QUIDEL® QuickVue+® One-Step hCG Combo Test – 30 Test Kit
Rapid test for the early detection of pregnancy using serum or urine samples.
The QuickVue+® One-Step hCG Combo Test is a CLIA-waived, qualitative immunoassay designed to detect human chorionic gonadotropin (hCG) in either serum or urine specimens. This test uses monoclonal antibodies specific to the beta subunit of hCG, ensuring high specificity and early pregnancy detection. Its clearly distinguishable +/- visual endpoint and single-step format make it ideal for quick, reliable results in point-of-care settings.
Key Benefits
• Detects hCG in serum or urine specimens
• Clearly visible + / – result line for confident interpretation
• Uses beta subunit-specific monoclonal antibodies
• One-step test with no additional reagents required
• CLIA-waived for use at point-of-care
• Early pregnancy detection with high sensitivity
• Room temperature storage
Performance Characteristics
• Sensitivity: 25 mIU/mL (urine), 10 mIU/mL (serum)
• Specificity: >99%
• Time to Results: 3–5 minutes
Intended Use
For the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine to aid in the early diagnosis of pregnancy.
Kit Contents
• 30 test cassettes
• Disposable droppers
• Package insert with instructions for use
Packaging Details
• 30 tests per kit
• CLIA-waived classification
• Compatible with serum or urine specimens
• Room temperature storage (59–86°F)