SEKISUI OSOM® Ultra Strep A Test – 25 Test Kit
Rapid test for the detection of Group A Streptococcal antigen with high sensitivity and fast results.
The OSOM® Ultra Strep A Test by Sekisui Diagnostics is a CLIA-waived lateral flow immunoassay that detects Group A Streptococcal antigen directly from throat swab specimens. With results in just 5 minutes and an easy-to-read two-color format, this test delivers the speed of a rapid diagnostic with accuracy comparable to standard culture. It’s ideal for urgent care, pediatric clinics, and physician offices needing fast, reliable results to guide treatment.
Key Benefits
• Detects Group A Streptococcus from throat swab specimens
• Results in 5 minutes or less
• Sensitivity comparable to single-swab culture
• Easy-to-read two-color result window
• CLIA-waived for point-of-care use
• Minimal hands-on time
• Room temperature storage
Performance Characteristics
• Sensitivity: 95%
• Specificity: 98%
• Overall Agreement: Comparable to traditional culture methods
• Time to Results: 5 minutes
Intended Use
For the rapid qualitative detection of Group A Streptococcal antigen from throat swab specimens to aid in the diagnosis of streptococcal pharyngitis.
Kit Contents
• 25 test devices
• Extraction reagents
• Sterile throat swabs
• Positive and negative controls
• Instructions for use
Packaging Details
• 25 tests per kit
• CLIA-waived classification
• For use with throat swab specimens
• Room temperature storage (59–86°F)