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Preview Rapid Strep A Test Method Comparison Study

NCT03907449 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2019-07-09

No results posted yet for this study

Summary

This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.

Conditions

  • Strep Throat

Interventions

DIAGNOSTIC_TEST

Preview Rapid Strep A test

Rapid assay for the detection of type A streptococcal infection of the throat.

Sponsors & Collaborators

  • Guangzhou Wondfo Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Paul Granato, PhD · UHSH Microbiology

  • Jagmohan Sidhu, MD · UHSH Microbiology

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2020-05-31
Completion
2020-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03907449 on ClinicalTrials.gov