Preview Rapid Strep A Test Method Comparison Study

NCT03907449 | Suspended FDA Device

• 1 other identifier: MDC_2018_Wondfo
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 2

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.

Conditions

Strep Throat

Outcome Measures

Primary Outcomes (1)

• Accuracy of Preview Strep A Rapid Test

  Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A

  3 months

Study Arms (1)

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

Interventions

Preview Rapid Strep A test DIAGNOSTIC_TEST

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

Symptoms of Strep Throat

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Currently taking antibiotics
• Previously enrolled in this study

Sponsors & Collaborators

• Guangzhou Wondfo Biotech Co., Ltd: lead

Study Sites (2)

UHSH Microbiology

Johnson City, New York, 13790, United States

Location

Summerwood Pediatrics

Liverpool, New York, 13088, United States

Location

Study Officials

• Paul Granato, PhD

  UHSH Microbiology

  PRINCIPAL INVESTIGATOR

• Jagmohan Sidhu, MD

  UHSH Microbiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: March 19, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)