COVID 19, Influenza a, Influenza B, RSV
Conditions
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.
Interventions
DIAGNOSTIC_TESTLIAISON NES FLU A/B, RSV & COVID-19
The 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.
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
* 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).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
Primary ContactJanet Farhang
Outcome results
None listed