CLIA Complexity: Waived CPT Codes: 87880/87880QW One-step lateral flow immunoassay for the detection of Group A streptococcal antigen from throat swab specimens Results within 5 minutes Sensitivity: 92% Specificity: 99% Overall accuracy: 96% Ideal for exam room environments Built-in procedural controls confirm proper test performance Two-color read-out makes results easy to interpret For in vitro diagnostic use