A-378 Clinical Evaluation and Implementation of Rapid COVID-19 Antigen Test in Qatar

Abstract Background In March, the World Health Organization (WHO) declared COVID-19 as a global public health emergency. To curb the spread of virus, timely detection of infected patients and screening of suspected cases in massive population posed a challenge for the healthcare system. Rapid antigen tests (RAT) were high in demand as a fast, accurate and cost-effective screening tool to increasing the testing capacity. In this crucial timing, clinical evaluation and procurement of available COVID-19 RAT following the World Health Organization (WHO) guidelines was a huge challenge for Point of Care testing (POCT) department. The aim of this study is to highlight the challenges overcame in establishing a Point-of-care COVID-19 testing system including personnel training and building a compatible Laboratory Information System (LIS) upholding Hamad Medical Corporation (HMC) cyber security regulation. Methods Three regulatory approved RATs were evaluated against real-time polymerase chain reaction (RT-PCR) and analytical performance were verified. Maintaining the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologist (CAP) standards for COVID-19 waived testing, POCT team initiated to conduct practical and educational training vastly through online platforms and face to face sessions. We utilized the extendable LIS functionality for fast medical decisions in hospitals and enabled “reason of testing” feature in Qatar's COVID-19 tracking application. Results Our performance verification showed 98.0% sensitivity and 100% specificity for PanbioTM COVID-19 RAT, 98.0% sensitivity and 100% specificity for Quidel SOFIA2 COVID-19 RAT and Roche COVID-19 RAT yielded a sensitivity of 97.0% and specificity of 100%. Total of 291 training sessions were conducted for 9710 clinical staffs across 17 HMC facilities and 185 private clinics. Using LIS and POC middleware features, obvious increment in RAT of more than 509 tests per day has been reported in a single emergency unit. Overall, 5.5% decrement in incorrect patient identification data using QUIDEL SOFIA2 automated device and LIS functions was recorded in laboratory quality indicator data. COVID-19 tracking application was linked to antigen results for contact tracing, isolating, and breaking the chain of transmission. Conclusion The methods established for the COVID-19 implementation showed acceptable performance fulfilling the elements of HMC product procurement specification and CAP Accreditation standards. Synergic actions of HMC-POCT with supportive laboratory management aided prompt decision making to optimize patient management and added efficiency to the public health control measures in Qatar.