Molecular assays for antimalarial drug resistance surveillance: A target product profile

Christian Nsanzabana; Frederic Ariey; Hans Peter Beck; Xavier C. Ding; Edwin Kamau; Sanjeev Krishna; Eric Legrand; Naomi Lucchi; Olivo Miotto; Sidsel Nag; Harald Noedl; Cally Roper; Philip J. Rosenthal; Henk D.F.H. Schallig; Steve M. Taylor; Sarah K. Volkman; Iveth J. Gonzalez

doi:10.1371/journal.pone.0204347

Molecular assays for antimalarial drug resistance surveillance: A target product profile

Christian Nsanzabana^*, Frederic Ariey, Hans Peter Beck, Xavier C. Ding, Edwin Kamau, Sanjeev Krishna, Eric Legrand, Naomi Lucchi, Olivo Miotto, Sidsel Nag, Harald Noedl, Cally Roper, Philip J. Rosenthal, Henk D.F.H. Schallig, Steve M. Taylor, Sarah K. Volkman, Iveth J. Gonzalez

^*Corresponding author for this work

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Abstract

Antimalarial drug resistance is a major constraint for malaria control and elimination efforts. Artemisinin-based combination therapy is now the mainstay for malaria treatment. However, delayed parasite clearance following treatment with artemisinin derivatives has now spread in the Greater Mekong Sub region and may emerge or spread to other malaria endemic regions. This spread is of great concern for malaria control programmes, as no alternatives to artemisinin-based combination therapies are expected to be available in the near future. There is a need to strengthen surveillance systems for early detection and response to the antimalarial drug resistance threat. Current surveillance is mainly done through therapeutic efficacy studies; however these studies are complex and both time- and resource-intensive. For multiple common antimalarials, parasite drug resistance has been correlated with specific genetic mutations, and the molecular markers associated with antimalarial drug resistance offer a simple and powerful tool to monitor the emergence and spread of resistant parasites. Different techniques to analyse molecular markers associated with antimalarial drug resistance are available, each with advantages and disadvantages. However, procedures are not adequately harmonized to facilitate comparisons between sites. Here we describe the target product profiles for tests to analyse molecular markers associated with antimalarial drug resistance, discuss how use of current techniques can be standardised, and identify the requirements for an ideal product that would allow malaria endemic countries to provide useful spatial and temporal information on the spread of resistance.

Original language	English
Article number	e0204347
Journal	PLOS ONE
Volume	13
Issue number	9
Number of pages	18
ISSN	1932-6203
DOIs	https://doi.org/10.1371/journal.pone.0204347
Publication status	Published - 2018

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Nsanzabana, C., Ariey, F., Beck, H. P., Ding, X. C., Kamau, E., Krishna, S., Legrand, E., Lucchi, N., Miotto, O., Nag, S., Noedl, H., Roper, C., Rosenthal, P. J., Schallig, H. D. F. H., Taylor, S. M., Volkman, S. K., & Gonzalez, I. J. (2018). Molecular assays for antimalarial drug resistance surveillance: A target product profile. PLOS ONE, 13(9), Article e0204347. https://doi.org/10.1371/journal.pone.0204347

Nsanzabana, C, Ariey, F, Beck, HP, Ding, XC, Kamau, E, Krishna, S, Legrand, E, Lucchi, N, Miotto, O, Nag, S, Noedl, H, Roper, C, Rosenthal, PJ, Schallig, HDFH, Taylor, SM, Volkman, SK & Gonzalez, IJ 2018, 'Molecular assays for antimalarial drug resistance surveillance: A target product profile', PLOS ONE, vol. 13, no. 9, e0204347. https://doi.org/10.1371/journal.pone.0204347

