COVID-19
Conditions
Keywords
COVID-19, Sample Collection, Human Factors Study, Nasal Swab
Brief summary
The primary objective is to determine the usability of the SARS-CoV-2 Specimen Collection Materials for at-home collection and mailing of sample to the testing laboratory.
Detailed description
This study is a prospective observational human factors usability study designed to evaluate the Instructions For Use (IFU) in the SARS-CoV-2 Specimen Collection Materials based on the successful completion of self-collection of a nasal swab sample, which includes a valid SARS-CoV-2 test result.
Interventions
DIAGNOSTIC_TESTSARS-CoV-2
Determine usability of study materials and kit
Sponsors
Exact Sciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide informed consent
Exclusion criteria
* Prior medical or laboratory training * Prior experience with COVID-19 specimen self-collection * Prior SARS-CoV-2 testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Valid SARS-CoV-2 Test | Subjects are assessed at enrollment | The percent of samples from the fully enrolled cohort to return a valid SARS-CoV-2 test result (positive, not detected, or inconclusive) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Volunteers Men and women who had no prior medical or laboratory training, no prior experience with COVID-19 self-collection, or no prior SARS-CoV-2 testing. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Volunteers |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Level of Education College degree, or higher | 23 Participants |
| Level of Education Other level of education | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Valid SARS-CoV-2 Test
The percent of samples from the fully enrolled cohort to return a valid SARS-CoV-2 test result (positive, not detected, or inconclusive)
Time frame: Subjects are assessed at enrollment
Population: Each participant only completed one test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Volunteers | Valid SARS-CoV-2 Test | 30 Participants |