June 2024

Ensuring accuracy in the development and application of nucleic acid amplification tests (NAATs) for infectious disease

The 100 Days Mission to respond to a future pandemic threat requires a three-pronged strategy; effective diagnostics, therapeutics and vaccines. Of the three, diagnostics tests represents the first, and potentially only, line of defence in the management of infectious disease outbreaks. Yet diagnostics are also the most poorly supported in terms of funding, research or provision of a wider standardisation infrastructure to underpin translation and scaled application. During COVID-19, bioanalytical diagnostic techniques (like PCR and lateral flow tests) were widely discussed across the media, public and professionals around the world in other clinical diagnostic fields, such as precision medicine and foetal testing. As such, molecular diagnostic techniques are coming under increased scrutiny from guidance infrastructure and regulators.

Experts from the National Measurement Laboratory (NML) at LGC (Jim Huggett, Denise O'Sullivan, Simon Cowen and Julian Braybrook) have collaborated with colleagues across the diagnostic community. 'Ensuring accuracy in the development and application of nucleic acid amplification tests (NAATs) for infectious disease' discusses learnings from the COVID-19 pandemic and offers alternative approaches to conventional diagnostic evaluations for infectious disease, proposing a series of recommendations for diagnostic performance assessment to aid decisions as part of an emergency infectious disease outbreak and meet increased regulatory requirements.  

“Without advanced sequencing and PCR, our response to COVID-19 would have been very different. If diagnostics are elevated in importance alongside therapeutics and vaccines, we will be better placed to address future pandemic threats and to deliver the wider medical diagnostic advancements many predict.”

Dr Jim Huggett, Director, Biological Metrology, National Measurement Laboratory