To establish the relative accuracy of the LIAISON® NES Flu A/B, RSV & COVID-19 assay forviral nucleic acid targets from professionally collected or patient self-collected drynasal (NS) swabs and to establish the relative accuracy of the LIAISON PLEX® RSP Flexassay from NS and nasopharyngeal swabs (NPS) in applicable transport media from humanpatients exhibiting clinical signs and symptoms of a respiratory tract infection.
This study is a clinical evaluation of two investigational devices on the same patient
specimens:
- The LIAISON® NES FLU A/B, RSV & COVID-19 assay used for the detection and
identification of influenza A, influenza B, RSV and SARS-CoV-2 on the LIAISON® NES
system, developed by DiaSorin Molecular
- The LIAISON PLEX® RSP Flex assay used for the detection and identification of 19
common respiratory pathogens, including 14 viral and 5 bacterial targets on the
LIAISON PLEX® system, developed by Luminex Corporation (a subsidiary of DiaSorin)
This study will utilize untrained operators to perform investigational device testing on
the LIAISON NES platform, and as such instrument or assay-specific training will not be
provided beforehand. Sites will receive the necessary protocols and instructions for use
required to implement the study protocol. Testing on the LIAISON PLEX® platform will be
performed by trained operators. Study staff will receive training on the device prior to
the start of testing. The diagnostic accuracy of the LIAISON® NES FLU A/B, RSV & COVID-19
assay will be evaluated using dry NS specimens prospectively collected from patients who
meet the study inclusion criteria. The diagnostic accuracy of the LIAISON PLEX® RSP Flex
assay will be evaluated using NS and NPS specimens prospectively collected from patients
who meet the study inclusion criteria and stored in the applicable transport media.
Performance of the LIAISON® NES FLU A/B, RSV & COVID-19 and LIAISON PLEX® RSP Flex assays
will be compared to one or more US FDA-cleared molecular assays, or as required by the
local regulatory body.
Approximately 600-1000 prospective specimens will be tested using the LIAISON® NES FLU
A/B, RSV & COVID-19 and LIAISON PLEX® RSP Flex assays, with a goal to obtain
approximately 50 comparator method confirmed positives per target for influenza A and
SARS CoV-2 and 30 comparator method confirmed positives per target for influenza B and
RSV. The study is estimated to be conducted for approximately 3 months and should cover
the length of the flu season, as appropriate.
Diagnostic Test: LIAISON NES FLU A/B, RSV, & COVID-19
The LIAISON® NES FLU A/B, RSV & COVID-19 real-time (RT) PCR assay is a Point of Care
(POC) system that enables the extraction, amplification, detection and differentiation of
influenza A, Influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2 viral RNA from
dry nasal swabs (NS). The system consists of the LIAISON® NES FLU A/B, RSV & COVID-19
cartridge, the LIAISON® NES system (with LIAISON® NES Software), and associated
accessories. In the LIAISON® NES FLU A/B, RSV & COVID-19 cartridge, extraction reagents
and lyophilized fluorescent probes are used together with corresponding forward and
reverse primers to extract and amplify influenza A, influenza B, RSV, SARS-CoV-2 and
internal control RNA targets.
Diagnostic Test: LIAISON PLEX Respiratory Flex Assay
The LIAISON PLEX® (also known as VERIGENE® II) RSP Flex Assay is an automated test for
the detection and identification of common viruses and bacteria, including severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA, from upper respiratory specimens.
The VERIGENE® II Respiratory Flex (RSP Flex) Assay is performed on the VERIGENE® II
System. The VERIGENE® II System is an automated platform that performs sample preparation
and is capable of polymerase chain reaction (PCR) for the detection of target-specific
nucleic acids. The VERIGENE® II System is a fully automated, bench-top "sample-to-answer"
device. The test reagents are supplied in a single, disposable test cartridge.
Other Name: VERIGENE II
Inclusion Criteria:
- Human patients with active signs and symptoms of respiratory tract infection at time
of collection
- Specimens collected within 7 days of symptom onset for the initial collection
- Patient consents to participate in the study
- Availability of age, gender, race, ethnicity, collection dates, collection time,
routine respiratory testing method, routine respiratory result, signs and symptoms
(e.g., fever), date of symptom onset for each symptom, vaccination status (Flu and
COVID-19, as applicable), pre-existing medical conditions (as applicable),
medications (e.g., COVID-19 antivirals), etc. for each subject
Exclusion Criteria:
- Incorrect swab type
- Incorrect transport media
- Incorrect specimen handling (specimens not stored at recommended temperature)
- Samples collected >7 days from symptom onset
- Subject does not provide informed consent or subject withdraws informed consent
Key Health - Bondi
Bondi Junction, New South Wales, Australia
Key Health - CBD South
Sydney, New South Wales, Australia
Key Health - Pagewood
Sydney, New South Wales, Australia
Maxwell Medical Group
Melbourne, Victoria, Australia
Rachel Behounek, PhD
512-336-3554
rbehounek@luminexcorp.com
Janet Farhang, PhD, Principal Investigator
DiaSorin Molecular/Luminex Corporation