Preview Rapid Strep A Test Method Comparison Study

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.

Study Overview

• Status: Suspended
• Conditions: Strep Throat
• Intervention / Treatment: Diagnostic test: Preview Rapid Strep A test

• Study Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

Study Locations

• United States
  • New York
    • Johnson City, New York, United States, 13790
      • UHSH Microbiology
    • Liverpool, New York, United States, 13088
      • Summerwood Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Approximately 320 patients to be tested, expecting 50-100 positive for Strep A collected from patients of any age and gender from two CLIA waived or waivable sites. Children will be enrolled in this study due to the high prevalence of Strep A infections in minors and the intention to market this investigational device for use for all ages following FDA clearance.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptoms of Strep Throat; 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	Diagnostic test: Preview Rapid Strep A test; Rapid assay for the detection of type A streptococcal infection of the throat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Preview Strep A Rapid Test	Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A	3 months

Collaborators and Investigators

• Sponsor: Guangzhou Wondfo Biotech Co., Ltd
• Investigators: Principal Investigator: Paul Granato, PhD, UHSH Microbiology; Principal Investigator: Jagmohan Sidhu, MD, UHSH Microbiology

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 6, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections
• Other Study ID Numbers: MDC_2018_Wondfo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No