Preview Rapid Strep A Test Method Comparison Study

Suspended

• Conditions: Strep Throat

• Registration Number: NCT03907449
• Lead Sponsor: Guangzhou Wondfo Biotech Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-19
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-06
• Last Update Posted: 2019-07-09
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Any patient presenting with symptoms of pharyngitis

  • Fever
  • Sore throat
  • Swollen lymph nodes in neck
  • Redness of throat/tonsils
  • White/yellow patches on tonsils
  • Not currently on antibiotics

• ≥3 years or older

• Ability to read, understand and sign a consent form, in English, or for parent(s) to sign an assent form providing permission to include children under the age of 18.

Exclusion Criteria

• Currently taking antibiotics
• Previously enrolled in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of Preview Strep A Rapid Test	3 months	Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A

Trial Locations

Locations (2)

UHSH Microbiology; 🇺🇸 Johnson City, New York, United States

Summerwood Pediatrics; 🇺🇸 Liverpool, New York, United States