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

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 ca...

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Autores principales: Ali, Innocent M., Bigoga, Jude D., Forsah, Dorothy A., Cho-Ngwa, Fidelis, Tchinda, Vivian, Moor, Vicky Ama, Fogako, Josephine, Nyongalema, Philomena, Nkoa, Theresa, Same-Ekobo, Albert, Mbede, Joseph, Fondjo, Etienne, Mbacham, Wilfred F., Leke, Rose G. F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4721050/
https://www.ncbi.nlm.nih.gov/pubmed/26791422
http://dx.doi.org/10.1186/s12936-016-1085-0
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author Ali, Innocent M.
Bigoga, Jude D.
Forsah, Dorothy A.
Cho-Ngwa, Fidelis
Tchinda, Vivian
Moor, Vicky Ama
Fogako, Josephine
Nyongalema, Philomena
Nkoa, Theresa
Same-Ekobo, Albert
Mbede, Joseph
Fondjo, Etienne
Mbacham, Wilfred F.
Leke, Rose G. F.
author_facet Ali, Innocent M.
Bigoga, Jude D.
Forsah, Dorothy A.
Cho-Ngwa, Fidelis
Tchinda, Vivian
Moor, Vicky Ama
Fogako, Josephine
Nyongalema, Philomena
Nkoa, Theresa
Same-Ekobo, Albert
Mbede, Joseph
Fondjo, Etienne
Mbacham, Wilfred F.
Leke, Rose G. F.
author_sort Ali, Innocent M.
collection PubMed
description 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. CONCLUSION: 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12936-016-1085-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-47210502016-01-22 Field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in Cameroon Ali, Innocent M. Bigoga, Jude D. Forsah, Dorothy A. Cho-Ngwa, Fidelis Tchinda, Vivian Moor, Vicky Ama Fogako, Josephine Nyongalema, Philomena Nkoa, Theresa Same-Ekobo, Albert Mbede, Joseph Fondjo, Etienne Mbacham, Wilfred F. Leke, Rose G. F. Malar J Research 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. CONCLUSION: 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12936-016-1085-0) contains supplementary material, which is available to authorized users. BioMed Central 2016-01-20 /pmc/articles/PMC4721050/ /pubmed/26791422 http://dx.doi.org/10.1186/s12936-016-1085-0 Text en © Ali et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Ali, Innocent M.
Bigoga, Jude D.
Forsah, Dorothy A.
Cho-Ngwa, Fidelis
Tchinda, Vivian
Moor, Vicky Ama
Fogako, Josephine
Nyongalema, Philomena
Nkoa, Theresa
Same-Ekobo, Albert
Mbede, Joseph
Fondjo, Etienne
Mbacham, Wilfred F.
Leke, Rose G. F.
Field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in Cameroon
title Field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in Cameroon
title_full Field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in Cameroon
title_fullStr Field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in Cameroon
title_full_unstemmed Field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in Cameroon
title_short Field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in Cameroon
title_sort field evaluation of the 22 rapid diagnostic tests for community management of malaria with artemisinin combination therapy in cameroon
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4721050/
https://www.ncbi.nlm.nih.gov/pubmed/26791422
http://dx.doi.org/10.1186/s12936-016-1085-0
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