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

DiaSorin

Status: Enrolling

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

Treatments: Diagnostic Test: LIAISON NES FLU A/B, RSV & COVID-19

Study type: Interventional

Funder types: Industry

Identifiers

NCT06672692

DSM-PROT-005198

Details and patient eligibility

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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Blinded, Prospective Arm

Other group

Description:

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.

Treatment:

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