Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study
Summary: There is an urgent need for rapid SARS-CoV-2 testing in hospitals to limit nosocomial spread. We report an evaluation of point of care (POC) nucleic acid amplification testing (NAAT) in 149 participants with parallel combined nasal and throat swabbing for POC versus standard lab RT-PCR test...
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| Format: | Article |
| Language: | English |
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Elsevier
2020-08-01
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| Series: | Cell Reports Medicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666379120300781 |
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Article |
| collection |
DOAJ |
| language |
English |
| format |
Article |
| sources |
DOAJ |
| author |
Dami A. Collier Sonny M. Assennato Ben Warne Nyarie Sithole Katherine Sharrocks Allyson Ritchie Pooja Ravji Matthew Routledge Dominic Sparkes Jordan Skittrall Anna Smielewska Isobel Ramsey Neha Goel Martin Curran David Enoch Rhys Tassell Michelle Lineham Devan Vaghela Clare Leong Hoi Ping Mok John Bradley Kenneth G.C. Smith Vivienne Mendoza Nikos Demiris Martin Besser Gordon Dougan Paul J. Lehner Mark J. Siedner Hongyi Zhang Claire S. Waddington Helen Lee Ravindra K. Gupta Stephen Baker John Bradley Gordon Dougan Ian Goodfellow Ravindra K. Gupta Paul J. Lehner Paul Lyons Nicholas J. Matheson Kenneth G.C. Smith Mark Toshner Michael P. Weekes Nick Brown Martin Curran Surendra Palmar Hongyi Zhang David Enoch Daniel Chapman Ashley Shaw Vivien Mendoza Sherly Jose Areti Bermperi Julie Ann Zerrudo Evgenia Kourampa Caroline Saunders Ranalie de Jesus Jason Domingo Ciro Pasquale Bensi Vergese Phoebe Vargas Marivic Fabiculana Marlyn Perales Richard Skells Lee Mynott Elizabeth Blake Amy Bates Anne-laure Vallier Alexandra Williams David Phillips Edmund Chiu Alex Overhill Nicola Ramenante Jamal Sipple Steven Frost Helena Knock Richard Hardy Emily Foster Fiona Davidson Viona Rundell Purity Bundi Richmond Abeseabe Sarah Clark Isabel Vicente |
| spellingShingle |
Dami A. Collier Sonny M. Assennato Ben Warne Nyarie Sithole Katherine Sharrocks Allyson Ritchie Pooja Ravji Matthew Routledge Dominic Sparkes Jordan Skittrall Anna Smielewska Isobel Ramsey Neha Goel Martin Curran David Enoch Rhys Tassell Michelle Lineham Devan Vaghela Clare Leong Hoi Ping Mok John Bradley Kenneth G.C. Smith Vivienne Mendoza Nikos Demiris Martin Besser Gordon Dougan Paul J. Lehner Mark J. Siedner Hongyi Zhang Claire S. Waddington Helen Lee Ravindra K. Gupta Stephen Baker John Bradley Gordon Dougan Ian Goodfellow Ravindra K. Gupta Paul J. Lehner Paul Lyons Nicholas J. Matheson Kenneth G.C. Smith Mark Toshner Michael P. Weekes Nick Brown Martin Curran Surendra Palmar Hongyi Zhang David Enoch Daniel Chapman Ashley Shaw Vivien Mendoza Sherly Jose Areti Bermperi Julie Ann Zerrudo Evgenia Kourampa Caroline Saunders Ranalie de Jesus Jason Domingo Ciro Pasquale Bensi Vergese Phoebe Vargas Marivic Fabiculana Marlyn Perales Richard Skells Lee Mynott Elizabeth Blake Amy Bates Anne-laure Vallier Alexandra Williams David Phillips Edmund Chiu Alex Overhill Nicola Ramenante Jamal Sipple Steven Frost Helena Knock Richard Hardy Emily Foster Fiona Davidson Viona Rundell Purity Bundi Richmond Abeseabe Sarah Clark Isabel Vicente Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study Cell Reports Medicine COVID-19 SARS-CoV-2 POC point of care diagnostic test nosocomial |
| author_facet |
