A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDiaSorin Molecular LLC
About this trial
The DiaSorin Molecular LIAISON® NES FLU A/B, RSV \& COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B, RSV and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors.
The LIAISON® NES FLU A/B, RSV \& COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B, RSV and SARS-CoV-2 infection in a professional laboratory setting.
Negative results do not preclude influenza A, influenza B, RSV or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The specimen is a NPS or NS from a patient collected and preserved in 3 mL Universal Transport Media (UTM), BD Universal Viral Transport (UVT), or MicroTest M4RT transport media, or 1 mL Copan Eswab (Liquid Amies).
The specimen is from a patient who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
The specimen is from a human patient with active signs and symptoms of respiratory tract infection at time of collection
Specimen stored at 2-8°C for up to 72 hours from collection. If there is a delay in testing, store specimen at ≤-70 °C.
Disqualifiers
Incorrect swab type
Incorrect transport media
Incorrect specimen handling (e.g. specimens not stored at recommended temperature)
The specimen has undergone more than two freeze/thaw cycles
Trial design
Design model
Single group
Treatments tested in this trial
LIAISON NES FLU A/B, RSV & COVID-19
Diagnostic testThe LIAISON® NES FLU A/B, RSV \& COVID-19 assay used on the LIAISON® NES instrument is a real-time PCR system that enables the direct amplification, detection and differentiation of Flu A viral RNA, Flu B viral RNA RSV viral RNA, and SARS-CoV-2 RNA from dry nasal swabs. Nasal Swabs can be professionally collected by a Healthcare Provider or self-collected by the patient under the supervision of the healthcare provider. The collected nasal swab can then be directly loaded into the cartridge without nucleic acid extraction.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Blinded, Prospective ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy
Estimates of Sensitivity/percent positive agreement (PPA) and Specificity/percent negative agreement (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.
Time frame
Samples will be tested on LIAISON NES within two hours of collection.Secondary outcomes
1
Clinical Performance
The secondary objective is to compare the clinical performance of the LIAISON NES FLU A/B, RSV \& COVID-19 assay per clinical site, target patient sub-population (e.g. age group, patient location) and specimen collection method (e.g. professionally collected, patient self-collected).
Time frame
Samples will be tested on LIAISON NES within one hour of collection.Sponsors and contacts
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Source ClinicalTrials.gov