Healgen Pregnancy hCG Urine Test Dip Card, CLIA Waived 25/Box
The Pregnancy urine test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. hCG is a hormone produced by the placenta, which, in normal subjects, provides an early indication of pregnancy. The One-Step Pregnancy urine test provides a qualitative screening result and is for healthcare professional use only and not for self-testing. The test is available in cassette, strip, dip card, and mid-stream formats.
Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced in pregnancy that is made by the developing embryo after conception and later by the syncytiotrophoblast. In normal pregnancy, hCG can be detected in urine as early as 1-2 weeks after conception. hCG levels continue to rise very rapidly, usually exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. Early pregnancy testing, in general, is based on the detection or measurement of hCG. The Pregnancy One Step Rapid Test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine. Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. At the level of claimed sensitivity, the Pregnancy One Step Rapid Test shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
Features & Benefits
- CLIA Waived & FDA Approved for Urine
- FDA Cleared (510(k)) and OTC Cleared: Meets regulatory standards for safety and efficacy
- Sensitivity: Detects hCG levels as low as 25 mIU
- High Accuracy: Over 99% accurate according to Healgen’s clinical data
- Simple one-step procedure
- Speedy results; minimizes user error
- Rapid Results: Visual results available within minutes after dipping the card in urine
- Built-in Control Indicates the test has been performed correctly
- 12-18-month shelf life at room temp. (from date of manufacture)
- Storage & Shelf Life: Store between 2-30°C with a typical shelf life of 24 months (expiration date generally 11 months or longer)
- No special storage requirements to maintain stability
- Consistent, on-time supply & superior customer service / technical support
| hCG Urine Test Dip Card | |
| Method | Lateral flow test |
| Sensitivity / Detection Level | 25 mIU/mL |
| Accuracy | > 99% |
| Sample | Urine |
| Read time | 3-5 minutes |
| Storage | Room temperature |
| Shelf life | 12-18 months from manufacture date |
| CLIA Classification | Waived |
| FDA 510(k) No. | |
How It Works:
- Dip the test card into a urine sample for the specified time, then remove and lay flat.
- Results will appear as visible lines indicating a positive or negative pregnancy status.