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NCT04699903 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Lumos Diagnostics.

Completed
Registry status
201
Enrollment target

NCT04699903: Completed study, sponsored by Lumos Diagnostics.

NCT04699903 is a clinical trial that has completed, run by Lumos Diagnostics. The registered enrollment target is 201 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04699903 has completed, sponsored by Lumos Diagnostics.

COMPLETED
Registry status
201 participants
Enrollment target

Study 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.

Primary Outcome

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)

Interventions

  • DIAGNOSTIC_TEST POC SARS-Cov-2 IgG Antibody test

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2021-01-05
Est. Completion 2021-04-09
Lumos Diagnostics

6 total trials

What the finished NCT04699903 record still lists

NCT04699903 is an observational study that tracks outcomes without assigning an intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which POC SARS-Cov-2 IgG Antibody test is the first listed.

NCT04699903 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04699903 about?

NCT04699903 is a clinical study titled "Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood". 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.

What is the current status of trial NCT04699903?

This trial is currently completed. The enrollment target is 201 participants. The study started on 2021-01-05. Estimated completion is 2021-04-09.

What interventions are being tested in trial NCT04699903?

The interventions under investigation include: POC SARS-Cov-2 IgG Antibody test (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04699903?

This trial is sponsored by Lumos Diagnostics, which has 6 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04699903, the US trial registry maintained by the National Library of Medicine. NCT04699903 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.