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

Published

May 20, 2024

Author(s)

Jim Huggett, Denise O'Sullivan, Simon Cowen, Megan Cleveland, Jacob Moran-Gilad, Amanda Winter, Michael Messenger, Julian Braybrook

Abstract

Diagnostic tests were heralded as crucial during the COVID-19 pandemic with most of the key methods using bioanalytical approaches. Bioanalytical techniques can be loosely described as methods that identify and quantify larger molecules (than conventional clinical biochemistry). For infectious disease diagnosis, this typically describes the detection of the presence of pathogen derived nucleic acids, proteins or the host antibody response to said pathogen. Through genetic analysis, Nucleic Acid Amplification Tests (NAATs), like Polymerase Chain Reaction (PCR), and other molecular methods, like sequencing (that often work in combination with NAATs), enabled the ability to rapidly identify the cause of COVID-19 and provide a diagnostic response within weeks. PCR essentially made a timely response to COVID-19 possible. However, early in the pandemic this testing was largely unstandardised which, in short, meant it was unclear how well the tests were actually working. This meant results that were being used to guide interventions to stop the pandemic were of assumed accuracy. Later in 2020 the WHO published its first target product profile (TPP) outlining requirements for COVID-19 diagnostic tests to support their development and since then TPPs are becoming more commonplace in this sector. The attention placed on molecular diagnostic tests during COVID provides a useful case to aid discussion. In this manuscript we discuss conventional approaches to diagnostic evaluation and explore how they may be better tailored to diagnostic techniques like NAATs to maximise the impact of these highly versatile bioanalytical tools.

Citation

Molecular Aspects of Medicine

Pub Type

Journals

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Citation

Huggett, J. , O'Sullivan, D. , Cowen, S. , Cleveland, M. , Moran-Gilad, J. , Winter, A. , Messenger, M. and Braybrook, J. (2024), Ensuring accuracy in the development and application of nucleic acid amplification tests (NAATs) for infectious disease, Molecular Aspects of Medicine, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=956935 (Accessed October 6, 2025)