Status™ Strep A Strip

Immunoassay for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. Direct Group A Streptococcus Antigen Test Strip is a rapid immunochromatographic assay for the qualitative detection a group A streptococcal antigen directly from throat swab specimens. Product Specifications Tests/Box 30 Sample type Throat swab specimen collection Time to results 5-10 minutes Measures 96.2% Sensitivity / 98.7% Specificity Kit contents (30) test strips, (1) extraction reagent A, (1) extraction reagent B, (1) positive control, (1) negative control, (30) extraction tubes, (30) throat swabs, Instructions for use Storage 35-86°F (2-30°C) CLIA complexity Waived Certification FDA CPT Codes 87880QW More Information Instructions of Use (IFU) Healthcare Provider