New underpinning standards for improved bio-analytical measurement in infectious diseases

Antibiotic resistant bacteria could contribute to 10 million deaths per year by 2050, not including those dying from viral infections. Nucleic acid (NA)-based tests are used to identify or quantify both bacteria and viruses and are the main method for detecting SARS-CoV-2, causative of COVID-19.

A lack of higher order reference materials and methodology in this area has impacted on regulatory development, accreditation and compliance, compromising the efficacy of diagnostic tests and ultimately patient safety. The EMPIR project AntiMicroResist developed methodology and guidelines for achieving traceability and comparability using NA for pathogen detection. However, these results required incorporating into international standards to support use in the clinical management of infectious diseases.

Supported by the German standards organisation DIN this project has promoted uptake of key outputs from AntiMicroResist. In collaboration with ISO/TC 212, responsible for standards in in vitro diagnostic (IVD) testing, a new technical specification (ISO/NP TS 5798) on the best quality practice for detecting SARS-CoV-2 has been developed. Together with ISO/TC 212 a new work item on the use of metagenomics, a NA technique for simultaneously detecting multiple pathogens, has also been developed.

Outputs will be disseminated to clinical and IVD industrial sectors through best practice guidelines, webinars and presentations.

The resulting new standards will provide guidelines for evaluating and ensuring the quality of NA analysis for monitoring infectious diseases, including the response to the COVID-19 pandemic. The diagnostic and testing industries will also be supported in compliance with quality and regulatory requirements, ultimately improving patient safety in the area of pathogenic diseases.