Urine Analysis
Intended Use
The Precious Feet Premium Pregnancy Test manufactured for Heritage House 76, Inc. (PFPT) is used for the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine.
Summary
hCG is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected as early as 7 - 10 days after conception. The PFPT is sensitive to 20 mlU/ml hCG and is 99% accurate.
Specimen Collection
A fresh urine specimen should be used, no special pre-treatment is necessary. Specimens may be collected at any time of the day, although the first morning urine generally contains the highest concentration of hCG. Specimens will be collected during the visit at the Pregnancy Care Center.
Limitations
1. False negative results may occur when the levels of hCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine should be collected 48 hours later and tested.
2. As with any assay employing antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens my cause false positive or false negative results.
3. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings are evaluated.
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