Dami A. Collier Sonny M. Assennato Ben Warne Nyarie Sithole Katherine Sharrocks Allyson Ritchie Pooja Ravji Matthew Routledge Dominic Sparkes Jordan Skittrall Anna Smielewska Isobel Ramsey Neha Goel Martin Curran David Enoch Rhys Tassell Michelle Lineham Devan Vaghela Clare Leong Hoi Ping Mok John Bradley Kenneth G.C. Smith Vivienne Mendoza Nikos Demiris Martin Besser Gordon Dougan Paul J. Lehner Mark J. Siedner Hongyi Zhang Claire S. Waddington Helen Lee Ravindra K. Gupta Stephen Baker John Bradley Gordon Dougan Ian Goodfellow Ravindra K. Gupta Paul J. Lehner Paul Lyons Nicholas J. Matheson Kenneth G.C. Smith Mark Toshner Michael P. Weekes Nick Brown Martin Curran Surendra Palmar Hongyi Zhang David Enoch Daniel Chapman Ashley Shaw Vivien Mendoza Sherly Jose Areti Bermperi Julie Ann Zerrudo Evgenia Kourampa Caroline Saunders Ranalie de Jesus Jason Domingo Ciro Pasquale Bensi Vergese Phoebe Vargas Marivic Fabiculana Marlyn Perales Richard Skells Lee Mynott Elizabeth Blake Amy Bates Anne-laure Vallier Alexandra Williams David Phillips Edmund Chiu Alex Overhill Nicola Ramenante Jamal Sipple Steven Frost Helena Knock Richard Hardy Emily Foster Fiona Davidson Viona Rundell Purity Bundi Richmond Abeseabe Sarah Clark Isabel Vicente |
| author_sort |
Dami A. Collier |
| title |
Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study |
| title_short |
Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study |
| title_full |
Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study |
| title_fullStr |
Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study |
| title_full_unstemmed |
Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study |
| title_sort |
point of care nucleic acid testing for sars-cov-2 in hospitalized patients: a clinical validation trial and implementation study |
| publisher |
Elsevier |
| series |
Cell Reports Medicine |
| issn |
2666-3791 |
| publishDate |
2020-08-01 |
| description |
Summary: There is an urgent need for rapid SARS-CoV-2 testing in hospitals to limit nosocomial spread. We report an evaluation of point of care (POC) nucleic acid amplification testing (NAAT) in 149 participants with parallel combined nasal and throat swabbing for POC versus standard lab RT-PCR testing. Median time to result is 2.6 (IQR 2.3–4.8) versus 26.4 h (IQR 21.4–31.4, p < 0.001), with 32 (21.5%) positive and 117 (78.5%) negative. Cohen’s κ correlation between tests is 0.96 (95% CI 0.91–1.00). When comparing nearly 1,000 tests pre- and post-implementation, the median time to definitive bed placement from admission is 23.4 (8.6-41.9) versus 17.1 h (9.0–28.8), p = 0.02. Mean length of stay on COVID-19 “holding” wards is 58.5 versus 29.9 h (p < 0.001). POC testing increases isolation room availability, avoids bed closures, allows discharge to care homes, and expedites access to hospital procedures. POC testing could mitigate the impact of COVID-19 on hospital systems. |
| topic |
COVID-19 SARS-CoV-2 POC point of care diagnostic test nosocomial |
| url |
http://www.sciencedirect.com/science/article/pii/S2666379120300781 |
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doaj-618dc2c7482d47aeb29159bc9e1875ff2020-11-25T04:07:13ZengElsevierCell Reports Medicine2666-37912020-08-0115100062Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation StudyDami A. Collier0Sonny M. Assennato1Ben Warne2Nyarie Sithole3Katherine Sharrocks4Allyson Ritchie5Pooja Ravji6Matthew Routledge7Dominic Sparkes8Jordan Skittrall9Anna Smielewska10Isobel Ramsey11Neha Goel12Martin Curran13David Enoch14Rhys Tassell15Michelle Lineham16Devan Vaghela17Clare Leong18Hoi Ping Mok19John Bradley20Kenneth G.C. Smith21Vivienne Mendoza22Nikos Demiris23Martin Besser24Gordon Dougan25Paul J. Lehner26Mark J. Siedner27Hongyi Zhang28Claire S. Waddington29Helen Lee30Ravindra K. Gupta31Stephen BakerJohn BradleyGordon DouganIan GoodfellowRavindra K. GuptaPaul J. LehnerPaul LyonsNicholas J. MathesonKenneth G.C. SmithMark ToshnerMichael P. WeekesNick BrownMartin CurranSurendra PalmarHongyi ZhangDavid EnochDaniel ChapmanAshley ShawVivien MendozaSherly JoseAreti BermperiJulie Ann ZerrudoEvgenia KourampaCaroline SaundersRanalie de JesusJason DomingoCiro PasqualeBensi VergesePhoebe VargasMarivic FabiculanaMarlyn PeralesRichard SkellsLee MynottElizabeth BlakeAmy BatesAnne-laure VallierAlexandra WilliamsDavid PhillipsEdmund ChiuAlex OverhillNicola RamenanteJamal SippleSteven FrostHelena KnockRichard HardyEmily