415. Clinical Impact of Molecular Point-of-Care Testing for COVID-19 in Adults Presenting to Hospital: A Prospective, Interventional, Non-Randomised, Controlled Study

Abstract Background The management of the COVID-19 pandemic is hampered by the long delays associated with laboratory PCR testing. In hospitals this leads to poor patient flow and nosocomial transmission and so rapid, accurate diagnostic tests are urgently required. The aim of this study was to evaluate the clinical impact and real-world diagnostic accuracy of molecular point-of-care testing (mPOCT) for COVID-19 in hospital. Methods We performed a prospective, interventional, non-randomised, controlled study of mPOCT for COVID-19 in adults presenting to hospital with suspected COVID-19. Patients were tested using the QIAstat-Dx SARS-CoV-2 at the point-of-care with results delivered to clinical and infection control teams. Control patients were tested using the PHE Rdrp reference assay. The Primary outcome measure was time to result and secondary outcome measures included infection control outcomes and measures of diagnostic accuracy. Results Between 20th March and 29th April 2020 500 patients were tested by POCT and 555 controls, who were tested with laboratory PCR, were identified. Overall 33% were positive for SARS-CoV-2. Median 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 time to arrival in definitive clinical area (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, p< 0.0001. Median time to enrolment into other COVID-19 clinical trials was 1.5 (1 to 3) days in the POCT versus 3.0 (2 to 5) days in the control group, p< 0.0001. Sensitivity of the POCT was 99.4% and specificity was 98.3%. The sensitivity of the laboratory PHE reference RdRp assay was 87.2% and specificity was 98.9%. Conclusion mPOCT was associated with a large reduction in time to results and improvements in infection control measures and patient flow, compared with laboratory PCR. In addition, patients were recruited onto other clinical trials more rapidly with POCT. The QIAstat-Dx SARS-CoV-2 panel had high diagnostic accuracy for the detection of COVID-19 compared to laboratory PCR. Resources should be urgently made available to support the widespread implementation of mPOCT in hospitals, in preparation for the second wave. Disclosures Tristan William. Clark, BM MRCP DTM&H MD, BioFire Diagnostics (Other Financial or Material Support, Equiptment and consumables for the purposes of research)BioMerieux (Other Financial or Material Support, Equipment and consumables for the purposes of research)Qiagen (Other Financial or Material Support, Discounted Equipment and consumables for the purposes of research)