Description
Unit: 1 Box (25 Tests)
Regulatory Status: CLIA Waived (Urine) / Professional Use Only
Contents: (25) Test Strip, (1) Package Insert
Determinations: Qualitative Human Chorionic Gonadotropin (hCG)
Storage Requirements: 35° – 86° F
Processing Time: 5 Minutes (Urine)
The Clarity Pregnancy One Step Rapid Test (Strip) is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy.
For professional use and OTC self test use.
- One-Step
- Specificity: 100%
- Sensitivity: 25mIU/ml
- 99% Overall Accuracy
- Built-in Quality Control
- 24 Month Dating (from manufacturing)
- Room Temperature Storage
Human chorionic gonadotropin (hCG) is a glycoprotien 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 Clarity 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 Clarity Pregnancy One Step Rapid Test shows no cross-reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.
