Field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in Cameroon

Malaria Journal

Research

Fidelis Cho-Ngwa¹  Etienne Fondjo²  Albert Same-Ekobo³  Vicky Ama Moor⁴  Rose G. F. Leke⁵  Vivian Tchinda⁶  Theresa Nkoa⁷  Dorothy A. Forsah⁸  Joseph Mbede⁹  Philomena Nyongalema^1,10  Jude D. Bigoga^1,10  Wilfred F. Mbacham^1,10  Josephine Fogako^1,10  Innocent M. Ali^1,11 

[1] Department of Biochemistry and Molecular Biology, University of Buea, Buea, Cameroon;Department of Biochemistry, University of Dschang, Dschang, Cameroon;Faculty of Health Sciences, Université des Montagnes, Bangante, Cameroon;Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon;Laboratory of Immunology and Parasitology, The Biotechnology Centre, University of Yaoundé 1, BP 8094, Yaoundé, Cameroon;Medical Research Centre, Institute of Medical Research and Medicinal Plant Study, Yaoundé, Cameroon;Ministry of Public Health, Yaoundé, Cameroon;National Malaria Control Program, Ministry of Public Health, Yaoundé, Cameroon;Paediatrics Unit, University Teaching Hospital, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1, Yaoundé, Cameroon;The Biotechnology Centre, University of Yaoundé 1, BP 8094, Yaoundé, Cameroon;The Biotechnology Centre, University of Yaoundé 1, BP 8094, Yaoundé, Cameroon;Department of Biochemistry, University of Dschang, Dschang, Cameroon;

关键词: Malaria;    Sensitivity;    Rapid diagnostic test;    Microscopy;    Specificity;    HRP2;    Positive predictive value;    Plasmodium falciparum;   

DOI  :  10.1186/s12936-016-1085-0

 received in 2015-06-07, accepted in 2016-01-08,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundAll 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.MethodsOne 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.ResultsOf 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.ConclusionOverall, 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.

【 授权许可】

CC BY   
© Ali et al. 2016