WWARN Proficiency Testing (PT) users say programme impact is far reaching

Following the programme’s accreditation last year by the International Organization for Standardization (ISO), several participants highlighted its value to their analyses of new and existing malaria treatments.

Launched in 2010 and serving up to 18 laboratories around the world, the PT Programme sends ‘blind’ plasma samples containing an unknown antimalarial drug to participating labs which must then identify the correct drug and measure the concentration. WWARN evaluates the results. 

The PT service is part of WWARN’s External Quality Assurance (EQA) Programme, which also provides reference materials – such as pre-weighted samples of antimalarial drugs and common drug metabolites – to 61 participating laboratories free of charge. WWARN is the only designated provider of these external quality control services for antimalarials worldwide.

Dr Pattaraporn Vanachayangkul, who leads the Pharmacology and Bioanalytical Laboratory section within the 70-person Department of Immunology and Medicine at the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok, has incorporated the PT Programme into their ongoing disease surveillance and antimalarial drug development efforts, which includes routine analyses of both human and non-clinical samples.

“The programme helps us a lot”, said Vanachayangkul. “Our participation in the PT Programme gives us definitive knowledge that we can reliably and accurately identify and quantitate drugs in almost any sample matrix, even many minor drug-metabolites.”

By participating in the programme, Vanachayangkul said her staff can easily identify issues and trouble-shoot if inconsistencies arise. “Our participation in the Programme gives us and our partners, whether internal or external, confidence in the quality of our work, and that our data is accurate and reliable,” said Vanachayangkul, adding that her laboratory frequently uses WWARN’s reference materials in its work, including to prepare calibration stocks.

Dr Markus Winterberg, of the Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok, described a similar method-optimising approach at his clinical pharmacology laboratory, which analyses human antimalarial samples taken from around the world by MORU researchers and other clients, including the World Health Organization.

MORU’s laboratory is ISO accredited (17043:2010), which is important to its globally facing partners such as the WHO and US Food and Drug Administration (FDA), Winterberg said. But this also means the MORU lab must receive external quality assurance from an ISO-accredited provider. “They will not accredit us if we don’t have proficiency testing”, said Winterberg, who described WWARN’s ISO-accredited service as vital. “To my knowledge, there is no other programme that provides what WWARN does for antimalarial quality assurance.”

Several laboratories said they might have to provide their own quality control if WWARN did not offer the service – but this option is not ideal.

Citing the huge financial and patient risk of not using proper external quality assurance during clinical trials which often cost millions of dollars and span across many countries, Winterberg said programmes such as WWARN’s help to ensure the integrity of the research process overall. “If you don’t have external quality assurance you might risk reporting wrong results, thereby jeopardising the entire trial”, Winterberg said.

Chris Lourens, EQA Programme Manager, said that some laboratories have had more difficulties than others. Systematic errors are common and remain constant or vary in a predictable way over a series of measurements – but they can be corrected only if they are detected, Lourens said.

“In many cases, they wouldn’t have known about these kinds of problems unless their concentrations were assessed from outside”, said Lourens, whose team sends the PT samples to participating laboratories in a single batch each year. The only cost to participants is shipping.

Looking to the future, participating laboratories have expressed interest in WWARN expanding the service to include other types of samples, including antibiotics and other drugs. Others have requested that WWARN create a forum for participants to troubleshoot common analytical and measurement challenges. “We are definitely interested in doing more, but in the end it will come down to funding,” Lourens said.

If you are interested in participating in the EQA programme or would like to find out more information, please contact EQA Manager Chris Lourens by email: QAQC@wwarn.org