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

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.

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.