Adenovirus, Bordetella Parapertussis Infection, Bordetella Pertussis Infection, Respiratory, Chlamydia Pneumonia, Coronavirus Disease 2019, Enterovirus, Influenza A, Influenza Type B, Mycoplasma Pneumonia, Para Influenza, Respiratory Syncytial Virus (RSV)
Conditions
Brief summary
To establish the relative accuracy of the LIAISON® NES Flu A/B, RSV & COVID-19 assay for viral nucleic acid targets from professionally collected or patient self-collected dry nasal (NS) swabs and to establish the relative accuracy of the LIAISON PLEX® RSP Flex assay from NS and nasopharyngeal swabs (NPS) in applicable transport media from human patients exhibiting clinical signs and symptoms of a respiratory tract infection.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTLIAISON 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_TESTLIAISON 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.
Sponsors
DiaSorin Molecular LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Participants are not provided investigational results and will only be provided with routine standard of care diagnostics results.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | Samples will be tested on LIAISON NES within one hour of collection. | Estimates of Sensitivity/PPA and Specificity/NPA will be calculated based on a two-by-two table (comparator method result vs. result from LIAISON® NES FLU A/B, RSV & COVID-19 assay or LIAISON PLEX® RSP Flex assay) for each target. In addition, 95% two-sided confidence intervals will be provided. A separate Sensitivity/PPA and Specificity/NPA for each target, to include those specimens excluded due to a discrepancy between the standard-of-care and molecular comparator result, will be presented in a separate 2 x 2 table. |
Countries
Australia
Contacts
Primary ContactRachel Behounek, PhD
Outcome results
None listed