In Vitro Diagnostic Device for the Detection of Strep A

Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02068469

Enrollment

799

Registered

2014-02-21

Start date

2013-12-31

Completion date

2014-04-30

Last updated

2016-08-31

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

Conditions

Streptococcal Sore Throat

Brief summary

The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects who are 3 years of age or older * Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including: * presence of sore throat, and at least one other symptom from the list below: * redness of the posterior pharyngeal wall * pharyngeal or tonsillar exudate * tonsillar swelling * tender cervical lymphadenopathy * fever, \>38C at presentation or within the past 24 hours * Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian

Exclusion criteria

* Subjects treated with antibiotics currently or within the previous 7 days.

Design outcomes

Primary

Measure	Time frame
Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture	Results based on samples collected at initial visit

Countries

United States

Outcome results