NATA accredits first Australian lab for both mobile Rapid Antigen Tests and Reverse-Transcription Polymerase Chain Reaction Testing

Media Releases September 7, 2021
NATA accredits first Australian lab for both mobile Rapid Antigen Tests and Reverse-Transcription Polymerase Chain Reaction Testing
NATA team

Melbourne’s Microbiological Diagnostic Unit Public Health Laboratory at Doherty Institute is recognised as Australia’s longest continuously serving public health laboratory

7 September, Melbourne – National Association of Testing Authorities (NATA) today announces it has accredited its first facility, Microbiological Diagnostic Unit Public Health Laboratory (MDU PHL), for both mobile Rapid Antigen Testing and mobile Reverse-Transcription Polymerase Chain Reaction (RT-PCR) testing for COVID-19 SARS-CoV-2.

With Rapid Antigen Testing (RAT) increasingly being used as a means of testing for COVID-19, due to the potential for results being returned in a more timely manner than Polymerase Chain Reaction (PCR) testing, NATA’s accreditation will provide added confidence for the public that the test is being performed to appropriate standards.

Microbiological Diagnostic Unit Public Health Laboratory (MDU PHL) sought accreditation from NATA for both mobile RT-PCR and rapid antigen testing, as a proactive step in its test to meet national and international standards.

While not as sensitive as Polymerase Chain Reaction (PCR) testing, Rapid Antigen Testing can provide a result in 15 minutes. The test involves a nasal swab being taken, just as with polymerase chain reaction (PCR) testing, and then mixed with an antibody solution. That mixed sample is then added to a test cartridge at the point of care, offering a quick turnaround time. This lower sensitivity process does not replace the necessity and importance of the gold standard PCR testing, but it does allow a testing site to perform a number of tests at speed. 

NATA supports the latest Public Health Laboratory Network (PHLN) and Communicable Disease Network Australia (CDNA) advice (updated 11 August 2021) which notes that rapid antigen tests must be undertaken in accordance with any public health orders and/or regulations of the jurisdiction where they are used.

Jennifer Evans, NATA Chief Executive Officer said: “NATA commends MDU PHL, one of our oldest members, on its mobile Rapid Antigen Testing and Reverse-Transcription Polymerase Chain Reaction testing accreditation.

“We’re already seeing increased consumer demand for Rapid Antigen Testing in certain settings across different states right now. And while they are less sensitive than Polymerase Chain Reaction (PCR) tests, NATA recognises the role RAT can have for screening COVID-19, and also the importance accreditation plays for labs and facilities by ensuring consumers and end users can have confidence in the competence of the testing service they are using.

“NATA has already accredited 161 facilities for Polymerase Chain Reaction (PCR) testing for COVID-19 in Australia which remains the gold standard for testing for SARS-CoV-2 and we are currently seeing hundreds of thousands of tests now being undertaken on a daily basis. We expect there will be more laboratories and facilities also seeking accreditation for RAT and mobile RT-PCR testing.”

MDU PHL at Doherty Institute is also the World Health Organisation (WHO) Regional Reference Laboratory for Invasive Bacterial-Vaccine Preventable Diseases (IB-VPD). 

In recent weeks, a mobile lab van from MDU PHL has been deployed to test priority samples and offer RT-PCR on-site in Shepparton, Victoria.

Commenting on the news, Prof Benjamin Howden, Director of the Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute, said: “The mobile lab van allows us to do ‘gold-standard’ and NATA Accredited RT-PCR testing on site, significantly reducing turnaround times of results to rapidly inform targeted public health responses.

“In Victoria’s current low prevalence setting, the lab van has been deployed to provide RT-PCR testing on site using the GeneXpert platform, however, we’ve taken the proactive step to gain RAT accreditation given the need to expand the scope of testing in future. In preparation, we’ve developed the lab van to be technology agnostic, meaning it is capable of embedding other rapid tests within a quality and accredited framework.

“Compared to a permanent laboratory deployment, the lab van requires enhanced risk management plans, additional training in biosafety practices unique to the mobile lab as well as driving and manoeuvring the van in a safe manner. It has been an exciting extension of scope for us, and we’ve received enthusiastic responses from our laboratory technicians who are keen to be involved.”

NATA has accredited:

161 laboratories for in-lab PCR testing

5 regional sites for Point of Care PCR testing

1 laboratory for in-lab RAT

1 new mobile laboratory for RT-PCR

1 new mobile laboratory for RAT