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Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital: a prospective, interventional, non-randomised, controlled study (COV-19POC)

Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital: a prospective, interventional, non-randomised, controlled study (COV-19POC)
Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital: a prospective, interventional, non-randomised, controlled study (COV-19POC)
Background

The management of the COVID-19 pandemic is hampered by long delays associated with centralised laboratory PCR testing. In hospitals, these delays lead to poor patient flow and nosocomial transmission. Rapid, accurate tests are therefore urgently needed in preparation for the next wave of the pandemic.

Methods

We did a prospective, interventional, non-randomised, controlled study of molecular point-of-care testing in patients aged 18 years or older presenting with suspected COVID-19 to the emergency department or other acute areas of Southampton General Hospital during the first wave of the pandemic in the UK. Nose and throat swab samples taken at admission from patients in the point-of-care testing group were tested with the QIAstat-Dx Respiratory SARS-CoV-2 Panel. Samples taken from patients in a contemporaneous control group were tested by laboratory PCR. The primary outcome was time to results in the full cohort. This study is registered with ISRCTN (ISRCTN14966673) and is completed.

Findings

Between March 20 and April 29, 2020, 517 patients were assessed for eligibility, of whom 499 were recruited to the point-of-care testing group and tested by the QIAstat-Dx Respiratory SARS-CoV-2 Panel. 555 contemporaneously identified patients were included in the control group and tested by laboratory PCR. The two groups were similar with regard to the distribution of sex, age, and ethnicity. 197 (39%) patients in the point-of-care testing group and 155 (28%) in the control group tested positive for COVID-19 (difference 11·5% [95% CI 5·8–17·2], p=0·0001). Median time to results was 1·7 h (IQR 1·6–1·9) in the point-of-care testing group and 21·3 h (16·0–27·9) in the control group (difference 19·6 h [19·0–20·3], p<0·0001). A Cox proportional hazards regression model controlling for age, sex, time of presentation, and severity of illness also showed that time to results was significantly shorter in the point-of-care testing group than in the control group (hazard ratio 4023 [95% CI 545–29 696], p<0·0001).

Interpretation

Point-of-care testing is associated with large reductions in time to results and could lead to improvements in infection control measures and patient flow compared with centralised laboratory PCR testing.

Funding

University Hospitals Southampton NHS Foundation Trust.

2213-2600
1192-1200
Brendish, Nathan
a8a4189e-01eb-4ab3-933e-a24cd188a4d7
Poole, Stephen
440d7904-ab72-469c-892b-c910cd1cb19b
Naidu, Vasanth
df9bd215-344a-43b6-b568-60c783353fa9
Mansbridge, Christopher
08cc08d1-309a-4947-a07e-dceb19436c8e
Norton, Nicholas
14bdade9-e59d-4b4a-a87f-ddb74d86d725
Wheeler, Helen
9ec21ee3-2e24-40c7-b342-64a2c371ef7a
Presland, Laura
f9595a32-b871-4d73-8444-dd0fffc08592
Kidd, Stephen
1409c55c-35d2-4a0b-8ef2-2370e6bf1dee
Cortes, Nicholas
28c043ce-05bf-433e-a0da-2e6ae8de46c5
Borca, Florina
31fc3965-6bcf-4fd6-85bc-8b0f99f62473
Phan, Hang
2811b94c-62b7-459d-9cc1-c88057008e3b
Babbage, Gavin
d2036377-f36a-4a4a-8634-4b0394dffe28
Visseaux, Benoit
17f8a100-b443-4861-b609-87f004ce1160
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f
Brendish, Nathan
a8a4189e-01eb-4ab3-933e-a24cd188a4d7
Poole, Stephen
440d7904-ab72-469c-892b-c910cd1cb19b
Naidu, Vasanth
df9bd215-344a-43b6-b568-60c783353fa9
Mansbridge, Christopher
08cc08d1-309a-4947-a07e-dceb19436c8e
Norton, Nicholas
14bdade9-e59d-4b4a-a87f-ddb74d86d725
Wheeler, Helen
9ec21ee3-2e24-40c7-b342-64a2c371ef7a
Presland, Laura
f9595a32-b871-4d73-8444-dd0fffc08592
Kidd, Stephen
1409c55c-35d2-4a0b-8ef2-2370e6bf1dee
Cortes, Nicholas
28c043ce-05bf-433e-a0da-2e6ae8de46c5
Borca, Florina
31fc3965-6bcf-4fd6-85bc-8b0f99f62473
Phan, Hang
2811b94c-62b7-459d-9cc1-c88057008e3b
Babbage, Gavin
d2036377-f36a-4a4a-8634-4b0394dffe28
Visseaux, Benoit
17f8a100-b443-4861-b609-87f004ce1160
Ewings, Sean
326656df-c0f0-44a1-b64f-8fe9578ca18a
Clark, Tristan
712ec18e-613c-45df-a013-c8a22834e14f

