Developing and maintaining quality of COVID-19 testing through proficiency testing
An External Quality Assurance (EQA) program aims to analyse the accuracy of a laboratory’s entire testing process, from the receipt and testing of samples to the reporting of results. During this process, a number of laboratories are provided with the same material and are required to return their results to an external agency for comparison. Laboratory participation in this process is necessary to maintain accreditation and provide confidence in results.
In January 2020, the Royal College of Pathologists of Australasia Quality Assurance Program (RCPAQAP) was approached to produce an EQA program for SARS-CoV-2, the virus which causes COVID-19. We spoke to Dr. Tony Badrick, CEO of RCPAQAP, to understand more about what was involved.
"One of the reasons Australia has handled this pandemic so well is because of the strength of its health care system. This goes hand-in-hand with the pathology sector being able to ramp up testing capacity and capability as required. At RCPAQAP, our job is to support pathology testing by ensuring laboratories are getting the right answers. Normally, it would take a minimum of a year to develop, produce and dispatch an EQA program, but we did it in just over a month."
"RCPAQAP Biosecurity is a program funded by the Australian Government's Department of Health. Earlier this year, we responded to requests from both the Department of Health and from reference laboratories nationally, to produce an urgent proficiency testing program (PTP) for SARS-CoV-2. This PTP would allow laboratories to quality assure their testing therefore ensuring accurate results,” said Dr. Badrick.
RCPAQAP offered one of the first SARS-CoV-2 specific PTPs, which closed on 11th March 2020, and involved 16 public laboratories from all Australian states and territories and a select number of public and private laboratories from New Zealand. This PTP supplemented previous SARS- CoV, MERS-CoV, and other coronaviruses PTP.
Since then, several different COVID-19 related PTPs have been developed to cater to for different laboratories and testing platforms. These are available to laboratories and other testing sites, not just within Australia but worldwide. Developing a new PTP involves a number of important steps which must adhere to certain standards.
"Proficiency testing utilises reference materials that mimic the SARS-CoV-2 virus but are actually safe and non-infectious. This material must first be sourced, inactivated, validated, and tested before it can be used. In the case of SARS-CoV-2, at the time, no one outside of China had grown the virus yet, making it very difficult to develop a PTP.
“Once the material was grown here in Australia, collaborating laboratories made it available to the RCPAQAP. This material then had to be prepared and tested to ensure that all laboratories received the same material, and that it would remain stable for the duration of the testing period before being dispatched.
"It is the quality of the testing that really matters and this is what allows you to ramp up quite quickly. There are lots of countries which have had bad testing algorithms, resulting in poor results and poor patient outcomes. We have the ability to ramp up and produce quality assurance material in a very short period of time. We wouldn't be able to do that if it wasn't for the support that we have from the Australian Government," said Dr. Badrick.
A second, more detailed PTP is planned to be performed by the RCPA QAP in mid-2020. The second PTP is scheduled for distribution to a wider range of laboratories both nationally and worldwide, once testing has been extended to more laboratories.