Description
Unit: 1 Box (25 Tests)
Regulatory Status: CLIA Waived (Urine) / Professional Use Only
Contents: (25) Test Strip, (25 droppers), (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 (Cassette) 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.
- Sensitivity of 25 mlU/ml
- Specificity of 100% – No cross reaction with FSH/TSH/LH
- 99% overall accuracy
- CLIA Waived
- 24 month dating
- Comes in boxes of 25 and 50 cassettes
Human chorionic gonadotropin (hCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine. The pregnancy test contains antibodies which specifically react with this hormone.
Capillary action carries the specimen to migrate along the membrane. When hCG in the sample reaches the Test Zone region of the membrane, it will form a colored line. Absence of this colored line suggests a negative result.
To serve as a procedure control, a colored line will appear at the control zone region, if the test has been performed properly
