- A small-volume 30-test configuration. It is a sensitive rapid diagnostic immunoassay used by healthcare professionals for the early qualitative detection of human Chorionic Gonadotropin (hCG) to confirm pregnancy
Uses
- Early Pregnancy Screening:
- Detects minimal elevations of the pregnancy hormone hCG
- Dual Specimen Validation:
- Assays pregnancy status using either a urine or blood serum matrix
- Pre-Treatment Clearance:
- Safely screens patients of childbearing age prior to surgeries, therapeutic medication delivery, or X-rays
Features
- Bulk Packaging Architecture:
- Packaged as a large-capacity kit containing 30 individually wrapped test cassettes per box
- Rapid Action Processing:
- Delivers final, definitive results within 3 minutes for urine and 5 minutes for serum
- Increased Sensitivity Thresholds:
- Detects low hCG levels up to 10mIU/mL in serum and 20mIU/mL in urine
- Early Conception Capture:
- Identifies positive indicators as early as 2 to 3 days before a missed period
- Visual Plus/Minus Sign Indicator:
- Features a highly intuitive readout displaying a distinct plus (+) for positive or minus (-) for negative
- Dual CLIA Complexity Status:
- Granted a CLIA Waived designation for urine and a Moderate Complexity designation for serum
- Shelf Stability:
- Stores safely at room temperature (59°F to 86°F), removing refrigeration constraints
Benefits
- High Clinical Confidence:
- Offers greater than 99% overall accuracy and specificity, eliminating baseline diagnostic ambiguity
- Foolproof Result Readings:
- The prominent plus/minus graphic display leaves no room for line interpretation confusion among clinic workers
- True One-Step Testing Workflow:
- Minimizes manual fluid interaction, dropping the rate of operator processing error
- Integrated Process Control:
- Confirms fluid movement and functional component integrity automatically via internal control features
