For professional and in vitro diagnostic use only.
[INTENDED USE]
The PSA Rapid Test Cassette is a rapid chromatographic immunoassay for
the qualitative detection of human prostate specific antigen in Whole
Blood/Serum/Plasma. The test is based on immunochromatography and can
give a result within 15 minutes.
[SUMMARY]
Prostate cancer is the one of the most common types of cancer found in
man. The incidence of prostate cancer increases with age and accounts for a
growing number of newly diagnosed patients. Prostate specific antigen
(PSA) is produced primarily in the prostate gland and is secreted into the
prostate ducts and at ejaculation serves to liquefy the seminal coagulum.
Virtually all healthy males under 50 years of age have PSA concentration
under 4.0ng/ml. If PSA level is above 10ng/ml, the patient most likely to have
prostate cancer. Some studies indicated that elevated total PSA levels are
found in Whole Blood/Serum/Plasma from patients who have prostate
cancer cells metastasized throughout their bodies. Other studies indicated
that Free PSA, which cannot form a complex with serine protease, tends to
be more abundant in patients with benign prostatic hyperplasia.