COVID-19 Molecular OTC At Home Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2023-04-30

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.

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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.

Conditions

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COVID-19 Pandemic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Diagnostic Test: IN Vitro

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Diagnostic Test: IN Vitro

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

Participants must not meet ANY of the following:

1. Eating or drinking 30 minutes prior, or smoking 60 minutes prior to specimen collection.
2. Unable to tolerate sample collection, or has contraindications to collection such as nasal bleeding, ulcers, or surgery within the past 3 months.
3. Underwent a nasal wash / aspirate as part of standard of care \< 24 hours prior to the study start.
4. Currently receiving or has received within the past 30 days of the study visit an experimental drug, biologic, or device including treatment or therapy.
5. Previously participated in this study.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes