The Pharmacology Proficiency Testing (PT) programme has now been granted official Proficiency Testing Provider accreditation according to ISO 17043:2010. This accreditation provides the team with independent verification of the high standard of quality assurance measures implemented to provide proficiency test samples for 13 antimalarial drugs and metabolites.
The WWARN Pharmacology Proficiency Testing (PT) Programme assesses the ability of a participating laboratory to quantify malaria drug levels in patient blood samples, resolve any technical problems and achieve lasting improvements. In so doing, they increase the reliability of published antimalarial pharmacokinetic (PK)/pharmacodynamics (PD) data and enable pooled individual patient data analyses, such as those facilitated by WWARN.
- Once a year, participating laboratories receive blinded samples, which are analysed in two cycles over the following year
- Free, pre-weighed quantities of appropriate reference materials – malaria drug, reference metabolites and internal standards – are supplied to laboratories participating in the WWARN Reference Material scheme
- Laboratories carry out analyses using their choice of analytical method, ideally those used in routine analysis
- Results are reported to the QA/QC Unit within two weeks of a cycle ending
- The QA/QC Unit carries out statistical analysis of submitted results, quantifying each laboratory’s performance by measuring deviation of measured results from assigned values - the concentration used for all calculations
- Participants receive reports after each cycle which combines anonymised results from all laboratories. Using a confidential security code, a laboratory is able to identify their own results and to judge their proficiency against the wider group
- Each laboratory receives individual feedback and advice
- The QA/QC Unit is seeking accreditation from the Thailand Department of Science Services for the PT scheme to international ISO standard 17043.
Fifteen pharmacology laboratories from around the globe have joined the Pharmacology PT scheme (to May 2014). Eleven laboratories have received blinded samples for chloroquine/desethylchloroquine, Dihydroartemisinin/Artesunate, Lumefantrine/debutyl-lumefantrine, Mefloquine/carboxymefloquine, Amodiaquine/desethylamodiaquine, Primaquine/carboxyprimaquine and piperaquine since the scheme was launched in 2010.
Labs participating in pharmacology proficiency testing
For more information or to enrol
Read our brochure and Malaria Journal article, or contact Chris Lourens, Pharmacology EQA/EQC Manager by email to QAQC@wwarn.org