NCT05704803

COVID-19 Molecular OTC At Home Test

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: 3EO Health · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• COVID-19 Pandemic

Interventions

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

Timeline

• Start date: 2022-04-11
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2023-01-30
• Last updated: 2023-09-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study