A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
- Conditions
- Influenza aInfluenza BRSVCOVID 19
- Registration Number
- NCT06672692
- Lead Sponsor
- DiaSorin Molecular LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- The total volume of the leftover specimen received is ≥1.5 mL, except for specimens collected in Liquid Amies which requires a total leftover volume of ≥0.5 mL
- The specimen was received in good condition (no leakage or drying of the specimen).
- 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
- Specimens collected with calcium alginate or organic swabs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Diagnostic Accuracy Samples will be tested on LIAISON NES within two hours of collection. 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.
- Secondary Outcome Measures
Name Time Method Clinical Performance Samples will be tested on LIAISON NES within one hour of collection. 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).
Trial Locations
- Locations (3)
PAS Research - Henderson
🇺🇸Henderson, Nevada, United States
PAS Research - Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
PAS Research - McAllen
🇺🇸McAllen, Texas, United States