INTENDED USE

Diagnostic Kit for free Prostate Specific Antigen (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of free Prostate Specific Antigen (fPSA) in human serum or plasma. The ratio of fPSA/tPSA can be used in the differential diagnosis of prostate cancer and benign prostatic hyperplasia. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

Free prostate-specific antigen (fPSA) is a prostate-specific antigen released into the blood in a free form and secreted by prostate epithelial cells. PSA（Prostate Specific Antigen） is synthesized and secreted by prostate epithelial cells into semen and is one of the main components of seminal plasma.It contains 237 amino acid residues and its molecular weight is about 34kD.It has serine protease activity of the single chain glycoprotein,participate in the process of semen liquefaction. PSA in the blood is the sum of the free PSA and the combined PSA. the blood plasma levels, in 4 ng/mL for the critical value, the PSA in prostate cancer Ⅰ ~ Ⅳ period of the sensitivity of 63%, 71%, 81% and 88% respectivel.