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The VELO Respiratory Test is an automated rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test performed on the VELO Instrument and is intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B virus nucleic acid in anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar.

The VELO Respiratory Test is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A and influenza B viral nucleic acid are generally detectable in ANS specimens during the acute phase of infection.

Positive results do not rule out co-infection with other organisms. The agent(s) detected by the VELO Respiratory Test may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

The VELO System is comprised of a single-use VELO Respiratory Test, and a reusable VELO Instrument:

• The Test contains individually packaged consumables: a "Test Cartridge" and an anterior nasal swab.
• The Instrument is a small, benchtop device with preloaded software for running tests and viewing the results. For a full description of the VELO Instrument, please refer to the VELO Instrument Manual.

Each Test Cartridge contains all necessary reagents for the detection of Flu A, Flu B and SARS-CoV-2 viral RNA from anterior nasal swab specimens. Primers and probes in the VELO Respiratory Test are designed to amplify and detect unique sequences within the following regions of each target pathogen: influenza A genome (matrix protein gene), influenza B genome (non-structural protein gene), and SARS-CoV-2 genome (ORF 1a/b non-structural region, and membrane protein gene). Each Test Cartridge also contains an endogenous Sample and Process Control (SPC). The SPC acts as an Internal Control (IC), to control for adequate sample collection and processing, the detection of failures in the reaction resulting from PCR inhibition, or a failure of the reagents. The SPC also ensures that the RT-PCR reaction conditions (temperature and time) are appropriate for the amplification reaction and that the resulting signal can be detected and processed by the system. Test outcomes are reported to the operator in real-time via the Instrument viewscreen with 'Not Detected' results available in under 10 minutes, when all cycles have completed. When the Test ends, all results can be viewed via the Instrument viewscreen, and the Test Cartridge may be removed for disposal.

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