Description
Rapid Detection: Delivers results in five minutes, enabling prompt diagnosis and treatment initiation for streptococcal infections.
CLIA Waived: CLIA waived status ensures ease of use and regulatory compliance, allowing for convenient testing in various healthcare settings.
Comprehensive Contents: Each box contains 50 dipsticks (2 vials of 25), disposable extraction test tubes, sterile swabs, reagent 1 (10 mL; 2M Sodium Nitrite), reagent 2 (10 mL; 0.2M Acetic Acid), positive control (1 mL; Non-viable Strep A; 0.09% NaN3), negative control (1 mL; Non-viable Strep C; 0.09% NaN3), instructional insert, and workstations, providing all necessary components for accurate testing.
High Sensitivity and Specificity: Offers 97% sensitivity and 95% specificity, ensuring reliable detection of Strep A antigen for accurate diagnosis.
Quality Controls: External positive and negative quality controls are provided for assurance of test accuracy and reliability.
For In Vitro Diagnostic Use: Intended for in vitro diagnostic use only, ensuring accurate and reliable results for clinical decision-making.
Long Shelf Life: With a 24-month shelf life, the test kits remain viable for extended periods, reducing the need for frequent restocking.
Not Made with Natural Rubber Latex: Manufactured without natural rubber latex, making it suitable for individuals with latex sensitivities or allergies.
Sample Type: Suitable for throat/tonsil saliva sample collection, providing convenience and ease of specimen collection.
Packaged for Convenience: Each box contains 50 tests, offering healthcare facilities and laboratories with a convenient and cost-effective testing solution.