The DASH® 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 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 influenza A, and influenza B in humans in conjunction with other clinical, epidemiologic and laboratory findings and is not intended to detect Influenza C. Positive results of a specific target are indicative of the presence 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 influenza infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for Influenza A were established during the 2023-2024 influenza season when Influenza A/H3 and A/H1N1 pandemic were the predominant Influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL3+ facility is available to receive and culture specimens.
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