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A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients

DiaSorin Molecular LLC · NCT06672692

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
1000
US sites recruiting
3
Study start
September 30, 2024
Record last updated
November 4, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LIAISON NES FLU A/B, RSV & COVID-19

Conditions: Influenza a; Influenza B; RSV; COVID 19

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • PAS Research - Henderson

    Henderson, NV 89014

    Site contact: Janet VP of Clinical Affairs · 5124015472 · janet.farhang@diasorin.com

  • PAS Research - Pittsburgh

    Pittsburgh, PA 15227

    Site contact: Janet VP of Clinical Affairs · 5124015472 · janet.farhang@diasorin.com

  • PAS Research - McAllen

    McAllen, TX 78504

    Site contact: Janet VP of Clinical Affairs · 5124015472 · janet.farhang@diasorin.com

Study contacts (from the official record)

  • Janet Farhang · 5124015472 · janet.farhang@diasorin.com
A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV &… (NCT06672692) | Bored Studies