QUIDEL® QuickVue® One-Step hCG Urine Test – 25 Test Kit
Rapid pregnancy test for qualitative detection of hCG in urine.
The QuickVue® One-Step hCG Urine Test is a CLIA-waived immunoassay designed for the early detection of pregnancy using urine specimens. This easy-to-use test delivers reliable results in 3 minutes or less with a clearly visible endpoint. It detects hCG concentrations as low as 25 mIU/mL and provides greater than 99% sensitivity, specificity, and overall accuracy. The one-step format requires just 3 drops of urine, making it ideal for point-of-care settings.
Key Benefits
• Detects pregnancy using urine specimens only
• Results in 3 minutes or less
• One-step procedure using only 3 drops of urine
• Sensitivity as low as 25 mIU/mL
• Greater than 99% sensitivity, specificity, and accuracy
• CLIA-waived for use at point-of-care
• Room temperature storage
Performance Characteristics
• Sensitivity: ≥99% at 25 mIU/mL hCG
• Specificity: >99%
• Accuracy: >99%
• Time to Results: 3 minutes or less
Intended Use
For the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early diagnosis of pregnancy.
Kit Contents
• 25 test cassettes
• Disposable droppers
• Instructions for use
Packaging Details
• 25 tests per kit
• CLIA-waived classification
• For use with urine specimens only
• Room temperature storage (59–86°F)