COVID-19 Molecular OTC At Home Test

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Multi-Center, Non-Randomized Study to Evaluate OTC At Home SARS-CoV-2 Molecular Diagnostic Test

Conditions
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COVID-19 Pandemic

Intervention / Treatment
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* Diagnostic Test: Diagnostic Test: IN Vitro


Participation Criteria
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Eligibility Criteria
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All Participants must meet ALL of the following: ≥ 2 years of age. Subjects ages 2 ≤ x ≤ 17 will provide assent in addition to parent / legal guardian's consent. Able to read and write in English and/or Spanish (subjects or guardians) Willing and able to provide informed consent (subject or Legally authorized Representative (LAR)). Subjects unable to consent will provide assent in addition to LAR consent. Symptomatic Participants must meet BOTH of the following: Have at least one of the following symptoms the day of the test: Fever Cough Shortness of Breath Difficulty Breathing Muscle Pain Headache Sore Throat Chills New loss of taste or smell Congestion Runny nose Onset of symptoms occurred within the past 7 calendar days. Asymptomatic Participants must meet BOTH of the following: Not experiencing any of the following symptoms at the time of specimen collection and testing: fever, cough, shortness of breath or difficulty breathing, new loss of taste or smell, muscle or body aches, headache, sore throat, congestion or runny nose, nausea or vomiting or diarrhea. Exposed to known COVID-19 positive individuals or are suspected to have had COVID-19 over the past 7 calendar days. Exclusion Criteria: Participants must not meet ANY of the following: Eating or drinking 30 minutes prior, or smoking 60 minutes prior to specimen collection. Unable to tolerate sample collection, or has contraindications to collection such as nasal bleeding, ulcers, or surgery within the past 3 months. Underwent a nasal wash / aspirate as part of standard of care < 24 hours prior to the study start. Currently receiving or has received within the past 30 days of the study visit an experimental drug, biologic, or device including treatment or therapy. Previously participated in this study.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Groups<br>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<br>* In vitro diagnostic test for COVID-19 using anterior nasal swabs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample. | The primary endpoints of this study will be the correlation of the 3EO Health SARS-CoV-2 OTC At Home Test results from nasal samples to the comparator, standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample | 1-16 weeks |