Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN)

 

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dc.contributor.author Lourens, Chris en_ZA
dc.contributor.author Watkins, William en_ZA
dc.contributor.author Barnes, Karen en_ZA
dc.contributor.author Sibley, Carol en_ZA
dc.contributor.author Guerin, Philippe en_ZA
dc.contributor.author White, Nicholas en_ZA
dc.contributor.author Lindegardh, Niklas en_ZA
dc.date.accessioned 2015-11-11T12:02:09Z
dc.date.available 2015-11-11T12:02:09Z
dc.date.issued 2010 en_ZA
dc.identifier.citation Lourens, C., Watkins, W. M., Barnes, K. I., Sibley, C. H., Guerin, P. J., White, N. J., & Lindegardh, N. (2010). Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN). Malar. J, 9(375), 10-1186. en_ZA
dc.identifier.uri http://hdl.handle.net/11427/14892
dc.identifier.uri http://dx.doi.org/10.1186/1475-2875-9-375
dc.description.abstract BACKGROUND: The Worldwide Antimalarial Resistance Network (WWARN) is a global collaboration to support the objective that anyone affected by malaria receives effective and safe drug treatment. The Pharmacology module aims to inform optimal anti-malarial drug selection. There is an urgent need to define the drug exposure - effect relationship for most anti-malarial drugs. Few anti-malarials have had their therapeutic blood concentration levels defined. One of the main challenges in assessing safety and efficacy data in relation to drug concentrations is the comparability of data generated from different laboratories. To explain differences in anti-malarial pharmacokinetics in studies with different measurement laboratories it is necessary to confirm the accuracy of the assay methods. This requires the establishment of an external quality assurance process to assure results that can be compared. This paper describes this process. METHODS: The pharmacology module of WWARN has established a quality assurance/quality control (QA/QC) programme consisting of two separate components:1. A proficiency testing programme where blank human plasma spiked with certified reference material (CRM) in different concentrations is sent out to participating bioanalytical laboratories.2. A certified reference standard programme where accurately weighed amounts of certified anti-malarial reference standards, metabolites, and internal standards are sent to participating bioanalytical and in vitro laboratories. CONCLUSION: The proficiency testing programme is designed as a cooperative effort to help participating laboratories assess their ability to carry out drug analysis, resolve any potential problem areas and to improve their results - and, in so doing, to improve the quality of anti-malarial pharmacokinetic data published and shared with WWARN.By utilizing the same source of standards for all laboratories, it is possible to minimize bias arising from poor quality reference standards. By providing anti-malarial drug standards from a central point, it is possible to lower the cost of these standards. en_ZA
dc.language.iso eng en_ZA
dc.publisher BioMed Central Ltd en_ZA
dc.rights This is an Open Access article distributed under the terms of the Creative Commons Attribution License en_ZA
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en_ZA
dc.source Malaria Journal en_ZA
dc.source.uri http://www.malariajournal.com/ en_ZA
dc.subject.other Antimalarials en_ZA
dc.subject.other Malaria en_ZA
dc.subject.other Reference Standards en_ZA
dc.title Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN) en_ZA
dc.type Journal Article en_ZA
dc.rights.holder 2010 Lourens et al; licensee BioMed Central Ltd. en_ZA
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Division of Clinical Pharmacology en_ZA
uct.type.filetype Text
uct.type.filetype Image
dc.identifier.apacitation Lourens, C., Watkins, W., Barnes, K., Sibley, C., Guerin, P., White, N., & Lindegardh, N. (2010). Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN). <i>Malaria Journal</i>, http://hdl.handle.net/11427/14892 en_ZA
dc.identifier.chicagocitation Lourens, Chris, William Watkins, Karen Barnes, Carol Sibley, Philippe Guerin, Nicholas White, and Niklas Lindegardh "Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN)." <i>Malaria Journal</i> (2010) http://hdl.handle.net/11427/14892 en_ZA
dc.identifier.vancouvercitation Lourens C, Watkins W, Barnes K, Sibley C, Guerin P, White N, et al. Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN). Malaria Journal. 2010; http://hdl.handle.net/11427/14892. en_ZA
dc.identifier.ris TY - Journal Article AU - Lourens, Chris AU - Watkins, William AU - Barnes, Karen AU - Sibley, Carol AU - Guerin, Philippe AU - White, Nicholas AU - Lindegardh, Niklas AB - BACKGROUND: The Worldwide Antimalarial Resistance Network (WWARN) is a global collaboration to support the objective that anyone affected by malaria receives effective and safe drug treatment. The Pharmacology module aims to inform optimal anti-malarial drug selection. There is an urgent need to define the drug exposure - effect relationship for most anti-malarial drugs. Few anti-malarials have had their therapeutic blood concentration levels defined. One of the main challenges in assessing safety and efficacy data in relation to drug concentrations is the comparability of data generated from different laboratories. To explain differences in anti-malarial pharmacokinetics in studies with different measurement laboratories it is necessary to confirm the accuracy of the assay methods. This requires the establishment of an external quality assurance process to assure results that can be compared. This paper describes this process. METHODS: The pharmacology module of WWARN has established a quality assurance/quality control (QA/QC) programme consisting of two separate components:1. A proficiency testing programme where blank human plasma spiked with certified reference material (CRM) in different concentrations is sent out to participating bioanalytical laboratories.2. A certified reference standard programme where accurately weighed amounts of certified anti-malarial reference standards, metabolites, and internal standards are sent to participating bioanalytical and in vitro laboratories. CONCLUSION: The proficiency testing programme is designed as a cooperative effort to help participating laboratories assess their ability to carry out drug analysis, resolve any potential problem areas and to improve their results - and, in so doing, to improve the quality of anti-malarial pharmacokinetic data published and shared with WWARN.By utilizing the same source of standards for all laboratories, it is possible to minimize bias arising from poor quality reference standards. By providing anti-malarial drug standards from a central point, it is possible to lower the cost of these standards. DA - 2010 DB - OpenUCT DO - 10.1186/1475-2875-9-375 DP - University of Cape Town J1 - Malaria Journal LK - https://open.uct.ac.za PB - University of Cape Town PY - 2010 T1 - Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN) TI - Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN) UR - http://hdl.handle.net/11427/14892 ER - en_ZA


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