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

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dc.contributor.authorLourens, Chrisen_ZA
dc.contributor.authorWatkins, Williamen_ZA
dc.contributor.authorBarnes, Karenen_ZA
dc.contributor.authorSibley, Carolen_ZA
dc.contributor.authorGuerin, Philippeen_ZA
dc.contributor.authorWhite, Nicholasen_ZA
dc.contributor.authorLindegardh, Niklasen_ZA
dc.date.accessioned2015-11-11T12:02:09Z
dc.date.available2015-11-11T12:02:09Z
dc.date.issued2010en_ZA
dc.description.abstractBACKGROUND: 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.identifier.apacitationLourens, 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/11427/14892en_ZA
dc.identifier.chicagocitationLourens, 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/11427/14892en_ZA
dc.identifier.citationLourens, 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.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
dc.identifier.urihttp://hdl.handle.net/11427/14892
dc.identifier.urihttp://dx.doi.org/10.1186/1475-2875-9-375
dc.identifier.vancouvercitationLourens 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.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDivision of Clinical Pharmacologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2010 Lourens et al; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceMalaria Journalen_ZA
dc.source.urihttp://www.malariajournal.com/en_ZA
dc.subject.otherAntimalarialsen_ZA
dc.subject.otherMalariaen_ZA
dc.subject.otherReference Standardsen_ZA
dc.titleImplementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN)en_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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