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Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Saharan Africa (DIAGMAL). / Kiemde, Francois; Tinto, Halidou; Carter, Jane et al.

In: PLoS ONE, Vol. 17, No. 9 September, e0272847, 09.2022, p. e0272847.

Research output: Contribution to journal › Article › Academic › peer-review

Harvard

Kiemde, F, Tinto, H, Carter, J, Rouamba, T, Valia, D, Conteh, L, Sicuri, E, Simmons, B, Nour, B, Mumbengegwi, D, Hailu, A, Munene, S, Talha, A, Aemero, M, Meakin, P, Paulussen, R, Page, S, Dijk, NV, Mens, P & Schallig, H 2022, 'Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Saharan Africa (DIAGMAL)', PLoS ONE, vol. 17, no. 9 September, e0272847, pp. e0272847. https://doi.org/10.1371/journal.pone.0272847

APA

Kiemde, F., Tinto, H., Carter, J., Rouamba, T., Valia, D., Conteh, L., Sicuri, E., Simmons, B., Nour, B., Mumbengegwi, D., Hailu, A., Munene, S., Talha, A., Aemero, M., Meakin, P., Paulussen, R., Page, S., Dijk, N. V., Mens, P., & Schallig, H. (2022). Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Saharan Africa (DIAGMAL). PLoS ONE, 17(9 September), e0272847. [e0272847]. https://doi.org/10.1371/journal.pone.0272847

Vancouver

Kiemde F, Tinto H, Carter J, Rouamba T, Valia D, Conteh L et al. Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Saharan Africa (DIAGMAL). PLoS ONE. 2022 Sep;17(9 September):e0272847. e0272847. doi: 10.1371/journal.pone.0272847

Author

Kiemde, Francois ; Tinto, Halidou ; Carter, Jane et al. / Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Saharan Africa (DIAGMAL). In: PLoS ONE. 2022 ; Vol. 17, No. 9 September. pp. e0272847.

BibTeX

@article{ce410917f8da46a892d5f794b2b0d803,
title = "Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Saharan Africa (DIAGMAL)",
abstract = "Background Rapid Diagnostic Tests (RDTs) have become the cornerstone for the management of malaria in many endemic settings, but their use is constrained for several reasons: (i) persistent malaria antigen (histidine-rich protein 2; HRP2) leading to false positive test results; (ii) hrp2 deletions leading to false negative PfHRP2 results; and (iii) limited sensitivity with a detection threshold of around 100 parasites/μl blood (pLDH- and HRP2-based) leading to false negative tests. Microscopy is still the gold standard for malaria diagnosis, and allows for species determination and quantitation, but requires trained microscopists, maintained microscopes and has detection limit issues. Consequently, there is a pressing need to develop and evaluate more sensitive and accurate diagnostic tests. To address this need we have developed a direct on blood mini PCR-NALFIA test that combines the benefits of molecular biology with low infrastructural requirements and extensive training. Methods This is a Phase 3 diagnostic evaluation in 5 African countries. Study sites (Sudan, Ethiopia, Burkina, Kenya and Namibia) were selected to ensure wide geographical coverage of Africa and to address various malaria epidemiological contexts ranging from high transmission to near elimination settings with different clinical scenarios and diagnostic challenges. Study participants will be enrolled at the study health facilities after obtaining written informed consent. Diagnostic accuracy will be assessed following the WHO/TDR guidelines for the evaluation of diagnostics and reported according to STARD principles. Due to the lack of a 100% specific and sensitive standard diagnostic test for malaria, the sensitivity and specificity of the new test will be compared to the available diagnostic practices in place at the selected sites and to quantitative PCR as the reference test. Discussion This phase 3 study is designed to validate the clinical performance and feasibility of implementing a new diagnostic tool for the detection of malaria in real clinical settings. If successful, the proposed technology will improve the diagnosis of malaria. Enrolment started in November 2022 (Kenya) with assessment of long term outcome to be completed by 2023 at all recruitment sites.",
author = "Francois Kiemde and Halidou Tinto and Jane Carter and Toussaint Rouamba and Daniel Valia and Lesong Conteh and Elisa Sicuri and Bryony Simmons and Bakri Nour and Davis Mumbengegwi and Asrat Hailu and Stephen Munene and Albadawi Talha and Mulugeta Aemero and Paul Meakin and Ren{\'e} Paulussen and Scott Page and Dijk, {Norbert van} and Petra Mens and Henk Schallig",
note = "Funding Information: European & Developing Countries Clinical Trials Partnership as part of the EDCTP2 programme supported by the European Union (grant number RIA2018D-2496-DIAGMAL - HDFHS coordinator). FK is a recipient of a Career Developing Fellowship (CDF) from EDCTP (TMA2019CDF-2697). The funder had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. Publisher Copyright: Copyright: {\textcopyright} 2022 Kiemde et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.",
year = "2022",
month = sep,
doi = "10.1371/journal.pone.0272847",
language = "English",
volume = "17",
pages = "e0272847",
journal = "PLoS ONE",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "9 September",

}

RIS

TY - JOUR

T1 - Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Saharan Africa (DIAGMAL)

