Rapid design and implementation of an adaptive pooling workflow for SARS-CoV-2 testing in an NHS diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]

Background: Diagnostic laboratories are currently required to provide routine testing of asymptomatic staff and patients as a part of their clinical screening for SARS-CoV-2 infection. However, these cohorts display very different disease prevalence from symptomatic individuals and testing capacity...

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Autores principales:	Michael Crone, Paul Randell, Zoey Herm, Arthi Anand, Saghar Missaghian-Cully, Loren Perelman, Panagiotis Pantelidis, Paul Freemont
Formato:	article
Lenguaje:	EN
Publicado:	Wellcome 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/0726e1c139924b50b474da546f8075d3
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spelling	oai:doaj.org-article:0726e1c139924b50b474da546f8075d32021-11-15T15:27:34ZRapid design and implementation of an adaptive pooling workflow for SARS-CoV-2 testing in an NHS diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]2398-502X10.12688/wellcomeopenres.17226.1https://doaj.org/article/0726e1c139924b50b474da546f8075d32021-10-01T00:00:00Zhttps://wellcomeopenresearch.org/articles/6-268/v1https://doaj.org/toc/2398-502XBackground: Diagnostic laboratories are currently required to provide routine testing of asymptomatic staff and patients as a part of their clinical screening for SARS-CoV-2 infection. However, these cohorts display very different disease prevalence from symptomatic individuals and testing capacity for asymptomatic screening is often limited. Group testing is frequently proposed as a possible solution to address this; however, proposals neglect the technical and operational feasibility of implementation in a front-line diagnostic laboratory. Methods: Between October and December 2020, as a seven-week proof of concept, we took into account scientific, technical and operational feasibility to design and implement an adaptive pooling strategy in an NHS diagnostic laboratory in London (UK). We assessed the impact of pooling on analytical sensitivity and modelled the impact of prevalence on pooling strategy. We then considered the operational constraints to model the potential gains in capacity and the requirements for additional staff and infrastructure. Finally, we developed a LIMS-agnostic laboratory automation workflow and software solution and tested the technical feasibility of our adaptive pooling workflow. Results: First, we determined the analytical sensitivity of the implemented SARS-CoV-2 assay to be 250 copies/mL. We then determined that, in a setting with limited analyser capacity, the testing capacity could be increased by two-fold with pooling, however, in a setting with limited reagents, this could rise to a five-fold increase. These capacity increases could be realized with modest additional resource and staffing requirements whilst utilizing up to 76% fewer plastic consumables and 90% fewer reagents. Finally, we successfully implemented a plate-based pooling workflow and tested 920 patient samples using the reagents that would usually be required to process just 222 samples. Conclusions: Adaptive pooled testing is a scientifically, technically and operationally feasible solution to increase testing capacity in frontline NHS diagnostic laboratories.Michael CronePaul RandellZoey HermArthi AnandSaghar Missaghian-CullyLoren PerelmanPanagiotis PantelidisPaul FreemontWellcomearticleMedicineRScienceQENWellcome Open Research, Vol 6 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Michael Crone Paul Randell Zoey Herm Arthi Anand Saghar Missaghian-Cully Loren Perelman Panagiotis Pantelidis Paul Freemont Rapid design and implementation of an adaptive pooling workflow for SARS-CoV-2 testing in an NHS diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]
description	Background: Diagnostic laboratories are currently required to provide routine testing of asymptomatic staff and patients as a part of their clinical screening for SARS-CoV-2 infection. However, these cohorts display very different disease prevalence from symptomatic individuals and testing capacity for asymptomatic screening is often limited. Group testing is frequently proposed as a possible solution to address this; however, proposals neglect the technical and operational feasibility of implementation in a front-line diagnostic laboratory. Methods: Between October and December 2020, as a seven-week proof of concept, we took into account scientific, technical and operational feasibility to design and implement an adaptive pooling strategy in an NHS diagnostic laboratory in London (UK). We assessed the impact of pooling on analytical sensitivity and modelled the impact of prevalence on pooling strategy. We then considered the operational constraints to model the potential gains in capacity and the requirements for additional staff and infrastructure. Finally, we developed a LIMS-agnostic laboratory automation workflow and software solution and tested the technical feasibility of our adaptive pooling workflow. Results: First, we determined the analytical sensitivity of the implemented SARS-CoV-2 assay to be 250 copies/mL. We then determined that, in a setting with limited analyser capacity, the testing capacity could be increased by two-fold with pooling, however, in a setting with limited reagents, this could rise to a five-fold increase. These capacity increases could be realized with modest additional resource and staffing requirements whilst utilizing up to 76% fewer plastic consumables and 90% fewer reagents. Finally, we successfully implemented a plate-based pooling workflow and tested 920 patient samples using the reagents that would usually be required to process just 222 samples. Conclusions: Adaptive pooled testing is a scientifically, technically and operationally feasible solution to increase testing capacity in frontline NHS diagnostic laboratories.
format	article
author	Michael Crone Paul Randell Zoey Herm Arthi Anand Saghar Missaghian-Cully Loren Perelman Panagiotis Pantelidis Paul Freemont
author_facet	Michael Crone Paul Randell Zoey Herm Arthi Anand Saghar Missaghian-Cully Loren Perelman Panagiotis Pantelidis Paul Freemont
author_sort	Michael Crone
title	Rapid design and implementation of an adaptive pooling workflow for SARS-CoV-2 testing in an NHS diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]
title_short	Rapid design and implementation of an adaptive pooling workflow for SARS-CoV-2 testing in an NHS diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]
title_full	Rapid design and implementation of an adaptive pooling workflow for SARS-CoV-2 testing in an NHS diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]
title_fullStr	Rapid design and implementation of an adaptive pooling workflow for SARS-CoV-2 testing in an NHS diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]
title_full_unstemmed	Rapid design and implementation of an adaptive pooling workflow for SARS-CoV-2 testing in an NHS diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]
title_sort	rapid design and implementation of an adaptive pooling workflow for sars-cov-2 testing in an nhs diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]
publisher	Wellcome
publishDate	2021
url	https://doaj.org/article/0726e1c139924b50b474da546f8075d3
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Rapid design and implementation of an adaptive pooling workflow for SARS-CoV-2 testing in an NHS diagnostic laboratory: a proof-of-concept study [version 1; peer review: 2 approved]

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