Product Description
Genzyme Osom Ultra Strep A Test Kit, 25/bx
Immunochromatographic assay statistically equivalent to single swab culture.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.CLIA Complexity: Waived.