title: Field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in Cameroon.
abstract: BACKGROUND
  All suspected cases of malaria should receive a diagnostic test prior to treatment with artemisinin-based combinations based on the new WHO malaria treatment guidelines. This study compared the accuracy and some operational characteristics of 22 different immunochromatographic antigen capture point-of- malaria tests (RDTs) in Cameroon to inform test procurement prior to deployment of artemisinin-based combinations for malaria treatment.
  
  
  METHODS
  One hundred human blood samples (50 positive and 50 negative) collected from consenting febrile patients in two health centres at Yaoundé were used for evaluation of the 22 RDTs categorized as "Pf Only" (9) or "Pf + PAN" (13) based on parasite antigen captured [histidine rich protein II (HRP2) or lactate dehydrogenase (pLDH) or aldolase]. RDTs were coded to blind technicians performing the tests. The sensitivity, specificity, and predictive values of the positive and negative tests (PPV and NPV) as well as the likelihood ratios were assessed. The reliability and some operational characteristics were determined as the mean values from two assessors, and the Cohen's kappa statistic was then used to compare agreement. Light microscopy was the referent.
  
  
  RESULTS
  Of all RDTs tested, 94.2 % (21/22) had sensitivity values greater than 90% among which 14 (63.6%) were 'Pf + PAN' RDTs. The specificity was generally lower than the sensitivity for all RDTs and poorer for "Pf Only" RDTs. The predictive values and likelihood ratios were better for non-HRP2 analytes for "Pf + PAN" RDTs. The Kappa value for most of the tests obtained was around 67% (95% CI 50-69%), corresponding to a moderate agreement.
  
  
  CONCLUSIONS
  Overall, 94.2% (21/22) of RDTs tested had accuracy within the range recommended by the WHO, while one performed poorly, below acceptable levels. Seven "Pf + PAN" and 3 "Pf Only" RDTs were selected for further assessment based on performance characteristics. Harmonizing RDT test presentation and procedures would prevent mistakes of test performance and interpretation.
authors.affiliation: The Biotechnology Centre, University of Yaoundé 1, BP 8094, Yaoundé, Cameroon. dr.alinn@gmail.com.|Department of Biochemistry, University of Dschang, Dschang, Cameroon. dr.alinn@gmail.com.
authors.forename: Innocent M
authors.initials: IM
authors.lastname: Ali
authors.affiliation: The Biotechnology Centre, University of Yaoundé 1, BP 8094, Yaoundé, Cameroon. jbigoga@gmail.com.
authors.forename: Jude D
authors.initials: JD
authors.lastname: Bigoga
authors.affiliation: National Malaria Control Program, Ministry of Public Health, Yaoundé, Cameroon. dollykah@yahoo.com.
authors.forename: Dorothy A
authors.initials: DA
authors.lastname: Forsah
authors.affiliation: Department of Biochemistry and Molecular Biology, University of Buea, Buea, Cameroon. chongwa_ub@yahoo.co.uk.
authors.forename: Fidelis
authors.initials: F
authors.lastname: Cho-Ngwa
authors.affiliation: Medical Research Centre, Institute of Medical Research and Medicinal Plant Study, Yaoundé, Cameroon. vtchinda1@yahoo.com.
authors.forename: Vivian
authors.initials: V
authors.lastname: Tchinda
authors.affiliation: Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon. movicky@yahoo.fr.
authors.forename: Vicky Ama
authors.initials: VA
authors.lastname: Moor
authors.affiliation: The Biotechnology Centre, University of Yaoundé 1, BP 8094, Yaoundé, Cameroon. fogakoj@yahoo.com.
authors.forename: Josephine
authors.initials: J
authors.lastname: Fogako
authors.affiliation: The Biotechnology Centre, University of Yaoundé 1, BP 8094, Yaoundé, Cameroon. gwanp2003@yahoo.com.
authors.forename: Philomena
authors.initials: P
authors.lastname: Nyongalema
authors.affiliation: Ministry of Public Health, Yaoundé, Cameroon. nkoath2002@yahoo.fr.
authors.forename: Theresa
authors.initials: T
authors.lastname: Nkoa
authors.affiliation: Faculty of Health Sciences, Université des Montagnes, Bangante, Cameroon. nouveausame@yahoo.fr.
authors.forename: Albert
authors.initials: A
authors.lastname: Same-Ekobo
authors.affiliation: Paediatrics Unit, University Teaching Hospital, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon. brjmbede@yahoo.fr.
authors.forename: Joseph
authors.initials: J
authors.lastname: Mbede
authors.affiliation: Department of Biochemistry, University of Dschang, Dschang, Cameroon. fondjoetienne@yahoo.fr.
authors.forename: Etienne
authors.initials: E
authors.lastname: Fondjo
authors.affiliation: The Biotechnology Centre, University of Yaoundé 1, BP 8094, Yaoundé, Cameroon. wfmbacham@yahoo.com.
authors.forename: Wilfred F
authors.initials: WF
authors.lastname: Mbacham
authors.affiliation: Laboratory of Immunology and Parasitology, The Biotechnology Centre, University of Yaoundé 1, BP 8094, Yaoundé, Cameroon. roseleke@yahoo.com.
authors.forename: Rose G F
authors.initials: RG
authors.lastname: Leke
mesh_terms: D000293:Adolescent; D000953:Antigens, Protozoan / Q000032:analysis; D000962:Antimalarials / Q000627:therapeutic use*; D037621:Artemisinins / Q000627:therapeutic use*; D002163:Cameroon; D002648:Child; D002675:Child, Preschool; D003955:Diagnostic Tests, Routine / Q000379:methods; D005260:Female; D006801:Humans; D007223:Infant; D008288:Malaria / Q000175:diagnosis* / Q000188:drug therapy* / Q000378:metabolism; D008297:Male; D015800:Protozoan Proteins / Q000032:analysis; D015203:Reproducibility of Results
chemical_list: D000953:Antigens, Protozoan; D000962:Antimalarials; D037621:Artemisinins; D015800:Protozoan Proteins