Recruiting

LIAISON NES

Sponsor:

DiaSorin Molecular LLC

Code:

NCT06672692

Conditions

Influenza a

Influenza B

RSV

COVID 19

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Influenza a

Influenza B

RSV

COVID 19

Study ID

NCT06672692

Start date

Sep 30, 2024

Status verified date

Nov, 2024

Completion date

May, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Blinded, Prospective Arm

Clinical specimens shall be collected prospectively from patients with signs or symptoms of respiratory tract infection. Nasal swab in Copan universal transport media (UTM) 3 milliliters for comparator testing should be collected by a healthcare professional.

Where subjects are willing and able, up to 40% of nasal swab for the investigational device will be self-collected under the guidance and supervision of a healthcare professional.

Nasopharyngeal (NPS) specimens (optional) should only be collected by a healthcare professional. All specimens collected from children 13 years or younger should only be collected by a trained healthcare professional. Follow the Centers for Disease Control and Prevention guidelines for collecting NPS swabs, unless otherwise specified by the sponsor.

Interventions

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.

Primary outcome measure

  • Diagnostic Accuracy [ Time Frame: Samples will be tested on LIAISON NES within two hours of collection. ]

Central Contacts and Locations

Central contacts

Janet Farhang

5124015472janet.farhang@diasorin.com

Locations

PAS Research - Henderson

Recruiting

Henderson, Nevada, United States, 89014

Contacts

Janet VP of Clinical Affairs

5124015472janet.farhang@diasorin.com

PAS Research - Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15227

Contacts

Janet VP of Clinical Affairs

5124015472janet.farhang@diasorin.com

PAS Research - McAllen

Recruiting

McAllen, Texas, United States, 78504

Contacts

Janet VP of Clinical Affairs

5124015472janet.farhang@diasorin.com

More Information

Sponsor

DiaSorin Molecular LLC

Last update posted

Nov 4, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by DiaSorin Molecular LLC on 2024-11-04.