Aptima SARS-CoV-2 Assay

The Aptima SARS-CoV-2 Assay is a nucleic acid amplification test designed to qualitatively detect RNA from SARS-CoV-2 in nasopharyngeal and anterior nasal swab specimens from patients with signs and symptoms of COVID-19. It runs on the fully automated Panther/Panther Fusion system and is intended as an aid in COVID-19 diagnosis when used alongside clinical and laboratory findings.

The Aptima assay uses Transcription-Mediated Amplification (TMA) technology with Dual Kinetic Assay (DKA) detection, employing target capture with magnetic microparticles and acridinium ester-labeled probes measured by luminometry. The predicate BioFire COVID-19 Test 2 uses reverse transcriptase multiplexed PCR on the BioFire FilmArray platform. Both are automated NAAT platforms detecting SARS-CoV-2; the main differences are the amplification method (TMA vs. RT-PCR) and platform hardware, with Aptima taking approximately 2.5 hours versus BioFire's 45 minutes.

Not stated in this summary.

Substantial equivalence is based on comparable clinical performance and analytical characteristics despite technological differences. Both devices target the same organism (SARS-CoV-2) in the same specimen types (respiratory swabs) for the same intended use (COVID-19 diagnosis in symptomatic individuals) using prescription-only, professional-use automated amplification platforms. Clinical studies demonstrated Aptima achieved 95.4% positive percent agreement and 99.5% negative percent agreement with a composite comparator algorithm on nasopharyngeal specimens, and 96.5–100% PPA and 97.6–98.0% NPA on anterior nasal specimens, demonstrating performance comparability to predicate devices and established reference methods.