The DiaSorin Molecular LIAISON® NES FLU A/B, RSV & COVID-19 real-time polymerase chainreaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument forthe 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 withsigns and symptoms during the acute phase of respiratory tract infection in conjunctionwith clinical and epidemiological risk factors.The LIAISON® NES FLU A/B, RSV & COVID-19 assay is intended for use as an aid in thedifferential diagnosis of influenza A, influenza B, RSV and SARS-CoV-2 infection in aprofessional laboratory setting.Negative results do not preclude influenza A, influenza B, RSV or SARS-CoV-2, infectionand should not be used as the sole basis for patient management decisions. The assay isnot intended to detect the presence of the influenza C virus.
Not Provided
Diagnostic Test: LIAISON 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.
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
PAS Research - Henderson
Henderson, Nevada, United States
PAS Research - Pittsburgh
Pittsburgh, Pennsylvania, United States
PAS Research - McAllen
McAllen, Texas, United States
Janet Farhang
5124015472
janet.farhang@diasorin.com
Not Provided