Description
Clarity-Strep-A-Strip-test-Package-Insert
Unit: 1 Box
Regulatory Status: CLIA Waived
Contents: (25) Test Strips, (25) Disposable Extraction Tubes, (25) Sterile Throat Swabs, Reagents A and B, Positive and Negative Controls, Workstation, Package Insert, and Procedure Card
Determinations: Streptococcus A
Test Strip Storage Requirements: 39° F – 86° F (Refrigeration Not Required)
Collection Method: Throat Swab
Clarity Step A Strip Foil Pack, CLIA Waived, 25/bx
The Clarity Strep A Rapid Test is a chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens from symptomatic patients to aid in the diagnosis of Group A Streptococcal Infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for use in physician’s offices, hospitals, and clinical laboratories.
For in vitro diagnostic use only
For prescription use only
- Sensitivity of 95%
- Specificity of 98.4%
- Fast and easy test results in 5 minutes or less
- Room temperature storage
- CLIA Waived
- 24 month dating
- Internal and external controls included in each kit
- Available in individually pouched strips or vials