AU - Kiemde, Francois

AU - Tinto, Halidou

AU - Carter, Jane

AU - Rouamba, Toussaint

AU - Valia, Daniel

AU - Conteh, Lesong

AU - Sicuri, Elisa

AU - Simmons, Bryony

AU - Nour, Bakri

AU - Mumbengegwi, Davis

AU - Hailu, Asrat

AU - Munene, Stephen

AU - Talha, Albadawi

AU - Aemero, Mulugeta

AU - Meakin, Paul

AU - Paulussen, René

AU - Page, Scott

AU - Dijk, Norbert van

AU - Mens, Petra

AU - Schallig, Henk

N1 - Funding Information: European & Developing Countries Clinical Trials Partnership as part of the EDCTP2 programme supported by the European Union (grant number RIA2018D-2496-DIAGMAL - HDFHS coordinator). FK is a recipient of a Career Developing Fellowship (CDF) from EDCTP (TMA2019CDF-2697). The funder had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. Publisher Copyright: Copyright: © 2022 Kiemde et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

PY - 2022/9

Y1 - 2022/9

N2 - Background Rapid Diagnostic Tests (RDTs) have become the cornerstone for the management of malaria in many endemic settings, but their use is constrained for several reasons: (i) persistent malaria antigen (histidine-rich protein 2; HRP2) leading to false positive test results; (ii) hrp2 deletions leading to false negative PfHRP2 results; and (iii) limited sensitivity with a detection threshold of around 100 parasites/μl blood (pLDH- and HRP2-based) leading to false negative tests. Microscopy is still the gold standard for malaria diagnosis, and allows for species determination and quantitation, but requires trained microscopists, maintained microscopes and has detection limit issues. Consequently, there is a pressing need to develop and evaluate more sensitive and accurate diagnostic tests. To address this need we have developed a direct on blood mini PCR-NALFIA test that combines the benefits of molecular biology with low infrastructural requirements and extensive training. Methods This is a Phase 3 diagnostic evaluation in 5 African countries. Study sites (Sudan, Ethiopia, Burkina, Kenya and Namibia) were selected to ensure wide geographical coverage of Africa and to address various malaria epidemiological contexts ranging from high transmission to near elimination settings with different clinical scenarios and diagnostic challenges. Study participants will be enrolled at the study health facilities after obtaining written informed consent. Diagnostic accuracy will be assessed following the WHO/TDR guidelines for the evaluation of diagnostics and reported according to STARD principles. Due to the lack of a 100% specific and sensitive standard diagnostic test for malaria, the sensitivity and specificity of the new test will be compared to the available diagnostic practices in place at the selected sites and to quantitative PCR as the reference test. Discussion This phase 3 study is designed to validate the clinical performance and feasibility of implementing a new diagnostic tool for the detection of malaria in real clinical settings. If successful, the proposed technology will improve the diagnosis of malaria. Enrolment started in November 2022 (Kenya) with assessment of long term outcome to be completed by 2023 at all recruitment sites.

AB - Background Rapid Diagnostic Tests (RDTs) have become the cornerstone for the management of malaria in many endemic settings, but their use is constrained for several reasons: (i) persistent malaria antigen (histidine-rich protein 2; HRP2) leading to false positive test results; (ii) hrp2 deletions leading to false negative PfHRP2 results; and (iii) limited sensitivity with a detection threshold of around 100 parasites/μl blood (pLDH- and HRP2-based) leading to false negative tests. Microscopy is still the gold standard for malaria diagnosis, and allows for species determination and quantitation, but requires trained microscopists, maintained microscopes and has detection limit issues. Consequently, there is a pressing need to develop and evaluate more sensitive and accurate diagnostic tests. To address this need we have developed a direct on blood mini PCR-NALFIA test that combines the benefits of molecular biology with low infrastructural requirements and extensive training. Methods This is a Phase 3 diagnostic evaluation in 5 African countries. Study sites (Sudan, Ethiopia, Burkina, Kenya and Namibia) were selected to ensure wide geographical coverage of Africa and to address various malaria epidemiological contexts ranging from high transmission to near elimination settings with different clinical scenarios and diagnostic challenges. Study participants will be enrolled at the study health facilities after obtaining written informed consent. Diagnostic accuracy will be assessed following the WHO/TDR guidelines for the evaluation of diagnostics and reported according to STARD principles. Due to the lack of a 100% specific and sensitive standard diagnostic test for malaria, the sensitivity and specificity of the new test will be compared to the available diagnostic practices in place at the selected sites and to quantitative PCR as the reference test. Discussion This phase 3 study is designed to validate the clinical performance and feasibility of implementing a new diagnostic tool for the detection of malaria in real clinical settings. If successful, the proposed technology will improve the diagnosis of malaria. Enrolment started in November 2022 (Kenya) with assessment of long term outcome to be completed by 2023 at all recruitment sites.

UR - http://www.scopus.com/inward/record.url?scp=85137138184&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0272847

DO - 10.1371/journal.pone.0272847

M3 - Article

C2 - 36048775

VL - 17

SP - e0272847

JO - PLoS ONE

JF - PLoS ONE

SN - 1932-6203

IS - 9 September

M1 - e0272847

ER -

ID: 25928732