Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood

Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 IgG Antibody Test in Fingerstick Whole Blood

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04699903

Enrollment

201

Registered

2021-01-07

Start date

2021-01-05

Completion date

2021-04-09

Last updated

2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-Cov-2, Covid19

Keywords

IgG, Point of care testing, EUA

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.

Interventions

DIAGNOSTIC_TESTPOC SARS-Cov-2 IgG Antibody test

All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
PPA (positive percent agreement) and NPA (negative percent agreement) of POC compared to SARS-CoV-2 reference PCR	0-7 days	Determine PPA and NPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)
PPA (positive percent agreement) of POC compared to SARS-CoV-2 reference PCR	8-14 days	Determine PPA of point of care (POC) SARS-CoV-2 IgG antibody test compared to SARS-CoV-2 PCR with EUA (FDA emergency use authorization)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026