Beckman Coulter 37200 Access Hybritech PSA Reagent Kit, 100 Determinations

Description

Beckman Coulter 37200 Access Hybritech PSA Reagent Kit (PSA Test) Specifications:

• Brand: Access Hybritech
• Manufacturer: Beckman Coulter 37200
• Country of Origin: United States
• Application: Access Hybritech PSA Reagent Kit
• For Use With: For Access 2, Unicel DXI, Synchron LXI Systems
• Number of Tests: 2 X 50 Tests
• Storage Requirements: Requires Refrigeration
• Test Method: Chemiluminescent Immunoassay
• Test Name: Prostate specific Antigen (PSA Test)
• Sample Type: Serum Sample
• Test Type: Cancer
• Data Sheet
• Comparison of Three Assays for Total and Free PSA Using Hybritech and WHO Calibrations
• Related Hybritech PSA products :
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  • 2. Beckman Coulter 37205 Access Hybritech PSA Calibrator (S0-S5)
  • 3. Beckman Coulter 37210 Access Hybritech free PSA Reagent, 100 Determinations
  • 4. Beckman Coulter OSR61205 UIBC unsaturated reagent iron binding capacity

Beckman Coulter 37200 Access Hybritech PSA Reagent Kit: INTENDED USE

The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.

This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.

Beckman Coulter 37200 Access Hybritech PSA, PSA Reagent Kit: 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. A reliable test for detecting early stage prostate cancer, when the tumor is confined to the gland and effective treatment can be provided, can be of great value to the physician. Historically, a majority of prostate cancers had advanced beyond the gland at the time of diagnosis.

The digital rectal examination (DRE) is a commonly used technique for prostate cancer detection; nevertheless DRE, as it is generally performed in medical practice, misses a significant number of cancers, including many organ-confined tumors.

A multicenter, prospective clinical study of 6,374 men has provided additional information about the use of Hybritech PSA and DRE in the identification of men with prostate cancer. A summary of the results of this study follows in the “Expected Values” section.

Other clinical applications: Beckman Coulter 37200 Access Hybritech PSA, PSA Reagent Kit

Other clinical applications have been clearly demonstrated for PSA. When employed for the management of prostate cancer patients, serial measurement of PSA is useful in detecting residual tumor and recurrent cancer after radical prostatectomy. Moreover, PSA may serve as an accurate marker for monitoring advancing clinical stage in untreated patients, as well as assessing response to therapy.

Therefore, serial measurement of PSA concentrations can be an important tool in monitoring patients with prostate cancer and in determining the potential and actual effectiveness of surgery or other therapies. Other biochemical markers such as prostatic acid phosphatase (PAP) and carcinoembryonic antigen (CEA) lack sufficient specificity for monitoring disease, and are unsuited for detecting early stage prostate cancer.

Prostate specific antigen (PSA) was identified and purified by Wang and co-workers in 1979. PSA is a single chain glycoprotein with a molecular weight of approximately 34,000 daltons, containing 7% carbohydrate by weight. 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.

The relative concentrations of the two detectable forms within and between patient samples is variable and unknown. However, it has been reported that the concentration of free PSA usually ranges from 5 to 50% of the total PSA in serum.

Hybritech PSA Reagent Kit: What is a prostate-specific antigen (PSA) test?

A prostate-specific antigen (PSA) test is a blood test that measures the level of PSA in a sample of your blood. PSA is a protein made by your prostate. The prostate is a gland in the male reproductive system. It lies just below the bladder. It makes the fluid part of semen.

It’s normal to have a low level of PSA in your blood. A high PSA level may be caused by:

• Prostate cancer
• An enlarged prostate (BPH) (benign prostatic hyperplasia)
• Other common prostate problems
• Taking certain medicines

A PSA test can’t show what is causing abnormal PSA levels. So, if your level is high, you may need other tests.

Other names: total PSA free PSA

Hybritech PSA Reagent Kit:  What is it used for?

A PSA test is used to screen for prostate cancer. Cancer screening means looking for signs of cancer before it causes symptoms. But screening tests can’t diagnose cancer. If a screening test finds signs of cancer, you’ll need other tests to find out if you have cancer and how serious it may be.

Most types of prostate cancer grow very slowly. They don’t spread beyond the prostate and may never cause health problems. In fact, you can live a long life with prostate cancer and never know you have it. The goal of prostate cancer screening is to help find cancers that may be more likely to spread so they can be treated early. But there are challenges and possible harms from using a PSA test to screen for prostate cancer:

• A PSA test can’t tell the different between abnormal PSA levels from prostate cancer and noncancerous conditions. If your PSA level is high, a prostate biopsy is the only way to find out if the cause is cancer. And prostate biopsies have possible harms.
• A PSA test may lead to finding and treating prostate cancer that would never have affected your health. If prostate cancer is found:
  • It can be difficult to tell the difference between slow-growing cancers and those that are likely to grow faster and spread in your body.
  • You could have prostate cancer treatment that you never really needed. And cancer treatment may cause serious harms, such as:
    • Erectile dysfunction
    • Urinary incontinence
    • Problems controlling your bowels (poop)

To decide whether a PSA test to screen for prostate cancer is right for you, talk with your health care provider about:

• Your risk for developing a serious type of prostate cancer. If your risk is high, the possible benefits of finding cancer early may outweigh the possible harms.
• Your general health. Are you well enough to have treatment for prostate cancer if it’s found?
• Your preferences. How do you feel about the possible benefits and harms of screening, diagnosis, and treatment?

PSA testing may also be used to:

• Help diagnose the cause of prostate conditions that aren’t cancer
• Monitor treatment for a prostate condition, including cancer