title: Diagnostic performance of rapid diagnostic tests for the diagnosis of malaria at public health facilities in north-west Ethiopia.
abstract: OBJECTIVE
  To assess the performance of RDTs against nested polymerase chain reaction (nPCR) for the diagnosis of malaria in public health facilities in north-western Ethiopia.
  
  
  METHODS
  Cross-sectional study at public health facilities in North Gondar, Ethiopia, of 359 febrile patients with signs and symptoms consistent with malaria. Finger prick blood samples were collected for testing in a P. falciparum/pan-malaria RDTs and for molecular analysis. Sensitivity, specificity and predictive values were determined for the RDTs using nPCR as reference diagnostic method. Kappa value was determined to demonstrate the consistency of the results between the diagnostic tools.
  
  
  RESULTS
  By RDTs, 22.28% (80/359) of patients tested positive for malaria, and by nPCR, 27.02% (97/359) did. In nPCR, 1.67% (6/359) and 0.28% (1/359) samples were positive for P. ovale and P. malariae, which had almost all tested negative in the RDTs. The sensitivity, specificity, positive and negative predictive values of RDTs for the diagnosis of malaria were 62.9%, 92.7%, 76.3% and 87.1%, respectively, with 0.589 measurement agreement between RDTs and nPCR. The sensitivity and specificity of RDTs for P. falciparum identification only were 70.8% and 95.2%, and 65.2% and 93.1% for P. vivax.
  
  
  CONCLUSIONS
  Although RDTs are commonly used at health posts in resource-limited environments, their sensitivity and specificity for the detection and species identification of Plasmodium parasites were poor compared to nPCR, suggesting caution in interpreting RDTs results. Particularly, in the light of expanded efforts to eliminate malaria in the country, more sensitive diagnostic procedures will be needed.
authors.affiliation: Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
authors.forename: Gebeyaw
authors.initials: G
authors.lastname: Getnet
authors.affiliation: Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
authors.forename: Sisay
authors.initials: S
authors.lastname: Getie
authors.affiliation: Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: Mitaly
authors.initials: M
authors.lastname: Srivastava
authors.affiliation: Department of Immunology and Molecular Biology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
authors.forename: Wubet
authors.initials: W
authors.lastname: Birhan
authors.affiliation: School of Medicine, College of Medicine and Health Sciences, Wolaita Sodo University, Wolaita, Ethiopia.|Walter and Eliza Hall Institute for Medical Research, Melbourne, Vic., Australia.
authors.forename: Abebe A
authors.initials: AA
authors.lastname: Fola
authors.affiliation: Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: Harald
authors.initials: H
authors.lastname: Noedl
keywords: Ethiopia; Ethiopie; Etiopía; PCR anidada; TDR; desempeño diagnóstico; diagnostic performance; nPCR; nested polymerase chain reaction; performance diagnostique; pruebas de diagnóstico rápido; rapid diagnostic tests