In Vitro Diagnostic Device for the Detection of Strep A

IQuum

Status: Completed

Conditions: Streptococcal Sore Throat

Study type: Observational

Funder types: Industry

Identifiers

NCT02068469

SASA 4.0

Details and patient eligibility

About

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.

Enrollment: 799 patients

Sex: All

Ages: 3+ years old

Volunteers: No 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.