Status™ Strep A Plus

Rapid immunochromatographic assay for the 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. The test is intended for use in the physician's offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection. Product Specifications Tests/Box 50 Sample type Throat swab specimen collection Time to results 5-10 minutes Measures 96.2% Sensitivity / 98.7% Specificity Kit contents (50) test devices, (50) sterile throat swabs, (50) extraction tubes, Extraction reagent A, Extraction reagent B, (1) positive control, (1) negative control, Reaction tube rack, Instructions for use Storage 35-86°F (2-30°C) CLIA complexity Waived Certification FDA CPT Codes 87880QW More Information Instructions of Use (IFU) Heal