Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection

Launched by EDAN INSTRUMENTS INC. · Dec 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two types of test kits designed to detect respiratory infections, including COVID-19, influenza A, influenza B, and respiratory syncytial virus (RSV). The goal is to see how well these test kits work in identifying these viruses when samples are taken from the nose or throat of people who show symptoms of respiratory illness, such as fever, sore throat, or nasal congestion. To assess their performance, the new tests will be compared to a standard device that is already approved for use.

To participate in the trial, individuals must have symptoms of a respiratory infection and be able to provide samples from their nose and throat. They also need to be willing to give consent for themselves or, if applicable, their legal guardians must provide consent. It's important to note that pregnant or breastfeeding women, as well as those who have recently had certain procedures involving nasal swabs, will not be eligible. Participants can expect to have their samples tested using both the new and the standard devices within a short time frame, helping researchers better understand how effective the new tests are.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects must meet ALL the inclusion criteria described below to be eligible for this clinical performance study.
• • 1. Subjects with suspected respiratory infection who have physical signs/symptoms, such as chills, fever, headache, myalgia, fatigue, nasal congestion, sore throat, and other symptoms.
• • 2. Subjects able to provide anterior nasal swabs and oropharyngeal swabs for testing on the study device according to the instructions for use of that device.
• • 3. Subjects able to provide comparator samples according to the instructions for use of the comparator device.
• • 4. Subjects able to provide study and comparator samples within 24 hours to allow for a valid comparison.
• • 5. Subjects or their legal guardians willing and able to provide written informed consent.
• Exclusion Criteria:
• • Subjects who meet any of the exclusion criteria described below will NOT be eligible for this clinical performance study.
• • 1. Subjects who have undergone anterior nasal, or oropharyngeal sampling within the past 30 minutes (i.e. a minimum wait of 30 minutes is required before collecting swabs for the study device if previous anterior nasal or oropharyngeal samples were collected from the same subject).
• • 2. Subjects or their legal guardians unwilling and unable to provide informed consent.
• • 3. Subjects who have had a nasal wash or aspirate procedure within the past 24 hours.
• • 4. Women who are pregnant or currently breastfeeding.