What this study is
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.
What's being tested
- LIAISON NES FLU A/B, RSV & COVID-19
Intervention · DIAGNOSTIC TEST
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.
Study details
- Sponsor
- DiaSorin Molecular LLC
- Conditions
- Influenza a · Influenza B · RSV · COVID 19
- Enrolling
- 1,000 people
- Starts
- 2024-09-30
- Est. completion
- 2025-05
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- 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).
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for every open site
- Janet VP of Clinical Affairs · Contact5124015472janet.farhang@diasorin.com
PAS Research - Henderson
Henderson, Nevada, United States
RecruitingPAS Research - Pittsburgh
Pittsburgh, Pennsylvania, United States
RecruitingPAS Research - McAllen
McAllen, Texas, United States
Recruiting
Study team
Sponsor
DiaSorin Molecular LLC
Study ID DSM-PROT-005198
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.