Nucleic acid testing (NAT) is one of the most sensitive methods available for detecting viral and other pathogenic organisms in blood. NRL’s 2NAT Program screens donated plasma for two specific viral pathogens: hepatitis A virus and human parvovirus B19. 

The program is performed on plasma samples received fromAustralian Red Cross Lifeblood on behalf of CSL Behring – a global leader in plasma-derived therapies – that is then used to treat rare and serious conditions, and to support transplantation and critical care. Ensuring Australia’s plasma supply meets the highest global regulatory standards is not optional, it is critical. 

To deliver this program, NRL commissioned an entirely new, purpose-built, high-throughput pathology screening laboratory in Notting Hill, Victoria – operating under a Good Manufacturing Practice (GMP) licence issue by the TGA. 

This was no small undertaking. All facility fit-out, equipment installation, and process validation activities had to be completed before a single sample could be tested. The careful planning and collaboration across multiple stakeholder organisations – including Roche Australia, the TGA and the National Blood Authority – brought this complex program from concept to go-live in early April 2025.

Since going live, the Notting Hill laboratory team has worked closely with staff at NRL’s Fitzroy site to oversee the testing of approximately 150,000 samples every month. 

This means that the just over 2 million blood donations have now been screened since going live with the program, helping to ensure the safety of the plasma-derived products that patients rely on for their health and survival. Plans are already underway to further streamline testing processes as the program matures, with NRL committed to expanding the scientific services it offers to both the Australian and International communities. 

The successful execution of the 2NAT Program represents a significant step forward for NRL and SVI – demonstrating the organisation’s capacity to take on large-scale programs that directly impact public health. 

It is the result of more than 12 months of careful planning,  collaboration, and the expertise and dedication of the teams at both Notting Hill and Fitzroy. 

This National Blood Donor Week, NRL thanks every donor whose generosity makes plasma-derived therapies possible. Their contributions help ensure patients can access the treatments they need, when they need them.  

To Australian Red Cross Lifeblood, CSL Behring, the TGA, Roche Australia, and the National Blood Authority – thank you for the trust, oversight, and collaboration that made this program a reality.