QA/QC service expands

7 October 2011

A prime focus of WWARN’s work is training scientists to collect antimalarial drug efficacy data of the highest quality to provide reliable evidence of resistance, if present. Proficiency testing is a vital addition to any surveillance programme, giving researchers the chance to test their skills against the global standards, receive feedback and hone their skills for working on valuable, often irreplaceable, clinical samples.

Building on the lessons learned from a successful, small-scale QA/QC programme involving 14 pharmacology and in vitro research groups, we have expanded and extended our services to support any laboratory conducting malaria pharmacology and in vitro testing. The molecular proficiency testing program, established with generous support from the United States Agency for International Development (USAID) and involving seven laboratories in the Greater Mekong Subregion, has also been expanded globally.

Pharmacology QA/QC Scheme

Three times a year, laboratories participating in the Pharmacology proficiency testing programme receive blinded samples for analysis using their own routine procedures. The QA/QC unit provides feedback on their results and advice for improving performance. Participants also receive small, pre-weighed quantities of appropriate drug, reference metabolite and internal standards from the reference material programme.  This facilitates the inter-laboratory comparison and the laboratories’ capacity to perform pharmacological studies.

The QA/QC scheme has achieved several milestones since its launch in 2009. One of the first successes, and in response to user feedback, was to identify a reliable supplier of drugs and metabolites that met the standards required for a reference material, at a competitive price. We have also learned how to store standards for longer periods. These gains have greatly reduced the cost of delivering the reference material programme and allowed us to expand the service to all qualifying laboratories. In addition, to further improve the pharmacology proficiency testing programme, WWARN will appoint a mentor to support participants in reaching an agreed level of proficiency.

"The recently-published WHO’s Global Plan for Artemisinin Resistance Containment stressed the need to improve the quality of data on antimalarial resistance. The WWARN QA/QC scheme helps researchers achieve this goal," explained Professor Niklas Lindegardh, Programme Director. "This in turn enables the malaria community to gain a more accurate and reliable picture of antimalarial drug resistance in malaria-endemic regions across the world.

"Our future plans include expanding the proficiency testing programme to new sample types, such as dried blood spots. This is really exciting and in line with new developments in analytical testing in this field. Testing laboratories will have more stable samples to work with. We will be able to send blinded test samples at ambient temperature rather than sending liquid blood samples on dry ice. It’s win-win for us all,' said Professor Lindegardh.

The Pharmacology QA/QC scheme is being accredited to international ISO standards by the Thailand Department of Science Services (DSS). "Accreditation will enhance the credibility of the programme and open doors to extend participation across the industry," said Professor Lindegardh. "Our aim now is to encourage other laboratories to join this valuable programme and really help us drive the fight against antimalarial resistance.

Apply to join the Pharmacology scheme by e-mailing QAQC [at] wwarn [dot] org

In Vitro QA/QC Scheme

Although a proficiency testing programme is not yet operational for in vitro analysis laboratories, researchers may apply to receive drug and metabolite standards from the Pharmacology reference material programme.

Malaria Molecular Proficiency Testing Programme

Plasmodium falciparum genotyping with polymorphic molecular markers is widely used to distinguish recrudescence from re-infection in antimalarial drug efficacy monitoring programmes. Laboratories carrying out these analyses can now take advantage of a new WWARN molecular proficiency testing programme.

The programme is open to any laboratory, anywhere in the world, testing dried blood spot samples using PCR-based msp1, msp2 and glurp genotyping and agarose gel electrophoresis. It is an extension of a successful scheme initiated two years ago in the Southeast Asian Greater Mekong Subregion in partnership with the United States Agency for International Development (USAID). We aim to increase participation from the current seven, Mekong-region laboratories to involve an estimated 25 to 30 molecular laboratories worldwide. 

Jeffery Smith, Coordinator, Molecular Surveillance Network, explains: “Our Molecular proficiency testing scheme provides an unbiased, non-threatening assessment of a laboratory’s ability to differentiate recrudescence from reinfection, accurately and reliably. The report and feedback empowers participants to improve their skills and to deliver a quality-assured analytical service.”

To get further information or enrol in the molecular programme, e-mail carol [dot] sibley [at] wwarn [dot] org

Initially, laboratories may participate in each programme and receive standards without charge.  WWARN plans to introduce a cost recovery scheme to ensure the scheme is sustainable whilst maintaining wide access to the services.  Participants will be notified of any changes.