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The LIAISON NES FLU A/B, RSV & COVID-19 assay is a real-time RT-PCR assay intended for use on the LIAISON NES instrument for the simultaneous in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A) virus, influenza B (Flu B) virus, and respiratory syncytial virus (RSV) in anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B, and RSV can be similar.

The LIAISON NES FLU A/B, RSV & COVID-19 assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, influenza B, and RSV infections when used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A, influenza B, and RSV viral RNA are generally detectable in anterior nasal swab specimens during the acute phase of infection. This test is not intended to detect influenza C virus infections.

Positive results are indicative of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent(s) detected by the LIAISON NES FLU A/B, RSV & COVID-19 assay may not be the definite cause of the disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B or RSV infection and should not be used as the sole basis for patient management decisions.

The LIAISON NES Instrument (NES1001) is capable of analysis of a single cartridge containing a single specimen. A set of parameters specific to the assay is included in the instrument software to name target molecules, assign dyes to probes, specify cycling conditions, and to analyze data from runs. Fluorescence intensity is monitored at each PCR cycle by detection modules within the instrument. The instrument software controls the thermocycling and, upon completion of the run, automatically interprets and displays results for the specimen.

The LIAISON NES Instrument is comprised of the following:

• Touchscreen User Interface
• Status LED Indicator
• Audio Speaker
• Barcode Scanner

The LIAISON NES software is a graphical user interface (GUI) application that is the end-user interface to the LIAISON NES Instrument. The software is installed in an embedded computer. The LIAISON NES software is responsible for providing the environment in which a user runs assays and obtains results.

The LIAISON NES instrument is intended to accept a cartridge, containing either a quality control (QC) or patient sample, to process and detect for the target nucleic acid.

The LIAISON NES FLU A/B, RSV & COVID-19 assay used on the LIAISON NES instrument is a real-time RT-PCR system that enables the direct amplification, detection, and differentiation of influenza A viral RNA, influenza B viral RNA, RSV RNA, and SARS-CoV-2 RNA directly from nasal swabs. Nasal swabs can be professionally collected by a healthcare provider or self-collected under the healthcare provider's supervision.

The LIAISON NES FLU A/B, RSV & COVID-19 assay consists of the LIAISON NES instrument, the LIAISON NES FLU A/B, RSV & COVID-19 Cartridge containing all the required PCR reagents, the NES Sample Vial containing sample release buffer, and the NES Swab for sample collection.

In the LIAISON NES FLU A/B, RSV & COVID-19 assay, fluorescent probes are used with corresponding forward and reverse primers to amplify influenza A, influenza B, RSV, and SARS-CoV-2, and internal control (IC) RNA. Conserved regions of influenza A viral RNA, influenza B viral RNA, RSV RNA, and SARS-CoV-2 RNA are targeted to identify the viruses in the specimen, while the internal control (IC) RNA is used to detect any PCR failures and/or inhibition.

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