Brendish, Nathan, Poole, Stephen, Naidu, Vasanth, Mansbridge, Christopher, Norton, Nicholas, Wheeler, Helen, Presland, Laura, Kidd, Stephen, Cortes, Nicholas, Borca, Florina, Phan, Hang, Babbage, Gavin, Visseaux, Benoit, Ewings, Sean and Clark, Tristan (2020) Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital: a prospective, interventional, non-randomised, controlled study (COV-19POC). The Lancet Respiratory Medicine, 8 (12), 1192-1200. (doi:10.1016/S2213-2600(20)30454-9).

Record type: Article

Abstract

Background

The management of the COVID-19 pandemic is hampered by long delays associated with centralised laboratory PCR testing. In hospitals, these delays lead to poor patient flow and nosocomial transmission. Rapid, accurate tests are therefore urgently needed in preparation for the next wave of the pandemic.

Methods

We did a prospective, interventional, non-randomised, controlled study of molecular point-of-care testing in patients aged 18 years or older presenting with suspected COVID-19 to the emergency department or other acute areas of Southampton General Hospital during the first wave of the pandemic in the UK. Nose and throat swab samples taken at admission from patients in the point-of-care testing group were tested with the QIAstat-Dx Respiratory SARS-CoV-2 Panel. Samples taken from patients in a contemporaneous control group were tested by laboratory PCR. The primary outcome was time to results in the full cohort. This study is registered with ISRCTN (ISRCTN14966673) and is completed.

Findings

Between March 20 and April 29, 2020, 517 patients were assessed for eligibility, of whom 499 were recruited to the point-of-care testing group and tested by the QIAstat-Dx Respiratory SARS-CoV-2 Panel. 555 contemporaneously identified patients were included in the control group and tested by laboratory PCR. The two groups were similar with regard to the distribution of sex, age, and ethnicity. 197 (39%) patients in the point-of-care testing group and 155 (28%) in the control group tested positive for COVID-19 (difference 11·5% [95% CI 5·8–17·2], p=0·0001). Median time to results was 1·7 h (IQR 1·6–1·9) in the point-of-care testing group and 21·3 h (16·0–27·9) in the control group (difference 19·6 h [19·0–20·3], p<0·0001). A Cox proportional hazards regression model controlling for age, sex, time of presentation, and severity of illness also showed that time to results was significantly shorter in the point-of-care testing group than in the control group (hazard ratio 4023 [95% CI 545–29 696], p<0·0001).

Interpretation

Point-of-care testing is associated with large reductions in time to results and could lead to improvements in infection control measures and patient flow compared with centralised laboratory PCR testing.

Funding

University Hospitals Southampton NHS Foundation Trust.

Text
COV19POC paper 09-09-20 - Accepted Manuscript
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More information

Accepted/In Press date: 8 September 2020
e-pub ahead of print date: 8 October 2020

Identifiers

Local EPrints ID: 443679
URI: http://eprints.soton.ac.uk/id/eprint/443679
ISSN: 2213-2600
PURE UUID: 18b29086-b7ea-4086-b972-f126e821d504
ORCID for Nathan Brendish: ORCID iD orcid.org/0000-0002-9589-4937
ORCID for Sean Ewings: ORCID iD orcid.org/0000-0001-7214-4917
ORCID for Tristan Clark: ORCID iD orcid.org/0000-0001-6026-5295

Catalogue record

Date deposited: 09 Sep 2020 16:30
Last modified: 07 Oct 2021 04:03

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