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Beckman Coulter Access Hybritech free PSA Reagent, 100 Determinations, 2 x 50 tests

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    Product Code: 37210

    Manufacturer: Beckman Coulter

    Shipping Weight: 10.00lbs (4.54kg)

    Specifications

    Brand: Access® Hybritech®

    Manufacturer: Beckman Coulter

    Country of Origin: United States

    Application: Reagent

    For Use With: For Synchron LXI, Unicel DXI, Access 2

    Number of Tests: 2 X 50 Tests

    Test Name: Free Prostate-specific Antigen (PSA)

    Test Type: Cancer

    Intended Use 

    The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated foruse as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.

    Summary and Explanation

    Prostate cancer is the most common type of cancer found in men in the United States, with an incidence of approximately

    one case for every ten men. It is also the second leading cause of cancer deaths among American men.

    Prostate-specific antigen was identified and purified by Wang and co-workers in 1979. PSA, a serine protease, is produced by the epithelial cells of the prostate, and is produced by both benign and malignant cells. Abnormalities in the prostate gland architecture resulting from trauma or disease can lead to “leakage” of PSA into the bloodstream.

    PSA exists primarily as three forms in serum. One form of PSA is believed to be enveloped by the protease inhibitor, alpha-2 macroglobulin and has been shown to lack immunoreactivity. A second form is complexed to another protease inhibitor, alpha-1 antichymotrypsin (ACT). The third form of PSA is not complexed to a protease inhibitor, and is termed free PSA. The latter two forms are immunologically detectable in commercially available PSA assays and are referred to collectively as total PSA.