Trial Outcomes & Findings for Evaluation of Point-of-Care (EPOC) for COVID-19 (NCT NCT05227404)

NCT ID: NCT05227404

Last Updated: 2024-12-06

Results Overview

LumiraDx test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.

• Recruitment status: COMPLETED
• Target enrollment: 330 participants
• Primary outcome timeframe: an average of 1 day
• Results posted on: 2024-12-06

Participant Flow

Participant milestones

Measure	COVID19 Assays All participants enrolled will receive 2 point of care assays, and 1 central lab assay LumiraDX: Point-of-care test for SARS-CoV-2 RightSign: Point-of-care test for SARS-CoV-2 Case Control: Genscript assay performed on the plasma sample
Overall Study STARTED	330
Overall Study COMPLETED	330
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Point-of-Care (EPOC) for COVID-19

Baseline characteristics by cohort

Measure	COVID19 Assays n=330 Participants All participants enrolled will receive 2 point of care assays, and 1 central lab assay LumiraDX: Point-of-care test for SARS-CoV-2 RightSign: Point-of-care test for SARS-CoV-2 Case Control: Genscript assay performed on the plasma sample
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	148 Participants n=5 Participants
Age, Categorical >=65 years	182 Participants n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants
Sex: Female, Male Male	177 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	21 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	62 Participants n=5 Participants
Race (NIH/OMB) White	221 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: an average of 1 day

LumiraDx test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.

Outcome measures

Measure	COVID19 Assays n=330 Participants All participants enrolled will receive 2 point of care assays, and 1 central lab assay LumiraDX: Point-of-care test for SARS-CoV-2 RightSign: Point-of-care test for SARS-CoV-2 Case Control: Genscript assay performed on the plasma sample
Test Results Comparison Between LumiraDx and GenScript	0.097 Unitless Interval 0.059 to 0.135

PRIMARY outcome

Timeframe: an average of 1 day

RightSign test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.

Outcome measures

Measure	COVID19 Assays n=330 Participants All participants enrolled will receive 2 point of care assays, and 1 central lab assay LumiraDX: Point-of-care test for SARS-CoV-2 RightSign: Point-of-care test for SARS-CoV-2 Case Control: Genscript assay performed on the plasma sample
Comparison of Results Obtained by RightSign and GenScript	-0.038 Unitless Interval -0.074 to -0.001

SECONDARY outcome

Timeframe: an average of 1 day

The frequency with which the LumiraDx test fails to give an unambiguous result

Outcome measures

Measure	COVID19 Assays n=330 Participants All participants enrolled will receive 2 point of care assays, and 1 central lab assay LumiraDX: Point-of-care test for SARS-CoV-2 RightSign: Point-of-care test for SARS-CoV-2 Case Control: Genscript assay performed on the plasma sample
LumiraDx Valid Test Frequency	263 Participants

SECONDARY outcome

Timeframe: an average of 1 day

The frequency with wich the RightSign test fails to give an unambiguous result

Outcome measures

Measure	COVID19 Assays n=330 Participants All participants enrolled will receive 2 point of care assays, and 1 central lab assay LumiraDX: Point-of-care test for SARS-CoV-2 RightSign: Point-of-care test for SARS-CoV-2 Case Control: Genscript assay performed on the plasma sample
RightSign Valid Test Frequency	327 Participants

Adverse Events

COVID19 Assays

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eileen Denning

University of Minnesota

Phone: 612-626-8049

Email: edenning@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place