DASH® SARS-CoV-2 & Flu A/B Test

The DASH SARS-CoV-2 & Flu A/B Test is a rapid RT-PCR assay performed on the DASH Rapid PCR Instrument for simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus RNA in anterior nasal swab specimens from patients with signs and symptoms of respiratory tract infection. The test aids in differential diagnosis in conjunction with clinical, epidemiologic, and laboratory findings.

Both the subject device and predicate use RT-PCR amplification for nucleic acid detection with magnetic bead purification technology and qualitative reporting. The key difference is that DASH uses a single reaction chamber with a four-channel LED fluorometer, whereas the predicate (BioFire SPOTFIRE) uses an array/spot format. Both devices include automated test processes, internal controls, and separately sold external controls, with approximately 15-minute result times.

IEC 60601-1-2 Ed. 4.1:2020 (electromagnetic disturbances), IEC 61010-1 3rd edition (safety), IEC 61010-2-010:2019 (heating of materials), IEC 61010-2-101:2018 (in vitro diagnostic equipment), CLSI EP12 3rd Edition (qualitative test performance), CLSI MM03-3rd Edition (molecular diagnostic methods), CLSI EP07 3rd Edition (interference testing), CLSI EP25 2nd Edition (reagent stability).

Both devices are classified under the same regulation (21 CFR 866.3981) and product code (QOF) with the same intended use population and clinical application. The subject device demonstrates comparable analytical performance through sensitivity/specificity testing with 95.2%-97.3% positive percent agreement and 98.1%-99.5% negative percent agreement against FDA-cleared comparator tests. Analytical validation including inclusivity, cross-reactivity, and interference testing shows the single-chamber design performs equivalently to the predicate's array format. Clinical performance across seven sites with 795 evaluable subjects confirms the device functions as intended without raising new safety or effectiveness concerns.