The authors declare that they have no competing interests.
PG and JJ designed the study protocol. MVE, JJ and EB organized prospective sample collection. MH and PG carried out the RDT test evaluations, LC performed PCR analysis. MH, PG, JM and JJ analysed and interpreted the results. MH, PG, JM and JJ drafted the manuscript. All authors critically reviewed the manuscript and approved the final manuscript.
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.
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).
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.
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.
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- Evaluation of the malaria rapid diagnostic test SDFK90: detection of both PfHRP2 and Pf-pLDH
Marjan Van Esbroeck
- BioMed Central
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