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QuickVue hCG Combo Test
Women’s HealthThe QuickVue hCG Combo Test is a sensitive immunoassay that detects human chorionic gonadotropin (hCG) in serum or urine for the early detection of pregnancy.
INTENDED USE
The QuickVue One-Step hCG Combo test is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or 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 to 5 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 |
| 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. |
PRODUCT SPECIFICATIONS
| Sample type | Serum, urine |
| Sample size | 3 drops |
| Time to results | Serum – 5 minutes; Urine – 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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