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Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC

NCT05514691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2022-08-24

No results posted yet for this study

Summary

A rapid point of care test for the detection of virus particles will be compared to the FDA approved EUA RT-PCR detection standard. The iStatis COVID-19 Ag Rapid Test is intended for rapid point-of-care detection of the SARS-CoV-2 nucleocapsid protein antigen.

Conditions

Interventions

DIAGNOSTIC_TEST

iStatis COVID-19 Ag Rapid Test

SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test

DIAGNOSTIC_TEST

"COVID-19 RT-PCR Test EUA Number: EUA200011, Company: Laboratory Corporation of America ("Labcorp")

The Labcorp COVID-19 RT-PCR or EURORealTime SARS-Cov-2 tests are performed on all appropriate swab samples from each subject enrolled as a comparator test to iStatis Rapid Test

Sponsors & Collaborators

  • bioLytical Laboratories

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2022-01-21
Completion
2022-01-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05514691 on ClinicalTrials.gov