The Coronavirus Standards Working Group's roadmap for improved population testing

Tim Mercer¹, Neil Almond², Michael A Crone^{3

4

5}, Patrick S G Chain⁶, Alina Deshpande⁶, Deepa Eveleigh⁷, Paul Freemont^{3

4

5}, Sebastien Fuchs⁸, Russell Garlick⁹, Jim Huggett^{10

11}, Martin Kammel^{12

13}, Po-E Li⁶, Mojca Milavec¹⁴, Elizabeth M Marlowe¹⁵, Denise M O'Sullivan^{10

11}, Mark Page², Gary A Pestano¹⁶, Sara Suliman^{17

18}, Birgitte Simen¹⁹, John J Sninsky²⁰, Lynne Sopchak²⁰, Cristina M Tato²¹, Peter M Vallone²², Jo Vandesompele²³, Thomas J White²⁴, Heinz Zeichhardt^{12

13

25}, Marc Salit^{26

27

28}

Affiliations

¹ Australian Institute for Bioengineering and Nanotechnology, University of Queensland, St Lucia, Queensland, Australia.
² Medicines and Healthcare Products Regulatory Agency, Potters Bar, UK.
³ London Biofoundry, Imperial College Translation and Innovation Hub, London, UK.
⁴ Section of Structural and Synthetic Biology, Department of Infectious Disease, Imperial College London, London, UK.
⁵ UK Dementia Research Institute Centre for Care Research and Technology, Imperial College London, London, UK.
⁶ Biosecurity and Public Health, Bioscience Division, Los Alamos National Laboratory, Los Almos, NM, USA.
⁷ Bio-techne, Inc, Austin, TX, USA.
⁸ Western University of Health Sciences, College of Osteopathic Medicine of the Pacific, Pomona, CA, USA.
⁹ LGC Clinical Diagnostics, Milford, MA, USA.
¹⁰ National Measurement Laboratory, LGC, Teddington, UK.
¹¹ School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.
¹² INSTAND e.V. Society for Promoting Quality Assurance in Medical Laboratories, Duesseldorf, Germany.
¹³ GBD Gesellschaft fuer Biotechnologische Diagnostik mbH, Berlin, Germany.
¹⁴ Department of Biotechnology and Systems Biology, National Institute of Biology, Ljubljana, Slovenia.
¹⁵ Quest Diagnostic Infectious Disease, San Juan Capistrano, CA, USA.
¹⁶ Biodesix Inc, Boulder, CO, USA.
¹⁷ Brigham and Women's Hospital, Division of Rheumatology, Inflammation and Immunity, Harvard Medical School, Boston, MA, USA.
¹⁸ Zuckerberg San Francisco General Hospital, Division of Experimental Medicine, University of California San Francisco, San Francisco, CA, USA.
¹⁹ Ginkgo Bioworks, Boston, MA, USA.
²⁰ SPARK, Stanford University, Stanford, CA, USA.
²¹ Chan Zuckerberg Biohub, San Francisco, CA, USA.
²² Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD, USA.
²³ CellCarta, Zwijnaarde, Belgium.
²⁴ Human Rights Center, School of Law, University of California, Berkeley, CA, USA.
²⁵ IQVD GmbH, Institut fuer Qualitaetssicherung in der Virusdiagnostik, Berlin, Germany.
²⁶ Departments of Pathology and Bioengineering, Stanford University, Stanford, CA, USA. msalit@stanford.edu.
²⁷ Joint Initiative for Metrology in Biology, SLAC National Accelerator Laboratory, Menlo Park, CA, USA. msalit@stanford.edu.
²⁸ MITRE Corporation, McLean, VA, USA. msalit@stanford.edu.

PMID: 36323792
PMCID: PMC9628457
DOI: 10.1038/s41587-022-01538-1

The Coronavirus Standards Working Group's roadmap for improved population testing

Tim Mercer et al. Nat Biotechnol. 2022 Nov.

. 2022 Nov;40(11):1563-1568.

doi: 10.1038/s41587-022-01538-1.

