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-19pandemic is hampered by the long delays associated with centralised laboratoryPCR testing. In hospitals this leads to poor patient flow and nosocomial transmission.Rapid, accurate tests are therefore urgently needed in preparation for the nextwave. Methods We performed a prospective,interventional, non-randomised, controlled study of molecular point-of-caretesting (POCT) in adults presenting to hospital with suspected COVID-19. Interventiongroup patients were tested using the QIAstat-Dx Respiratory SARS-CoV-2 Panel atthe point-of-care and control patients were tested using laboratory PCR. The primaryoutcome was time to results. Secondary outcomes included infection control and diagnosticaccuracy measures. This study is registered ISRCTN:14966673 and has completed. Findings 499 patients were tested by POCT and555 control patients were tested using laboratory PCR. Median (IQR) time toresults with POCT was 1·7 (1·6 to 1·9) hours versus 21·3 (16·0 to 27·9) hours in the control group (differenceof 19·6 hours, 95%CI 19·0 to 20·3; p Interpretation POCT was associated with large reductionsin time to results and improvements in infection control measures, and had highdiagnostic accuracy, compared to laboratory PCR testing. Funding University Hospitals Southampton NHS Foundation Trust.