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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)
33 Pages Posted: 27 Aug 2020More...
Background: The management of the COVID-19 pandemic is hampered by the long delays associated with centralised laboratory PCR testing. In hospitals this leads to poor patient flow and nosocomial transmission. Rapid, accurate tests are therefore urgently needed for the next wave.
Methods: We performed a prospective, interventional, non-randomised, controlled study of molecular point-of-care testing (POCT) in adults presenting to hospital with suspected COVID-19. Intervention group patients were tested using the QIAstat-Dx Respiratory SARS-CoV-2 Panel at the point-of-care and control patients were tested using laboratory PCR. The primary outcome was time to results. Secondary outcomes included infection control and diagnostic accuracy measures.
Findings: 499 patients were tested by POCT and 555 control patients were tested using laboratory PCR. Median (IQR) time to results with POCT was 1.7 (1.6 to 1.9) hours versus 21.3 (16.0 to 27.9) hours in the control group (difference of 19.6 hours, 95%CI 19.0 to 20.3; p<0.0001). Median (IQR) time to arrival in definitive clinical area (i.e. COVID-19 positive or negative ward) was 8.0 (6.0 to 15.0) hours in the POCT group versus 28.8 (23.5 to 38.9) hours in the control group, difference of 20.8 hours (96%CI 18.4 to 21.2; p<0.0001). Sensitivity of the QIAstat-Dx SARS-CoV-2 assay was 99.4% (95%CI 96.9 to 100) compared to 88.1% (95%CI 82.4 to 92.5) with laboratory PCR.
Interpretation: POCT was associated with large reductions in time to results and improvements in infection control measures, and had high diagnostic accuracy.
Trial Registration: This study is registered ISRCTN:14966673 and has completed.
Funding: University Hospitals Southampton NHS Foundation Trust
Declaration of Interests: TWC has received speaker fees, honoraria, travel reimbursement, and equipment and consumables free of charge for the purposes of research outside of this submitted study, from BioFire diagnostics LLC and BioMerieux. TWC has received consultancy fees from Synairgen research Ltd, Randox laboratories Ltd and Cidara therapeutics. He a member of an advisory board for Roche and a member of two independent data monitoring committees for trials sponsored by Roche. He has acted as the UK chief investigator for an IMP study sponsored by Janssen. All other authors have completed the Unified Competing Interest form (available on request from the corresponding author) and declare: no support from any organisation for the submitted work no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work.
Ethics Approval Statement: The study was approved by the South Central - Hampshire A Research Ethics Committee: REC reference 20/SC/0138, on the 16th March 2020.
Keywords: COVID-19, SARS-COV-2, Point-of-care testing, hospital, infection control, accuracy
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