COVID-19 Pandemic
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTIn Vitro
In vitro diagnostic test for COVID-19 using anterior nasal swabs.
Sponsors
3EO Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the 3EO Health SARS-CoV-2 standard of care (PCR) Zymo rRT-PCR results of the anterior nare sample. | 1-16 weeks | 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. |
Countries
United States
Outcome results
None listed