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

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. MethodsWe 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.

COVID-19 Point-of-Care Diagnostics That Satisfy Global Target Product Profiles

“…A proposed solution for ending the lockdown is the large-scale utilization of rapid point-of-care diagnostic tests (POCTs) into the current COVID-19 testing, tracking, and tracing strategy. Such strategies can help mitigate the impact of the pandemic on vulnerable populations while allowing for society and the economy to continue to function [ 3 , 4 ].…”

“…However, RT-PCR usually requires expensive equipment and reagents that have limited its application to centralized laboratories with highly trained laboratory personnel, and typically a turnaround time of one to several days from specimen collection to the issuance of a result. The management of COVID-19 infection can be severely hindered by such long turnaround times [ 4 ]. Furthermore, expanding laboratory-based PCR testing capacity is beyond the financial means of many low- and middle-income countries and its logistics make it less agile to use as a near-patient or community-based test.…”

Diagnostic accuracy and utility of SARS-CoV-2 antigen lateral flow assays in medical admissions with possible COVID-19

“…Even using rapid platforms, SARS-CoV-2 RT-PCR turnaround times are often too slow to inform patient placement from emergency departments (EDs). 4 SARS-CoV-2 LFAs could help improve flow of patients from the ED into ‘COVID-19 positive’ cohorts and reduce pressure on limited hospital isolation rooms. However, little data exists on their diagnostic accuracy in this setting.…”

Implementing rapid diagnostics for COVID-19

“…We congratulate Nathan Brendish and colleagues for doing their trial during the first COVID-19 wave. 1 The reduction in turnaround time in the point-of-care testing group was impressive, especially considering 6 months later more than 10% of patients in English hospitals still have to wait more than 24 h for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR test results. 2 We agree that rapid diagnostics offer numerous benefits, but a substantial challenge remains in optimal implementation.…”

“…Disappointingly, no differences in clinical outcomes were seen between the point-of-care testing group and the control group. 1 Although more treatments are now available, patients most likely to benefit from COVID-19-specific treatments are those with more severe disease and therefore also likely to be treated empirically.…”