Coronavirus Disease 2019, Influenza A, Influenza Type B
Conditions
Brief summary
The DiaSorin Molecular LIAISON® NES FLU A/B & 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 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 & COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B and SARS-CoV-2 infection in a professional laboratory setting. Negative results do not preclude influenza A, influenza B, 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.
Interventions
DIAGNOSTIC_TESTLIAISON NES FLU A/B & COVID-19
The LIAISON® NES FLU A/B & 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 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.
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 * 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 * Subjects not consented
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | Samples will be tested on LIAISON NES within one hour 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. |
Countries
Australia
Outcome results
None listed