NCT05553964

SARS-CoV-2 OTC At Home Test

Prospective, Multi-Center, Non-Randomized Study to Evaluate the 3EO Health SARS-CoV-2 Molecular Diagnostic Test

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: 3EO Health · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19 Pandemic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	In Vitro	In vitro diagnostic test for COVID-19 using anterior nasal swabs.

Timeline

• Start date: 2022-10-07
• Primary completion: 2022-11-18
• Completion: 2022-11-18
• First posted: 2022-09-26
• Last updated: 2022-12-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study