P327: Using Real-World Data in Claim Expansion of a Direct Molecular Test for Detecting SARS-CoV-2 in Asymptomatic Individuals
Poster Presenter
Baiyu Yang
Director of Epidemiology
Gilead Sciences United States
Objectives
This study aimed to leverage real-world data (RWD) to support claim expansion of a direct molecular test for detecting SARS-CoV-2 in asymptomatic individuals, by demonstrating the clinical use and performance of this test in the asymptomatic population during a global public health emergency.
Method
We leveraged RWD from the 2020 National Football League (NFL) COVID-19 Surveillance Program. Nasal samples were prospectively collected on a near-daily basis from players and staff. Positive/negative percent agreements (PPA/NPA) between candidate test result and comparator status were calculated.
Results
Between August 1, 2020-January 3, 2021, 1,776 samples were selected for analysis where the candidate test result and comparator status were both evaluable. For each of these samples, there was an additional sample tested with another molecular device. The comparator status was determined by an algorithm based on molecular comparator test results and/or clinical adjudication performed within the NFL program. All 11 samples with a positive comparator status were positive on the candidate test, leading to a PPA of 100% (95% Wilson Score Confidence Interval [CI]: 74.1%, 100%). Of 1,765 samples with a negative comparator status, 1,762 were negative on the candidate test, leading to a NPA of 99.8% (95% Wilson Score CI: 99.5%-99.9%). The results were consistent when stratified by age and sex, demonstrating the generalizability of these findings.
Conclusion
Based on RWD collected as part of an occupational testing protocol, this study demonstrated that the clinical performance of this molecular test for SARS-CoV-2 was adequate for the routine diagnostic setting to proactively test asymptomatic individuals, allowing timely public health interventions. This RWD study was complemented by data from an existing clinical study, which became available through a partnership with the agency. The findings from both studies collectively provided the ‘totality-of-evidence’ that supported FDA clearance for the expanded claim of this test for the qualitative detection of SARS-CoV-2 in the asymptomatic population.
