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

Launched by DIASORIN MOLECULAR LLC · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the LIAISON® NES FLU A/B, RSV & COVID-19 assay. This test is designed to quickly detect and differentiate between four respiratory viruses: influenza A, influenza B, respiratory syncytial virus (RSV), and COVID-19. It will be used on patients who are showing symptoms of a respiratory infection, like a cough or fever, to help doctors make the right diagnosis in a laboratory setting. The goal is to ensure that patients receive the appropriate care based on which virus they may have.

To participate in this trial, patients need to have a nasal swab taken while they are experiencing active symptoms of a respiratory infection. Eligible patients include those who are hospitalized, visiting an emergency department, attending an outpatient clinic, or living in a long-term care facility. Participants can expect their nasal swab samples to be tested and analyzed for these viruses, but it's important to remember that a negative result does not completely rule out an infection. Lastly, the trial is currently recruiting patients of all ages and genders, provided their samples meet specific criteria for quality and handling.

Gender

ALL

Eligibility 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