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QuickVue hCG Urine Test
PregnancyThe QuickVue hCG Urine Test is a sensitive immunoassay that detects human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
INTENDED USE
The QuickVue hCG Urine Test is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by healthcare professionals.
FEATURES & BENEFITS
| Feature | Benefit |
| One-step procedure | Easy to use, fewer procedural errors |
| Results in 3 minutes | Fast time to results |
| Two-color result | Easy to read and interpret |
| High sensitivity | Ability to detect low hCG levels as early as 2-3 days before expected menses |
| Self-contained test Cassette | Clean, easy to use and dispose of |
| Pictorial Procedure Card | Clear and simple illustrations to guide the hCG test procedure |
| All components included in kit | Ready to use, no need for additional equipment |
| External controls available | Facilitates internal laboratory quality control |
| Room temperature storage | No refrigerator space needed. No need to wait for reagents to warm up. Rapid pregnancy urine tests. Tests can be run immediately as needed. |
PRODUCT SPECIFICATIONS
| Sample type | Serum, urine |
| Sample size | 3 drops |
| Time to results | 3 minutes |
| Kit storage conditions | Room temperature (15°C to 30°C/59°F to 86°F) |
| Internal Controls | Included |
| External Controls | Available separately |
| Sensitivity* | 25 mIU/mL |
| Accuracy* | >99% |
| Shelf life | 18 months from date of manufacture |
| CLIA complexity | Waived for urine, moderate for serum |
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