Trial Outcomes & Findings for Home Usability Study of the SARS-CoV-2 (COVID-19) Test (NCT NCT04395391)

Last Updated: 2023-12-13

Results Overview

The percent of samples from the fully enrolled cohort to return a valid SARS-CoV-2 test result (positive, not detected, or inconclusive)

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

Subjects are assessed at enrollment

Results posted on

2023-12-13

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Home Usability Study of the SARS-CoV-2 (COVID-19) Test

Baseline characteristics by cohort
Measure	Volunteers n=30 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Level of Education College degree, or higher	23 Participants n=5 Participants
Level of Education Other level of education	7 Participants n=5 Participants

Timeframe: Subjects are assessed at enrollment

Population: Each participant only completed one test.

The percent of samples from the fully enrolled cohort to return a valid SARS-CoV-2 test result (positive, not detected, or inconclusive)

Outcome measures
Measure	Volunteers n=30 Participants 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.
Valid SARS-CoV-2 Test	30 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Exact Sciences

Phone: 608-284-5700

Principal investigator is a sponsor employee Principal Investigator agreed that they shall not, without the Sponsor's prior written consent, independently publish, publicly disclose, present or discuss any results of or information pertaining to the activities conducted under their agreement for a period of one (1) year following completion of the Study.
Publication restrictions are in place

Restriction type: OTHER