Clinical Evaluation of SARS-COV-2 (COVID-19), Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics

Launched by AUSDIAGNOSTICS PTY LTD. · Jul 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new test called the Highplex System, which is designed to quickly detect COVID-19, influenza, and respiratory syncytial virus (RSV) from samples taken from patients. The goal is to see how well this new test works compared to an existing test called the BioFire Respiratory Panel 2.1. This study is important because it aims to improve the way we diagnose respiratory viral infections, which can help doctors provide better treatment for patients with these illnesses.

To participate in this trial, individuals must be able to give consent or have a legal guardian who can do so on their behalf. Participants will need to provide a nasopharyngeal swab, which is a sample taken from the back of the nose and throat, and it must be collected using specific FDA-approved materials. The study will include people who have influenza-like symptoms, such as cough, sore throat, or fever, as well as those who may not show symptoms but are suspected of having a viral infection. It's also important to note that this trial is not yet recruiting participants, so there will be no immediate opportunities to join at this time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The sample is derived from an individual who has the ability to provide consent or from a legally acceptable representative, parent(s), or legal guardian and have consented for their sample and demographic information to be taken
• • The sample is a nasopharyngeal swab
• • The sample is collected in universal transport media (UTM) or viral transport media (VTM), using FDA approved swabs
• • The sample is collected from an individual who has a presumptive diagnosis or is presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea, sore throat, fever, headache, myalgia) or is suspected to be asymptomatic.
• Exclusion Criteria:
• • Sample does not meet acceptable specimen criteria in that is not a nasopharyngeal swab
• • The sample is collected using swabs with wood shafts or other materials known to inhibit growth of influenza viruses