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

Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)

EPOC is designed to examine the feasibility of conducting two point-of-care (POC) tests the LumiraDx SARS-CoV-2 Antibody Test and the RightSign COVID-19 IgG/IgM Rapid Test for SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a central laboratory on specimens obtained from the same study participants at the same time.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS CoV 2 Infection
• Intervention / Treatment: Diagnostic test: LumiraDX; Diagnostic test: RightSign; Diagnostic test: Case Control

• Study Type: Observational
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adults hospitalized with COVID-19

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Informed consent by the patient or the patient's legally authorized representative (LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood samples.
• SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to consent OR documented by NAT or equivalent testing more than 3 days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator. (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained for TICO and that list will also be used for this protocol.)
• Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator.
• Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.

Exclusion Criteria:

• Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as part of this protocol.

• Disease severity beyond that of stratum 1 in the TICO trial. This includes the following conditions:

  1. stroke
  2. meningitis
  3. encephalitis
  4. myelitis
  5. myocardial infarction
  6. myocarditis
  7. pericarditis
  8. symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] class III-IV)
  9. arterial or deep venous thrombosis or pulmonary embolism

• Current requirement for any of the following:

  1. high-flow supplemental oxygen
  2. non-invasive ventilation
  3. invasive mechanical ventilation
  4. extracorporeal membrane oxygenation
  5. mechanical circulatory support
  6. vasopressor therapy
  7. commencement of renal replacement therapy at this admission (i.e., not patients on chronic renal replacement therapy).
• In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID19 Assays; All participants enrolled will receive 2 point of care assays, and 1 central lab assay	Diagnostic test: LumiraDX; Point-of-care test for SARS-CoV-2; Diagnostic test: RightSign; Point-of-care test for SARS-CoV-2; Diagnostic test: Case Control; Genscript assay performed on the plasma sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test Results Comparison Between LumiraDx and GenScript	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.	an average of 1 day
Comparison of Results Obtained by RightSign and GenScript	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.	an average of 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LumiraDx Valid Test Frequency	The frequency with which the LumiraDx test fails to give an unambiguous result	an average of 1 day
RightSign Valid Test Frequency	The frequency with wich the RightSign test fails to give an unambiguous result	an average of 1 day

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; SARS COV 2; COVID19 testing
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: STUDY00014758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No