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title = "Molecular assays for antimalarial drug resistance surveillance: A target product profile",

abstract = "Antimalarial drug resistance is a major constraint for malaria control and elimination efforts. Artemisinin-based combination therapy is now the mainstay for malaria treatment. However, delayed parasite clearance following treatment with artemisinin derivatives has now spread in the Greater Mekong Sub region and may emerge or spread to other malaria endemic regions. This spread is of great concern for malaria control programmes, as no alternatives to artemisinin-based combination therapies are expected to be available in the near future. There is a need to strengthen surveillance systems for early detection and response to the antimalarial drug resistance threat. Current surveillance is mainly done through therapeutic efficacy studies; however these studies are complex and both time- and resource-intensive. For multiple common antimalarials, parasite drug resistance has been correlated with specific genetic mutations, and the molecular markers associated with antimalarial drug resistance offer a simple and powerful tool to monitor the emergence and spread of resistant parasites. Different techniques to analyse molecular markers associated with antimalarial drug resistance are available, each with advantages and disadvantages. However, procedures are not adequately harmonized to facilitate comparisons between sites. Here we describe the target product profiles for tests to analyse molecular markers associated with antimalarial drug resistance, discuss how use of current techniques can be standardised, and identify the requirements for an ideal product that would allow malaria endemic countries to provide useful spatial and temporal information on the spread of resistance.",

author = "Christian Nsanzabana and Frederic Ariey and Beck, {Hans Peter} and Ding, {Xavier C.} and Edwin Kamau and Sanjeev Krishna and Eric Legrand and Naomi Lucchi and Olivo Miotto and Sidsel Nag and Harald Noedl and Cally Roper and Rosenthal, {Philip J.} and Schallig, {Henk D.F.H.} and Taylor, {Steve M.} and Volkman, {Sarah K.} and Gonzalez, {Iveth J.}",

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AU - Nsanzabana, Christian

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AU - Kamau, Edwin

AU - Krishna, Sanjeev

AU - Legrand, Eric

AU - Lucchi, Naomi

AU - Miotto, Olivo

AU - Nag, Sidsel

AU - Noedl, Harald

AU - Roper, Cally

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AU - Volkman, Sarah K.

AU - Gonzalez, Iveth J.

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N2 - Antimalarial drug resistance is a major constraint for malaria control and elimination efforts. Artemisinin-based combination therapy is now the mainstay for malaria treatment. However, delayed parasite clearance following treatment with artemisinin derivatives has now spread in the Greater Mekong Sub region and may emerge or spread to other malaria endemic regions. This spread is of great concern for malaria control programmes, as no alternatives to artemisinin-based combination therapies are expected to be available in the near future. There is a need to strengthen surveillance systems for early detection and response to the antimalarial drug resistance threat. Current surveillance is mainly done through therapeutic efficacy studies; however these studies are complex and both time- and resource-intensive. For multiple common antimalarials, parasite drug resistance has been correlated with specific genetic mutations, and the molecular markers associated with antimalarial drug resistance offer a simple and powerful tool to monitor the emergence and spread of resistant parasites. Different techniques to analyse molecular markers associated with antimalarial drug resistance are available, each with advantages and disadvantages. However, procedures are not adequately harmonized to facilitate comparisons between sites. Here we describe the target product profiles for tests to analyse molecular markers associated with antimalarial drug resistance, discuss how use of current techniques can be standardised, and identify the requirements for an ideal product that would allow malaria endemic countries to provide useful spatial and temporal information on the spread of resistance.

AB - Antimalarial drug resistance is a major constraint for malaria control and elimination efforts. Artemisinin-based combination therapy is now the mainstay for malaria treatment. However, delayed parasite clearance following treatment with artemisinin derivatives has now spread in the Greater Mekong Sub region and may emerge or spread to other malaria endemic regions. This spread is of great concern for malaria control programmes, as no alternatives to artemisinin-based combination therapies are expected to be available in the near future. There is a need to strengthen surveillance systems for early detection and response to the antimalarial drug resistance threat. Current surveillance is mainly done through therapeutic efficacy studies; however these studies are complex and both time- and resource-intensive. For multiple common antimalarials, parasite drug resistance has been correlated with specific genetic mutations, and the molecular markers associated with antimalarial drug resistance offer a simple and powerful tool to monitor the emergence and spread of resistant parasites. Different techniques to analyse molecular markers associated with antimalarial drug resistance are available, each with advantages and disadvantages. However, procedures are not adequately harmonized to facilitate comparisons between sites. Here we describe the target product profiles for tests to analyse molecular markers associated with antimalarial drug resistance, discuss how use of current techniques can be standardised, and identify the requirements for an ideal product that would allow malaria endemic countries to provide useful spatial and temporal information on the spread of resistance.

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Molecular assays for antimalarial drug resistance surveillance: A target product profile

Abstract

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