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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 B in humans in conjunction with other clinical, epidemiologic and laboratory findings. Positive results of a specific target are indicative of that viral RNA and may not be the definite cause of disease. Positive results do not rule out co-infection with other pathogens. Negative results do not preclude SARS-COV-2, influenza A or influenza B infection and should not be used as the sole basis for patient management decisions.

The DASH® SARS-CoV-2 & Flu A/B Test is a rapid, polymerase chain reaction (PCR) assay performed on the DASH Rapid PCR Instrument (DASH Instrument) with the DASH External Controls. The external control materials and DASH Instrument are sold and distributed separately from the DASH SARS-CoV-2 & Flu A/B Test. The DASH SARS-CoV-2 & Flu A/B Test (for use with the DASH Rapid PCR System components) uses reverse transcription polymerase chain reaction (RT-PCR) for rapid qualitative detection and differentiation of SARS-CoV-2, Flu A and Flu B from nasal swabs. The test combines the technologies of sequence specific capture sample preparation and RT-PCR amplification. The DASH SARS-CoV-2 & Flu A/B Test cartridge contains all reagents necessary to perform the test. An anterior nares nasal swab with a 30-mm breakpoint is used to collect a specimen. The nasal swab specimen is added directly to the DASH SARS-CoV-2 & Fly A/B Test cartridge sample chamber. The cartridge is capped and inserted into the DASH Rapid PCR Instrument to initiate the test, and all subsequent test steps are performed automatically by the DASH Instrument.