New underpinning standards for improved bio-analytical measurement in infectious diseasesShort Name: Bio-stand 2, Project Number: 20SIP03
Supporting the use of neucleic acid measurements in the fight against pathogenic disease
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 will promote uptake of key outputs from AntiMicroResist. In collaboration with ISO/TC 276 and ISO/TC 212, responsible for standards in biotechnology and in vitro diagnostic (IVD) testing, a new technical specification (ISO/NP TS 5798) on the best quality practice for detecting SARS-CoV-2 will be developed. Together with ISO/TC 212 a new work item on the use of metagenomics, a NA technique for simultaneously detecting multiple pathogens, will also be 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.