Sekisui Diagnostics OSOM™ Ultra Strep A Test Kit

Description

• CLIA Complexity: Waived
• CPT Code: 87880QW
• Sensitivity: 96% (Ultra Sensitive—studies have shown the sensitivity of Ultra Strep A and the standard single swab culture are not statistically different)
• Specificity: 100%
• Dual Label Technology (DLT)™ uses antibody labeled color particles coated at two separate locations which allows for greater sensitivity than the conventional single label technology without sacrificing specificity
• Easy-to-read two-color results
• Results in five minutes
• Specimen Type: Throat swab
• Controls included in kit
• Performance Characteristics: tested by using Rigorous Gold Standard (multiple sample swab culture plus broth enhanced pledget culture) as the Gold Standard
• Reagents: Single reagent delivery system. Extraction reagents are combined into one device (25 test kit). No mixing or handling two different reagent bottles

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