The Application of Digital PCR as a Reference Measurement Procedure to Support the Accuracy of Quality Assurance for Infectious Disease Molecular Diagnostic Testing
This work demonstrates how RT-dPCR can provide reference values for whole virus materials for NAAT quality assurance. RT-dPCR values guided EQA control material selection and provided EQA participants with traceability to RNA copy number delivered through the RMP. This approach can be used to support routine reference material use as well as to standardize quality assurance for NAATs where established reference materials are not available, such as in disease outbreaks.
Authors
- Denise M. O’Sullivan (ORCID: https://orcid.org/0000-0001-8915-7984)
- Alison S. Devonshire (ORCID: https://orcid.org/0000-0003-4960-5468)
- Laura Vierbaum (ORCID: https://orcid.org/0000-0002-3492-9796)
- Martin Kammel (ORCID: https://orcid.org/0000-0002-2011-086X)
- Esmeralda Valiente (ORCID: https://orcid.org/0000-0002-5262-4697)
- Ingo Schellenberg
- Peter M. Vallone (ORCID: https://orcid.org/0000-0002-8019-6204)
- A. Kummrow (ORCID: https://orcid.org/0000-0002-2536-1377)
- Heinz Zeichhardt (ORCID: https://orcid.org/0000-0001-9571-8995)
- Jim F. Huggett (ORCID: https://orcid.org/0000-0002-0945-1911)
- Mojca Milavec (ORCID: https://orcid.org/0000-0002-5794-2109)
- Samreen Falak (ORCID: https://orcid.org/0000-0002-8454-7884)
- Megan H. Cleveland (ORCID: https://orcid.org/0000-0002-5584-9314)
- Rainer Macdonald (ORCID: https://orcid.org/0000-0002-4719-5349)
- Simon Cowen (ORCID: https://orcid.org/0000-0002-3305-369X)
- Gerwyn M. Jones (ORCID: https://orcid.org/0000-0003-3693-4844)
- Eloise J. Busby (ORCID: https://orcid.org/0000-0002-9821-9267)
Institutions
- Physikalisch-Technische Bundesanstalt (DE)
- National Institute of Standards and Technology (US)
- National Physical Laboratory (GB)
- University of Surrey (GB)
- Physical Measurement Laboratory (US)
- National Institute of Biology (SI)
- Material Measurement Laboratory (US)
Publication Details
- Journal
- Clinical Chemistry
- Published
- 2024-12-26
- DOI
- https://doi.org/10.1093/clinchem/hvae187
- Citations
- 11
- Primary Topic
- SARS-CoV-2 detection and testing
- Type
- article
- Field-Weighted Citation Impact
- 4.28
Funders
- National Institute of Standards and Technology