RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-30
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06672692

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * 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.
  3. * The specimen is from a human patient with active signs and symptoms of respiratory tract infection at time of collection
  4. * 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.
  5. * 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
  6. * The specimen was received in good condition (no leakage or drying of the specimen).
  1. * Incorrect swab type
  2. * Incorrect transport media
  3. * Incorrect specimen handling (e.g. specimens not stored at recommended temperature)
  4. * The specimen has undergone more than two freeze/thaw cycles
  5. * Specimens collected with calcium alginate or organic swabs

Contacts and Locations

Study Contact

Janet Farhang
CONTACT
5124015472
janet.farhang@diasorin.com

Study Locations (Sites)

PAS Research - Henderson
Henderson, Nevada, 89014
United States
PAS Research - Pittsburgh
Pittsburgh, Pennsylvania, 15227
United States
PAS Research - McAllen
McAllen, Texas, 78504
United States

Collaborators and Investigators

Sponsor: DiaSorin Molecular LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30
Study Completion Date2025-05

Study Record Updates

Study Start Date2024-09-30
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

  • Influenza a
  • Influenza B
  • RSV
  • COVID 19