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

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.

Recruiting

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Key information

Conditions

Influenza A COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza B Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections RSV Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PAS Research - Henderson, Henderson, Nevada, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

Diagnostic Accuracy

Time frame: Samples will be tested on LIAISON NES within two hours of collection.

Estimates of Sensitivity/percent positive agreement (PPA) and Specificity/percent negative agreement (NPA) will be calculated based on a two-by-two table (comparator method result vs. result from LIAISON® NES FLU A/B, RSV & COVID-19 assay or LIAISON PLEX® RSP Flex assay) for each target. In addition, 95% two-sided confidence intervals will be provided. A separate Sensitivity/PPA and Specificity/NPA for each target, to include those specimens excluded due to a discrepancy between the standard-of-care and molecular comparator result, will be presented in a separate 2 x 2 table.

Secondary outcomes

Clinical Performance

Time frame: Samples will be tested on LIAISON NES within one hour of collection.

The secondary objective is to compare the clinical performance of the LIAISON NES FLU A/B, RSV & COVID-19 assay per clinical site, target patient sub-population (e.g. age group, patient location) and specimen collection method (e.g. professionally collected, patient self-collected).

Study contacts

Contact information is provided by the study sponsor or research team.

Janet Farhang

CONTACT

[email protected]

5124015472

Sponsors and collaborators

Lead sponsor

DiaSorin Molecular LLC

Industry

Registry information

Acronym: NES ABCR

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 4, 2024
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed