Preview Rapid Strep A Test Method Comparison Study

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03907449

Enrollment

320

Registered

2019-04-09

Start date

2019-03-19

Completion date

2020-05-31

Last updated

2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Strep Throat

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.

Interventions

DIAGNOSTIC_TESTPreview Rapid Strep A test

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026