quidel
Dipstick Strep A
RespiratoryThe QuickVue Dipstick Strep A Test detects Group A Streptococcal antigen directly from patient throat swab specimens, or confirmation of presumptive Group A Streptococcal colonies recovered from culture and is used as an aid in the diagnosis of Group A Streptococcal infection.
INTENDED USE
The QuickVue Dipstick Strep A Test is intended for the rapid, qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies recovered from culture. The test is to be used to aid in the diagnosis of Group A Streptococcal infection. For use by healthcare professionals.
FEATURES & BENEFITS
| Feature | Benefit |
| Dipstick | Easy to use |
| Results in 5 minutes | Test and treat in the same office visit |
| Two reagents | Fewer steps, easy to perform, requires minimal training |
| Two-color result | Easy to read and interpret |
| Pictorial Procedure Card | Clear and simple illustrations to guide the rapid strep A test procedure |
| All components included in kit | Ready to use, no need for additional equipment |
| Internal controls included | Provides verification of test strip functional integrity, increasing confidence in results |
| External controls included | Facilitates internal laboratory quality control |
| Room temperature storage | No refrigerator space needed. No need to wait for reagents to warm up. Rapid strep A tests can be run immediately as needed. |
PRODUCT SPECIFICATIONS
| Sample type | Throat swab |
| Time to results | 5 minutes |
| Kit storage conditions | Room temperature (15°C to 30°C/59°F to 86°F) |
| Internal Controls | Positive and negative |
| Sensitivity* | 92% |
| Specificity* | 98% |
| Overall accuracy* | 95% |
| Shelf life | 24 months from date of manufacture |
| CLIA complexity | Waived |
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