Clinical trial NCT04699903: Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood
Official title: Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 IgG Antibody Test in Fingerstick Whole Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-Cov-2, Covid19
Keywords: IgG
Point of care testing
EUA
Lead sponsor: Lumos Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Rapid Pathogen Screening
First posted: 2021-01-07
Enrollment: 201
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the outpatient setting with EUA PCR test results who meet inclusion and exclusion criteria are eligible for the study.

Brief summary: Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.

Detailed description: Patients with PCR testing in outpatient setting will be screened and asked to participate in the study.

Subjects with a positive diagnosis of COVID-19 confirmed by a positive, EUA SARS-CoV-2 PCR test will be stratified by the number of days since first symptom onset (i.e. 0-7, 8-14, or \>15 days) in the positive cohort Subjects with a negative diagnosis of COVID-19 confirmed by a negative, EUA SARS-CoV-2 PCR test within 0-7 days of PCR sample collection will be included in the negative cohort.

Treating clinicians, clinical research coordinators and study subjects will be blinded to the POC test results.

Quality assurance will be assured with site monitoring to check accuracy and completeness of data entered.

Eligibility criteria: Positive Cohort

Inclusion Criteria:

* Patients with high-sensitive EUA PCR results (positive result)
* Previous diagnostic of SARS-Cov-2
* Signed informed consent

Exclusion Criteria:

* Missing PCR results
* Results from a non-high-sensitive PCR test

Negative Cohort

Inclusion Criteria:

* Patients with high-sensitive EUA PCR results (negative result)
* Signed informed consent

Exclusion Criteria:

* Missing PCR results
* Results from a non-high-sensitive PCR test
* Previous diagnostic of SARS-Cov-2
* History of a positive SARS-CoV-2 antibody test (IgG, IgM or Total Antibody)
* Negative SARS-Cov-2 PCR result that occurred \> 7 days from study visit

Primary outcomes:
measure: PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR
timeFrame: 0-7 days
measure: PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
timeFrame: 8-14 days
measure: PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR
timeFrame: 15 - 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Colton
country: United States
facility: Benchmark - SoCal
state: California
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Research
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials (GLCT)
state: Illinois
Study officials:
References: