SARS-CoV-2 OTC At Home Test

3EO Health64 enrolled

Overview

The objective of this study is to evaluate the 3EO Health COVID-19 Test in individuals presenting at a medical facility. In eligible subjects, nasal samples will be collected for use with the 3EO Health COVID-19 Test, which will be compared to the Zymo® rRT-PCR test results obtained via samples specified by the manufacturer (e.g., AN \[anterior nares\] swab) to determine accuracy of the 3EO Health COVID-19 Test in detecting COVID-19 in participants.

3EO Health, Inc. has developed the 3EO Health COVID-19 Test, a unique rapid molecular test system, to detect SARS-CoV-2 virus in the OTC setting using a dedicated test reader "3EO Cube" to test nasal swab samples. Early testing will help to determine limit of detection (LOD) of the 3EO Health COVID-19 Test and will be compared to a sensitive molecular test that has been authorized for emergency use by the FDA. The 3EO Health COVID-19 Test will leverage the processing and testing of the 3EO Health Swab device when inserted directly into the reaction tube (3EO 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 3EO Health Cube test reader.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

COVID-19 Pandemic

Interventions

In VitroDIAGNOSTIC_TEST

In vitro diagnostic test for COVID-19 using anterior nasal swabs.

Eligibility

Sex: ALLMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Individuals suspected of COVID-19 disease by a healthcare provider or individuals who have tested positive within the past 7 calendar days with a confirmed positive COVID-19 test 2. Individuals able to self-administer the investigational test either upon themselves or upon their child (under sixteen (16) years of age) as a parent or guardian 3. Individuals willing and able to provide informed consent or obtain consent from legal authorized representative (LAR) Exclusion Criteria: 1. If symptomatic, individuals with self-declared symptoms greater than 7 days (plus/minus 1 day, if symptoms start not definite) 2. Unable to provide consent or obtain consent from a LAR 3. Unwilling or unable to collect all sample types 4. Enrolled in a study to evaluate an investigational drug 5. Eating/drinking/smoking 30 minutes prior to specimen collection 6. Prisoner or under incarceration 7. Have contraindications to the collection of nasal specimens from the nares/nostrils, such as but not limited to nasal ulcers or nasal surgery within 3 months prior to sample collection

Locations (5)

Sarkis Clinical Trials

Gainesville, Florida, United States

I.V.A.M. Clinical & Investigational Center

Miami, Florida, United States

Sunrise Research Institute

Sunrise, Florida, United States

Vytalus Medical Atascocita

Humble, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 1-16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.