CLIA #
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This test is CLIA WAIVED for prescription, in vitro diagnostic use only.
Results in 5 minutes
The Rapid Response™ Strep A Detection Strip is a rapid test for the qualitative detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus, Strep A) antigen from throat swab specimens of symptomatic patients to aid in the diagnosis of Group A Streptococcus bacterial infection, providing results within 5 minutes.
Contents
- 25 Test Strips
- 25 Sterile Swabs
- 25 Disposable extraction tubes (One tube for each test strip)
- 1 Reagent A (10mL; 2M Sodium Nitrite)
- 1 Reagent B (10mL; 0.2M Acetic Acid)
- 1 Positive Control (1mL: Non-viable Strep A; 0.05% ProClin™ 300)
- 1 Negative Control (1mL: Non-viable Strep C; 0.05% ProClin™ 300)
- 2 Tube Holders
- 1 Instructions for Use
- 1 Quick Reference Instructions
Details
- Sample: Throat swab
- Format: Strip
- Time-to-Result: 5 minutes
- Storage Condition: 36-86°F/ 2-30°C
- Test Principle: Lateral Flow Assay
Performance Specifications
Sensitivity 96.5%, Specificity 99.5%
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