- A highly sensitive rapid diagnostic tool used by healthcare professionals for the early qualitative detection of human Chorionic Gonadotropin (hCG) to confirm pregnancy
Uses
- Early Pregnancy Detection:
- Identifies low levels of the pregnancy hormone hCG
- Dual Specimen Testing:
- Validates pregnancy using either a urine or a blood serum sample
- Pre-Procedure Screening:
- Screens patients of childbearing age before surgical procedures, sedation, or colonoscopies to avoid risking fetal health
Features
- Dual CLIA Complexity Status:
- Holds a CLIA Waived classification for urine samples and a Moderate Complexity classification for serum
- Rapid Diagnostic Windows:
- Delivers easy-to-read results in just 3 minutes for urine and 5 minutes for serum
- High Sensitivity Threshold:
- Detects hCG concentrations as low as 25 mIU/mL, catching pregnancy 2 to 3 days before a missed period
- Two-Color Readout:
- Displays a distinct pink-to-red Test line alongside a blue procedural Control line
- Monoclonal Antibody Technology:
- Uses targeted antibodies specific to the beta subunit of hCG to prevent cross-reactivity
- Self-Contained Cassette Pack:
- Arrives as a bulk pack of 50 individually wrapped tests with disposable transfer pipettes included
- Room Temperature Storage:
- Stores safely on standard medical shelves between 59°F and 86°F (15°C to 30°C), eliminating refrigeration needs
Benefits
- High Clinical Confidence:
- Offers greater than 99% accuracy, sensitivity, and specificity for trusted results
- Streamlined Protocol:
- Lowers the margin for operator error with a simple, true one-step procedure requiring only 3 drops of a sample
- Fast Clinical Workflows:
- Accelerates hospital or clinical decision-making when clear clearance is required before medical treatments
- In-Office Testing Integrity:
- Confirms correct liquid flow and strip functionality automatically via an internal blue procedural control line
