A true one-step test and is the first Strep A test waived under CLIA "88. The unique in-line extraction and rapid procedure allow testing to take place at the point of care. Two-color results give you clear readability, and the proven accuracy of the QuickVue In-Line Strep A test provides dependable results in 5 minutes or less and 96% overall agreement with SBA culture. Individually packaged for convenient single-use testing and disposal. Positive and negative external controls included in the kit.