Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus

Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus Aureus Nasal Colonization: Comparative Analysis to Culture Screening Methods

To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.

Inclusion Criteria:

1. Subjects 18 years of age or older, male or female and from any race or culture.
2. Subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for non-emergent surgery.

Exclusion Criteria:

1. Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks.
2. Subjects who are present at the preoperative visit with prescribed nasal medical devices (e.g. CPAP = Continuous Positive Airway Pressure or Nasal Cannula), nasal prosthetics, the wearing of nasal jewelry or trauma to the nose or anything that may inhibit sampling of the anterior nares.