Bottieau, Marjan Van Esbroeck, Jessica Maltha* and Jan Jacobs

Author Affiliations

Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium

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Malaria Journal 2012, 11:359  doi:10.1186/1475-2875-11-359

Published: 29 October 2012

Abstract

Background

Rapid diagnosis of Plasmodium falciparum infections is important because of the potentially fatal complications. SDFK90 is a recently marketed malaria rapid diagnostic test (RDT) targeting both histidine-rich protein 2 (PfHRP2) and P. falciparum-specific Plasmodium lactate dehydrogenase (Pf-pLDH). The present study evaluated its diagnostic accuracy.

Methods

SDFK90 was tested against a panel of stored whole blood samples (n= 591) obtained from international travellers suspected of malaria, including the four human Plasmodium species and Plasmodium negative samples. Microscopy was used as a reference method, corrected by PCR for species diagnosis. In addition, SDFK90 was challenged against 59 P. falciparum samples with parasite density ≥4% to assess the prozone effect (no or weak visible line on initial testing and a higher intensity upon 10-fold dilution).

Results

Overall sensitivity for the detection of P. falciparum was 98.5% and reached 99.3% at parasite densities >100/μl. There were significantly more PfHRP2 lines visible compared to Pf-pLDH (97.3% vs 86.9%), which was mainly absent at parasite densities <100/μl. Specificity of SDFK90 was 98.8%. No lot-to-lot variability was observed (p = 1.00) and test results were reproducible. A prozone effect was seen for the PfHRP2 line in 14/59 (23.7%) P. falciparum samples tested, but not for the Pf-pLDH line. Few minor shortcomings were observed in the kit’s packaging and information insert.

Conclusions

SDFK90 performed excellent for P. falciparum diagnosis. The combination of PfHRP2 and Pf-pLDH ensures a low detection threshold and counters potential problems of PfHRP2 detection such as gene deletions and the prozone effect.

Keywords:
Malaria; Plasmodium falciparum; Diagnosis; Rapid diagnostic test; Histidine-rich protein; Plasmodium falciparum-specific Plasmodium lactate dehydrogenase; Evaluation