3EO Health
The objective of this study is to evaluate the a molecular, OTC/At-Home COVID-19 Test in individuals presenting at a medical facility. In eligible subjects, nasal samples will be collected for use with the at-home molecular COVID-19 Test, which will be compared to the Zymo® rRT-PCR test results obtained via samples specified by the sponsor (e.g., AN [anterior nares] swab) to determine accuracy of the at-home/OTC molecular COVID-19 Test in detecting COVID-19 in participants.
COVID-19 Pandemic
Diagnostic Test: IN Vitro
Not Applicable
The molevular, at-home COVID-19 Test is a unique rapid molecular test system intended to detect SARS-CoV-2 virus in the OTC setting using a dedicated reusable test reader to test nasal swab samples. Early testing will help to determine limit of detection (LOD) of the molecular COVID-19 Test and will be compared to a sensitive molecular test that has been authorized for emergency use by the FDA. The COVID-19 Test will leverage the processing and testing of the associated Swab device when inserted directly into the reaction tube (Key) where reverse transcription, Loop-Mediated Isothermal DNA Amplifications (LAMP) processing and sequence-specific probe technologies to detect segments of the SARS-CoV-2 genome are managed automatically by the reusable test reader.}}
Study Type : | Interventional |
Estimated Enrollment : | 202 participants |
Masking : | None (Open Label) |
Primary Purpose : | Diagnostic |
Official Title : | Prospective, Multi-Center, Non-Randomized Study to Evaluate OTC At Home SARS-CoV-2 Molecular Diagnostic Test |
Actual Study Start Date : | April 11, 2022 |
Estimated Primary Completion Date : | April 30, 2023 |
Estimated Study Completion Date : | April 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Study Groups Positives: Symptomatic vs. Asymptomatic Negatives: Symptomatic vs. Asymptomatic Each broken down by age groups: 2-14 years old 15-24 years old 25-64 years old 65+ years old |
Diagnostic Test: Diagnostic Test: IN Vitro |
Ages Eligible for Study: | 2 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Bright Research Center
Miami, florida, United States, 33144
Not yet recruiting
I.V.A.M. Clinical & Investigational Center
Miami, florida, United States, 33144
Not yet recruiting
Vytalus Medical Atascocita
Humble, Texas, United States, 77346
Not yet recruiting
Vytalus Medical
Kingwood, Texas, United States, 77339