Healthy Clinical Trial
Official title:
Clinical Evaluation to Determine the Expected Values Distribution of β-hCG for the RAMP® Total β-hCG Test in a Healthy, Non-pregnant Reference Population
Prospective, single-centre study to determine the reference range (95th percentile) of human chorionic gonadotropin (hCG) levels in a healthy, non-pregnant, adult female population using the RAMP® Total β-hCG test.
Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the placenta shortly
after implantation of a fertilized ovum into the uterine wall and the rapid rise of blood hCG
concentration after conception makes it an excellent marker for confirmation and monitoring
of early pregnancy. As such, levels in the blood of non-pregnant premenopausal individuals
are low, typically < 5 mIU/mL (milli-International Unit per milliliter).
In terms of identifying a clinically significant range of expected hCG values as determined
by the RAMP β-hCG test, a 95th percentile of a healthy, non-pregnant, adult female reference
population [upper reference limit (URL)] shall be determined in this study.
Subjects who meet the inclusion and exclusion criteria, and give informed consent will be
enrolled in this study. Because hCG levels in blood increase with age, the study population
will be divided into two age groups: 18 to 40 years and >40 years, with approximately 125
subjects per group.
One EDTA (ethylenediaminetetraacetic acid) blood sample will be collected from each subject
via standard venipuncture. The maximum trial duration for each subject will be one
visit/blood draw.
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