Using Real-World Data to Support Claim Expansion of the Cobas SARS-CoV-2 Test in Asymptomatic Testing: Data from the...

Clinical evidence is needed for performance of novel coronavirus disease (COVID-19) molecular tests in asymptomatic populations to support regulatory decisions. To support claim expansion of a direct molecular test, clinical use and performance of the Cobas^® SARS-CoV-2 qualitative test for use on Cobas 5800/6800/8800 Systems ("candidate test") for detecting SARS-CoV-2 in individuals who are asymptomatic were investigated.

This study leveraged real-world data from the 2020 National Football League (NFL) COVID-19 Surveillance Program during August 1, 2020-January 3, 2021. NFL players and staff from 32 clubs had nasal samples prospectively collected on a near-daily basis. Samples underwent reverse transcription polymerase chain reaction (RT-PCR) testing by a single provider across five laboratories. The study population included individuals whose samples were tested on the candidate test. A comparator algorithm was constructed based on comparator test results and clinical adjudication within the NFL program. Results from the candidate test were compared against the comparator algorithm to calculate positive and negative percent agreements (PPA and NPA). Two-sided 95% confidence intervals (CIs) for PPA and NPA were determined (Wilson score method).

A total of 1776 samples were included in the final analysis. All 11 samples with positive comparator status were positive on the candidate test (PPA 100% [95% CI 74.1, 100]). Of 1765 samples with negative comparator status, 1762 were negative on the candidate test (NPA 99.8% [95% CI 99.5, 99.9]). Results were consistent when stratified by age and sex.

Based on data collected during this occupational testing protocol, our study provides strong evidence supporting real-world performance of this test in an asymptomatic population. These findings, complemented by data from an existing clinical study, provided the totality-of-evidence that supported the US Food and Drug Administration clearance for the expanded claim of the candidate test for the qualitative detection of SARS-CoV-2 in the asymptomatic population.