Prospective Clinical Evaluation of COVID/Flu Detect™ Rapid Self-Test in Symptomatic Subjects for Non-Prescription Over-the-Counter (OTC) Use

ID#: NCT06734741

Age: 2 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: December 26, 2024

End Date: May 01, 2025

Contact Information:
Marketa Hnilova
206-326-5415
Allison Bardagjy
206-344-5821
Summary: The goal of this study is to evaluate the performance of the COVID/Flu Detect™ Rapid Self-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ Rapid Self-Test is an investigational device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasal swab samples. Participants who are aged two (2) years and older and have symptoms of respiratory illness consistent with SARS-CoV-2 and influenza infection may be enrolled. Participants will use the COVID/Flu Detect™ Rapid Self-Test to self-collect, self-test, and interpret the results. Participants will have a nasal swab sample collected by a healthcare provider for comparator testing by PCR tests for SARS-CoV-2, influenza A, and influenza B. Researchers will compare the results of the COVID/Flu Detect™ Rapid Self-Test obtained by the participants to results from the PCR comparator tests to evaluate performance.
Eligibility:

Inclusion Criteria:

- Subjects must be at least 18 years of age, or at least 2 years of age and accompanied by parent or legal guardian.

- Subjects must be willing and able to give informed consent or assent (as age-appropriate).

- Subjects must be able to read/speak English (or Spanish at specific sites) if subject is an adult, minor aged 14 years or older, or parent/guardian of a child subject aged 2 through 13 years.

- Subjects must be currently exhibiting at least two of the following symptoms consistent with possible SARS-CoV-2 or influenza infection: fever or feeling feverish (in absence of documented fever), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or runny nose, nausea or vomiting, and/or diarrhea. Subjects must be within 5 days of symptoms onset at enrollment (the day that symptoms start is day 0).

Exclusion Criteria:

- Subject was previously enrolled in this study.

- Subject has undergone a nasal wash or nasal aspirate procedure on day of enrollment.

- Subject has an active nosebleed.

- Subject has received results of an influenza or COVID-19 test within the previous 5 days.
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