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This Trial is a Clinical Performance Validation Study That Will Evaluate the Clinical Agreement of the Sky Medical™ Rapid Antigen Test Comparing the Antigen Rapid Test to RT-PCR

NCT05491993 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-08-08

No results posted yet for this study

Summary

Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR.

Conditions

Interventions

DIAGNOSTIC_TEST

Sky Medical™ Rapid Antigen Test

Rapid Antigen Diagnostic Test device performance comparative to RT-PCR.

Sponsors & Collaborators

  • Sky Medical Supplies & Equipments, LLC

    lead INDUSTRY

Principal Investigators

  • Sri Madireddy, PhD

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2023-01-11
Completion
2023-01-11
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 NCT05491993 on ClinicalTrials.gov