Nano-Check™ Influenza A+B Test

Description

The Nano-Check™ Influenza A+B Test is a lateral flow immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B nucleoprotein antigens directly from anterior nasal swab (ANS) samples from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections. The test is not intended for the detection of influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A and B were established during the 2022-2025 influenza seasons when influenza A/H1N1pdm09, influenza A/H3N2, and influenza B/Victoria lineage were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary. If infection with a novel influenza 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 the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.