Rapid Strep A Antigen Test

The Healgen® Rapid Strep A Antigen Test is a rapid chromatographic immunoassay designed for the qualitative detection of Group A Streptococcal (Strep A) antigen from human throat swab specimens. It is intended to aid healthcare professionals in the diagnosis of Group A Streptococcal infection, providing easy-to-read results in just 5 minutes. Designed for convenient point-of-care testing, the Healgen Rapid Strep A Antigen Test combines a straightforward testing procedure with strong clinical performance. The test offers 96.5% sensitivity and 99.5% specificity, can be stored at room temperature, and has a 24-month shelf life from the date of manufacture. The U.S. GCSTR-501Ca configuration is FDA 510(k) cleared and CLIA Waived, comes in a 25-test kit, and includes external positive and negative controls. The kit contains the necessary testing components, making it a practical solution for physician offices, urgent care centers, clinics, and other eligible point-of-care testing environments. Key Product Features Results in 5 minutes 96.5% sensitivity 99.5% specificity Uses human throat swab specimens CLIA Waived (GCSTR-501Ca) FDA 510(k) cleared (GCSTR-501Ca) External positive and negative controls included 25 tests per kit 24-month shelf life Room-temperature storage