Analytical and Clinical Comparison of Three Nucleic Acid Amplification Tests for SARS-CoV-2 Detection
Elizabeth Smith, Wei Zhen, Ryhana Manji, Deborah Schron, Scott Duong, Gregory J. Berry
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first identified in December 2019 and has quickly become a worldwide pandemic. In response, many diagnostic manufacturers have developed molecular assays for SARS-CoV-2 under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) pathway. This study compared three of these assays, the Hologic Panther Fusion SARS-CoV-2 assay (Fusion), the Hologic Aptima SARS-CoV-2 assay (Aptima), and the BioFire Defense COVID-19 test (BioFire), to determine analytical and clinical performance as well as workflow.
Topics & Concepts
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Food and drug administrationCoronavirus disease 2019 (COVID-19)Nucleic Acid Amplification TestsVirology2019-20 coronavirus outbreakCoronavirusAuthorizationPandemicMedicinePharmacologyOutbreakInternal medicineComputer scienceInfectious disease (medical specialty)DiseaseChlamydia trachomatisComputer securitySARS-CoV-2 detection and testingSARS-CoV-2 and COVID-19 ResearchBiosensors and Analytical Detection