Clinical performance of the BD Respiratory Viral Panel – SCV2 for BD MAX™ system with nasopharyngeal and anterior nasal specimens

The detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) relies heavily on highly sensitive and specific assays. While nasopharyngeal (NP) specimens are considered the gold standard, it is crucial that current assays also support the use of anterior nasal swab (NS) specimens, as they can be more suitable in situations where NP specimen collection is difficult or impractical. Paired NP and NS specimens prospectively collected from symptomatic and asymptomatic participants were utilized to evaluate the BD Respiratory Viral Panel - SCV2 for BD MAX™ System (BD RVP SCV2) clinical performance against a composite comparator of three CE-marked assays: cobas® SARS-CoV-2, Aptima® SARS-CoV-2, and Lyra® SARS-CoV-2. Concordance between at least two assays established a positive or negative comparator result. Each specimen was divided into four aliquots, one for each assay. BD RVP SCV2 performance was assessed by comparing results from NP specimens (NP vs NP), NS specimens (NS vs NS), and NS results with paired NP comparator results (NS vs NP). Positive and negative percent agreements (PPA and NPA) were calculated for all comparisons. Combined symptomatic and asymptomatic specimens, when tested with the BD RVP SCV2 assay, met all set acceptance criteria, with PPAs of 98.7 % (NP vs NP), 98.4 % (NS vs NS), and 92.6 % (NS vs NP) while NPAs ranged from 97.7 % to 98.0 %. These findings confirm that the BD Respiratory Viral Panel - SCV2 for BD MAX System performs well for detecting SARS-CoV-2 in NP and NS specimens from symptomatic and asymptomatic populations.