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Clinical Trial
. 2020 Aug 25;1(5):100062.
doi: 10.1016/j.xcrm.2020.100062. Epub 2020 Jul 15.

Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study

Dami A Collier  1   2 , Sonny M Assennato  3 , Ben Warne  2   4   5 , Nyarie Sithole  4 , Katherine Sharrocks  4 , Allyson Ritchie  3 , Pooja Ravji  4 , Matthew Routledge  4 , Dominic Sparkes  4 , Jordan Skittrall  4 , Anna Smielewska  4 , Isobel Ramsey  4 , Neha Goel  3 , Martin Curran  6 , David Enoch  6 , Rhys Tassell  7 , Michelle Lineham  7 , Devan Vaghela  4 , Clare Leong  4 , Hoi Ping Mok  4 , John Bradley  5   8 , Kenneth G C Smith  2   5 , Vivienne Mendoza  9 , Nikos Demiris  10 , Martin Besser  11 , Gordon Dougan  2   5 , Paul J Lehner  2   5 , Mark J Siedner  12   13 , Hongyi Zhang  6 , Claire S Waddington  4   5 , Helen Lee  3 , Ravindra K Gupta  2   4   5   14 ; CITIID-NIHR COVID BioResource Collaboration
Collaborators, Affiliations
Clinical Trial

Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study

Dami A Collier et al. Cell Rep Med. .

Abstract

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.

Keywords: COVID-19; POC; SARS-CoV-2; diagnostic test; infection control; nosocomial; point of care.

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Conflict of interest statement

The authors declare no competing interests.

Figures

None
Graphical abstract
Figure 1
Figure 1
Prospective Clinical Study Flowchart Consolidated Standards of Reporting Trials (CONSORT) Diagram PHE, Public Health England; SAMBA, simple amplification-based assay; VTM, viral transport medium;.
Figure 2
Figure 2
Kaplan-Meier Plot of the Time to Test Result under Clinical Validation Trial Conditions The time to test result in hours for the SAMBA II SARS-CoV-2 test (red) compared with the standard lab RT-PCR (black) (log rank test p < 0.001). RT-PCR, reverse transcriptase-polymerase chain reaction.
Figure 3
Figure 3
Impact of SAMBA II SARS-CoV-2 Testing on COVID Risk Stratification and Change in Use of Single-Occupancy Isolation Rooms (A) The assigned risk of COVID at initial assessment by a clinician at presentation and reassignment of COVID risk following the results of the SAMBA II SARS-CoV-2 test. Red, amber, and green represent high-, medium-, and low-risk clinical areas, respectively (p < 0.001 χ2 test). (B) The isolation type at initial assessment and following the results of the SAMBA II SARS-CoV-2 test (p < 0.001 χ2 test).
Figure 4
Figure 4
Kaplan-Meier Plots of the Time to Test Results and Definitive Ward Move Comparing SAMBA II SARS-CoV-2 Test in the Post-implementation Period with the Standard Lab RT-PCR in the Pre-implementation Period (A) The time to test result in hours for the SAMBA II SARS-CoV-2 test (red) compared with the standard lab RT-PCR (black) (log rank test p < 0.001). (B) The time to definitive ward move for SAMBA II SARS-CoV-2 POC test (red) compared with the standard lab RT-PCR (black) (log rank test p = 0.02).
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