Nuclein DASH® SARS-CoV-2 & Flu A/B Test

Description

The DASH SARS-CoV-2 & Flu A/B Test is a rapid reverse transcription polymerase chain reaction (RT-PCR) assay performed on the DASH Rapid PCR Instrument and is intended for the simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B virus ribonucleic acid (RNA) in anterior nasal swab specimens from patients with signs and symptoms of respiratory tract infection. The test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans in conjunction with other clinical, epidemiologic and laboratory findings.
Test Type: Rapid reverse transcription polymerase chain reaction (RT-PCR)
Specimen Type: Anterior nasal swab specimens
Turnaround Time: 15 minutes
CLIA Complexity: Waived
FDA Status: 510K granted