Abstract
Respiratory diseases can share many of the same symptoms, highlighting the need for timely and accurate differentiation to facilitate effective clinical management and reduce transmission. Compared with centralized testing, molecular point-of-care tests (POCTs) can provide a faster time to result. We evaluated the RT-PCR POCT Cobas® SARS-CoV-2 & Influenza A/B qualitative assay for use on the Cobas Liat system (the POC SARS-CoV-2 & Influenza A/B test) in nasal and nasopharyngeal swab samples from 10 diverse healthcare facilities in the United States. A composite comparator design consisting of three centralized tests was used to analyze severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), while performance vs a single centralized test was used for analysis of influenza A and B. Evaluations included performance stratified by sample type (prospective/retrospective and nasal/nasopharyngeal [paired by subject]), collection method (self/healthcare worker-collected [alternated and approximately balanced]), symptom status (symptomatic/asymptomatic), and SARS-CoV-2 vaccination status, as well as assay inclusivity and system ease of use. A total of 2,247 samples were tested. For SARS-CoV-2, the overall percent agreement (OPA) was 98.8% (95% confidence interval [CI]: 97.9, 99.3) in nasal swab samples and 99.0% (95% CI: 98.2, 99.4) in nasopharyngeal swab samples. Regression analysis showed that cycle threshold values from paired nasal and nasopharyngeal swab samples were highly correlated (correlation coefficient 0.83). The OPA was ≥99.5% (sample type dependent) and 100.0% for influenza A and B, respectively. The POC SARS-CoV-2 & Influenza A/B test was easy to use. These results support the use of the POCT in various sample types and by various operators in the intended-use setting. IMPORTANCE: This study highlights the benefits of RT-PCR point-of-care tests, namely comparable performance to centralized testing in multiple sample types and ease of use. Utilizing assays such as the POC Cobas SARS-CoV-2 & Influenza A/B test may improve the timely differentiation of respiratory diseases that share similar symptoms.