INTENDED USE

The Prostate Specific Antigen (PSA) Rapid Test Strip is a rapid detection of Prostate Specific Antigen(PSA) tumor markers in human whole blood, serum or plasma. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
Any reactive specimen with the Prostate Specific Antigen (PSA) Rapid Test Strip must be confirmed with alternative testing method(s) such as ELISA or PCR.

INTRODUCTION

Prostate cancer is now the most frequently diagnosed cancer in male and considered as the leading cause of mortality due to cancer.Prostate cancer’s incidence increases dramatically in males over 40 years, occurring in 50% of those over 70 years. Compared to other cancers prostate cancer is more succesfully treated if diagnosed early. Digital rectal examination has been a useful procedure in early detection of prostate cancer but it has been shown of having limitations. Also the biochemical markers which are available to monitor this disease (i.e.prostatic acid phosphatase, total alkaline phosphatase, carcinoembryonic antigen,creatine kinase isoenzyme BB etc.) are not specific for prostate cancer. Therefore, the management of patients with prostate cancer has been hindered by the lack of a more accurate markers.
Recently, another prostate enzyme has been identified and purified, which is specific for prostate tissue, normal or malignant and also found in periurethral glands.This enzyme is called prostate specific antigen (PSA).Human PSA is a single chain glycoprotein with a molecular weight of approx. 30 kDa containing 8% of carbohydrate by weight. Evaluate levels of PSA in serum have been detected in men with prostate cancer,benign prostate hyperplasia (BPH) and in some cases of inflammatory disorders of other genito-urinary tissues in proximity to the prostate. Increased levels are not observed in healthy men or those with cancers other than the prostate. Females who are healthy or have cancer do not exhibit PSA. Serial testing for elevated levels of PSA in serum can provide an important tool in the monitoring of disease reccurrence or in following the effectiveness of a particular treatment.

PRINCIPLE

The prostate specific antigen(PSA) is the most commonly tested Tumor marker for the prostate gland disease diagnosis. PSA tumor marker is normally present in low levels in the blood of all adult men. In human blood, the normal concentration range of this biomarker is 0.0 to 4.0 ng/ml, which are variable among different human races (refer to the table at the end of this page). But when prostate specific antigen rise beyond the normal range, it can be taken as a signal of prostate gland cancer or other problems. That is why PSA becomes the subject of PSA serum or plasma detection devices.
This product is composed of the glass fiber strips of monoclonal antibody against Prostate Specific Antigen(PSA), anti-rabbit IgG solid cellulose nitrate (mixing) membrane and the bonders of absorptive colloidal gold – monoclonal antibody against PSA.It adopts the principles of double antibody sandwich method and immunochromatography to test the PSA in whole blood, serum or plasma.