QUIDEL® QuickVue® Dipstick Strep A Test – 50 Test Kit
Rapid dipstick test for the detection of Group A Streptococcal antigen.
The QuickVue® Dipstick Strep A Test is a CLIA-waived rapid immunoassay that detects Group A Streptococcal antigen directly from patient throat swab specimens. Its dipstick format uses an off-line extraction process, making it simple and efficient for clinical staff. The test delivers two-color results for easy interpretation and offers high sensitivity even at low colony counts. The kit includes positive and negative external controls and is stored at room temperature.
Key Benefits
• Dipstick format with off-line extraction for easy handling
• Detects Group A Streptococcal antigen from throat swabs
• Two-color result for clear interpretation
• High sensitivity at low bacterial counts
• 95% overall agreement to throat culture
• CLIA-waived for use in point-of-care settings
• Includes positive and negative external controls
• Room temperature storage
Performance Characteristics
• Sensitivity: 92%
• Specificity: 98%
• Overall Agreement: 95%
Intended Use
For the rapid qualitative detection of Group A Streptococcal antigen from throat swab specimens to aid in the diagnosis of streptococcal pharyngitis.
Kit Contents
• 50 dipstick test devices
• Extraction reagents
• Sterile throat swabs
• Positive and negative control swabs
• Instructions for use
Packaging Details
• 50 tests per kit
• CLIA-waived classification
• For use with throat swab specimens only
• Room temperature storage (59–86°F)