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

Overview

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.

This study will be a multi-site, all-comers, clinical trial assessing the positive percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™ Rapid Self-Test, an investigational qualitative lateral flow immunoassay intended for non-prescription over-the-counter (OTC) use. Participants who are aged 2 years and older and meet the eligibility criteria will be enrolled for testing on the COVID/Flu Detect™ Rapid Self-Test and for comparator testing on (1) an FDA-cleared or emergency use authorized (EUA) SARS-CoV-2 RT-PCR test, (2) an FDA-cleared influenza A RT-PCR test, and (3) an FDA-cleared influenza B RT-PCR test. After obtaining informed consent, participants' age, sex, days post-symptom onset, signs and symptoms of respiratory illness, comorbidities, any medications taken or administered, influenza/COVID-19 vaccination history, race/ethnicity, socioeconomic status, and educational background will be collected. Next, two (2) anterior nasal swab samples will be collected from each participant, with at least a 15-minute normalization period between swab sample collections. One (1) of the nasal swab samples will be collected by a healthcare provider (HCP) from the participant. This nasal swab sample will be sent for comparator testing. The other nasal swab sample will be self-collected or collected by the participant's parent or legal guardian. Adults (participants aged 18 years or older) and older children (participants aged 14-17 years) will self-collect a nasal swab sample by swabbing both nostrils and will test the swab sample themselves on the COVID/Flu Detect™ Rapid Self-Test. For child participants aged 2-13 years, parents or legal guardians will collect a nasal swab sample from their child by swabbing both nostrils and will test the swab sample on behalf of their child on the COVID/Flu Detect™ Rapid Self-Test. The order of collection of the two nasal swab samples will be randomized. A third nasal swab sample may be collected by the participant or the participant's parent, if the first COVID/Flu Detect™ Rapid Self-Test result is invalid. Study staff will observe participants while they self-collect their nasal swab sample and perform the COVID/Flu Detect™ Rapid Self-Test, but participants will not be given any assistance or guidance on these procedures by the study staff.