Preview Rapid Strep A Test Method Comparison Study

Guangzhou Wondfo Biotech Co., Ltd320 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

320

Conditions

Strep Throat

Interventions

Preview Rapid Strep A testDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

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

Locations (2)

UHSH Microbiology

Johnson City, New York, United States

Summerwood Pediatrics

Liverpool, New York, United States

Outcomes

Primary Outcomes

Accuracy of Preview Strep A Rapid Test

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

Time frame: 3 months

Data from ClinicalTrials.gov

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