<p><em>Supporting the use of nucleic acid measurements in the fight against pathogenic disease</em></p>
Supporting the use of nucleic acid measurements in the fight against pathogenic disease
The project
Nucleic acid (NA) based tests are used to identify and quantify the genetic material from bacteria and viruses to diagnose and monitor infectious diseases. A lack of higher order reference materials and methodology has impacted on their regulatory development, accreditation, and compliance, compromising the efficacy of diagnostic tests potentially directly affecting patient safety.
EMPIR project New underpinning standards for improved bio-analytical measurement in infectious diseases (20SIP03, Bio-stand 2) has developed a new technical specification on best practice for detecting SARS-CoV-2 (COVID-19).
This project is promoting the uptake of key outputs of the earlier EMPIR project Novel materials and methods for the detection, traceable monitoring and evaluation of antimicrobial resistance (15HLT07, AntiMicroResist) which developed methodology and guidelines for achieving traceability and comparability using nucleic acid (NA) for pathogen detection.
The resulting new standards will provide guidelines for evaluating and ensuring the quality of PCR and other genetic analysis for monitoring SARS-CoV-2, the causative agent of the COVID-19 pandemic, and for future pandemic preparedness. The diagnostic and testing industries will also be supported in demonstrating compliance with quality and regulatory requirements, ultimately improving patient safety in pathogenic diseases.
Published technical specification
ISO/TS 5798:2022 In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods provides guidelines for evaluating and ensuring the quality of molecular diagnosis of infectious diseases specifically to support the ISO/TC 276 (Biotechnology) and ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems) joint working group. Continued work of the joint working group is planned for preparation of a standard describing detection of emerging SARS-CoV-2 variants.
Jim Huggett from the National Measurement Laboratory (NML) at LGC, and Principal Investigator in the EMPIR project, said
‘This initiative allowed the NML and PTB to contribute to the development of this important technical specification. We were able to champion the inclusion of routes for standardisation during a pandemic response and highlighted the need to be very aware of how variants of concern may be diagnosed differently with an established test’.
This EMPIR project is co-funded by the European Union's Horizon 2020 research and innovation programme and the EMPIR Participating States
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