- A rapid qualitative immunoassay kit engineered for early pregnancy confirmation. It allows healthcare providers to test utilizing either a urine or serum patient sample
Uses
- Pregnancy Confirmation:
- Detects human chorionic gonadotropin (hCG) to visually confirm early-stage pregnancy
- Dual Sample Versatility:
- Validated for analyzing both serum (blood) and urine specimens depending on clinical requirements
- Advanced Gestation Screening:
- Ideal for clinical facilities testing women who may be beyond their first trimester
- Point-of-Care Testing:
- Designed specifically for rapid deployment inside physicians' offices, emergency rooms, and clinical laboratories
Features
- Clinical Accuracy:
- Delivers 100% sensitivity and specificity with urine samples, alongside 99.5% sensitivity and 99% specificity when running serum samples
- Broad Target Detection:
- Capable of detecting intact hCG, the beta (β) subunit of hCG, and breakdown products like β-core fragments
- Minimal Detection Limit:
- Engineered with a highly sensitive detection threshold of 25mIU/mL
- Interference Resistance:
- Formulated to resist inaccurate reporting caused by patient biotin levels
- Complete Kit Contents:
- Contains 25 individual test pouches, 25 specialized transfer pipettes, and QC Inside® (2 additional test sticks dedicated solely to running external quality controls)
Benefits
- Rapid Diagnostic Windows:
- Produces easy-to-read, objective visual confirmations in as little as 3 minutes
- Streamlined Clinical Workflow:
- Demands under 30 seconds of active hands-on time using a simplified, single-step sample application procedure
- Regulatory Compliance Made Easy:
- Holds a CLIA-waived classification when processing urine specimens, permitting operation by standard clinic personnel without advanced laboratory certifications
- Room Temperature Stability:
- Safely stores at normal room temperatures (2–30°C / 36–86°F), removing the necessity for cold-chain refrigeration or storage space