Authors

Affiliations

¹ Australian Institute for Bioengineering and Nanotechnology, University of Queensland, St Lucia, Queensland, Australia.
² Medicines and Healthcare Products Regulatory Agency, Potters Bar, UK.
³ London Biofoundry, Imperial College Translation and Innovation Hub, London, UK.
⁴ Section of Structural and Synthetic Biology, Department of Infectious Disease, Imperial College London, London, UK.
⁵ UK Dementia Research Institute Centre for Care Research and Technology, Imperial College London, London, UK.
⁶ Biosecurity and Public Health, Bioscience Division, Los Alamos National Laboratory, Los Almos, NM, USA.
⁷ Bio-techne, Inc, Austin, TX, USA.
⁸ Western University of Health Sciences, College of Osteopathic Medicine of the Pacific, Pomona, CA, USA.
⁹ LGC Clinical Diagnostics, Milford, MA, USA.
¹⁰ National Measurement Laboratory, LGC, Teddington, UK.
¹¹ School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.
¹² INSTAND e.V. Society for Promoting Quality Assurance in Medical Laboratories, Duesseldorf, Germany.
¹³ GBD Gesellschaft fuer Biotechnologische Diagnostik mbH, Berlin, Germany.
¹⁴ Department of Biotechnology and Systems Biology, National Institute of Biology, Ljubljana, Slovenia.
¹⁵ Quest Diagnostic Infectious Disease, San Juan Capistrano, CA, USA.
¹⁶ Biodesix Inc, Boulder, CO, USA.
¹⁷ Brigham and Women's Hospital, Division of Rheumatology, Inflammation and Immunity, Harvard Medical School, Boston, MA, USA.
¹⁸ Zuckerberg San Francisco General Hospital, Division of Experimental Medicine, University of California San Francisco, San Francisco, CA, USA.
¹⁹ Ginkgo Bioworks, Boston, MA, USA.
²⁰ SPARK, Stanford University, Stanford, CA, USA.
²¹ Chan Zuckerberg Biohub, San Francisco, CA, USA.
²² Biomolecular Measurement Division, National Institute of Standards and Technology, Gaithersburg, MD, USA.
²³ CellCarta, Zwijnaarde, Belgium.
²⁴ Human Rights Center, School of Law, University of California, Berkeley, CA, USA.
²⁵ IQVD GmbH, Institut fuer Qualitaetssicherung in der Virusdiagnostik, Berlin, Germany.
²⁶ Departments of Pathology and Bioengineering, Stanford University, Stanford, CA, USA. msalit@stanford.edu.
²⁷ Joint Initiative for Metrology in Biology, SLAC National Accelerator Laboratory, Menlo Park, CA, USA. msalit@stanford.edu.
²⁸ MITRE Corporation, McLean, VA, USA. msalit@stanford.edu.

PMID: 36323792
PMCID: PMC9628457
DOI: 10.1038/s41587-022-01538-1

No abstract available

PubMed Disclaimer

Conflict of interest statement

R.G. is an employee and shareholder of LGC Clinical Diagnostics. G.A.P. is an employee and shareholder in Biodesix. B.B.S is an employee of, and has received stock and RSU grants from, Ginkgo Bioworks, Inc. J.V. owns stock in and is CSO at InActiv Blue bv. T.J.W. is a consultant for Biodesix. M.S. is a shareholder in Viridae, Inc.

Figures

**Fig. 1. Standards needed for the SARS-CoV-2 testing process.**
a–c, Schematic diagram illustrating the steps in the molecular (a), antigen (b) and serological (c) testing process, which can be classified into pre-analytical (yellow), analytical (green) and post-analytical (blue) stages. Additional test development (yellow) is performed prior to manufacture. The lower panel describes the range of standards available for validating test development, processes and results.

**Fig. 2. Schematic diagram illustrates key milestones in the development of testing and standards during the COVID-19 pandemic.**
Understanding these milestones can assist in preparing for current and future public health emergencies.

See this image and copyright information in PMC

References

1. WHO/BS.2020.2402 Collaborative Study for the Establishment of a WHO International Standard for SARS-CoV-2 RNA (WHO, 2020).
1. Kristiansen PA, et al. Lancet. 2021;397:1347–1348. doi: 10.1016/S0140-6736(21)00527-4. - DOI - PMC - PubMed
1. Bossuyt PM. J. Clin. Epidemiol. 2020;126:172–176. doi: 10.1016/j.jclinepi.2020.06.037. - DOI - PMC - PubMed
1. Woloshin S, Patel N, Kesselheim AS. N. Engl. J. Med. 2020;383:e38. doi: 10.1056/NEJMp2015897. - DOI - PubMed
1. Takahashi S, Greenhouse B, Rodríguez-Barraquer I. J. Infect. Dis. 2020;222:1772–1775. doi: 10.1093/infdis/jiaa523. - DOI - PMC - PubMed

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The Coronavirus Standards Working Group's roadmap for improved population testing

Affiliations

The Coronavirus Standards Working Group's roadmap for improved population testing

Authors

Affiliations

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources