Preview Rapid Strep A Test Method Comparison Study

Wondfo Biotech

Status: Suspended

Conditions: Strep Throat

Treatments: Diagnostic Test: Preview Rapid Strep A test

Study type: Observational

Funder types: Industry

Identifiers

NCT03907449

MDC_2018_Wondfo

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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

Trial design

320 participants in 1 patient group

Symptoms of Strep Throat

Description:

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

Treatment:

Diagnostic Test: Preview Rapid Strep A test