LIAISON PLEX Respiratory Flex Assay

The LIAISON PLEX Respiratory Flex (RSP Flex) Assay is a multiplexed qualitative test for the simultaneous in vitro

detection and identification of multiple bacterial and viral nucleic acids in nasopharyngeal swabs (NPS) obtained from

individuals with clinical signs and symptoms of respiratory tract infection, including SARS-CoV-2. The test is performed

on the automated LIAISON PLEX System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and

array hybridization to detect specific nucleic acid gene sequences of the following organism types and subtypes:

Viruses:

Adenovirus

Human Coronavirus (HKU1, NL63, OC43, and 229E not differentiated)

Human Enterovirus/Rhinovirus (not differentiated)

Human Metapneumovirus,

Influenza A

Influenza A (subtype H1)

Influenza A (subtype H3)

Influenza B

Parainfluenza 1

Parainfluenza 2

Parainfluenza 3

Parainfluenza 4

Respiratory Syncytial Virus

Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2)

Bacteria:

Bordetella holmesii

Bordetella parapertussis

Bordetella pertussis

Chlamydia pneumoniae

Mycoplasma pneumoniae

Nucleic acids from the bacterial and viral organisms identified by this test are generally detectable in NPS specimens

during the acute phase of infection. Detecting and identifying specific bacterial and viral nucleic acids from individuals

exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction

with other clinical, epidemiological, and laboratory findings. The results of this test should not be used as the sole basis

for diagnosis, treatment, or patient management decisions.

Negative results in the presence of a respiratory illness may be due to infection with pathogens that are not detected by

this test or due to lower respiratory tract infection that is not detected by an NPS specimen. Conversely, positive results do

not rule out infection or co-infection with organisms not detected by the LIAISON PLEX Respiratory Flex (RSP Flex)

Assay. The agent(s) detected may not be the definite cause of disease.

The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography), may be

necessary when evaluating a patient with possible respiratory tract infection.