FosterFiona DavidsonViona RundellPurity BundiRichmond AbeseabeSarah ClarkIsabel VicenteDivision of Infection and Immunity, University College London, London WC1E 6BT, UK; Cambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID), Cambridge CB2 0AW, UKDiagnostics for the Real World EU, Chesterford Research Park, Saffron Walden CB10 1XL, UKCambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID), Cambridge CB2 0AW, UK; Department of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UK; Department of Medicine, University of Cambridge, Cambridge CB2 0AW, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDiagnostics for the Real World EU, Chesterford Research Park, Saffron Walden CB10 1XL, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDiagnostics for the Real World EU, Chesterford Research Park, Saffron Walden CB10 1XL, UKClinical Microbiology & Public Health Laboratory, Public Health England, Cambridge CB2 0QQ, UKClinical Microbiology & Public Health Laboratory, Public Health England, Cambridge CB2 0QQ, UKPOC Testing, Department of Pathology, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, UKPOC Testing, Department of Pathology, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UKDepartment of Medicine, University of Cambridge, Cambridge CB2 0AW, UK; National Institutes for Health Research (NIHR) Cambridge Biomedical Research Centre, Cambridge CB2 0QQ, UKCambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID), Cambridge CB2 0AW, UK; Department of Medicine, University of Cambridge, Cambridge CB2 0AW, UKNIHR Cambridge Clinical Research Facility, Cambridge CB2 0QQ, UKDepartment of Statistics, Athens University of Economics and Business, 28is Oktovriou 76, 104 34 Athens, GreeceDepartment of Haematology, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, UKCambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID), Cambridge CB2 0AW, UK; Department of Medicine, University of Cambridge, Cambridge CB2 0AW, UKCambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID), Cambridge CB2 0AW, UK; Department of Medicine, University of Cambridge, Cambridge CB2 0AW, UKMassachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USAClinical Microbiology & Public Health Laboratory, Public Health England, Cambridge CB2 0QQ, UKDepartment of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UK; Department of Medicine, University of Cambridge, Cambridge CB2 0AW, UKDiagnostics for the Real World EU, Chesterford Research Park, Saffron Walden CB10 1XL, UKCambridge Institute of Therapeutic Immunology & Infectious Disease (CITIID), Cambridge CB2 0AW, UK; Department of Infectious Diseases, Cambridge University NHS Hospitals Foundation Trust, Cambridge CB2 0QQ, UK; Department of Medicine, University of Cambridge, Cambridge CB2 0AW, UK; Africa Health Research Institute, Durban 4001, South Africa; Corresponding authorSummary: There is an urgent need for rapid SARS-CoV-2 testing in hospitals to limit nosocomial spread. We report an evaluation of point of care (POC) nucleic acid amplification testing (NAAT) in 149 participants with parallel combined nasal and throat swabbing for POC versus standard lab RT-PCR testing. Median time to result is 2.6 (IQR 2.3–4.8) versus 26.4 h (IQR 21.4–31.4, p < 0.001), with 32 (21.5%) positive and 117 (78.5%) negative. Cohen’s κ correlation between tests is 0.96 (95% CI 0.91–1.00). When comparing nearly 1,000 tests pre- and post-implementation, the median time to definitive bed placement from admission is 23.4 (8.6-41.9) versus 17.1 h (9.0–28.8), p = 0.02. Mean length of stay on COVID-19 “holding” wards is 58.5 versus 29.9 h (p < 0.001). POC testing increases isolation room availability, avoids bed closures, allows discharge to care homes, and expedites access to hospital procedures. POC testing could mitigate the impact of COVID-19 on hospital systems.http://www.sciencedirect.com/science/article/pii/S2666379120300781COVID-19SARS-CoV-2POCpoint of carediagnostic testnosocomial |