Total PSA

Key Features and Values
  • Same sample type can be used across all assays to simplify inclusion into routine serology work-up
  • Ready to use reagents reduces hands-on time for assay preparation
  • Long shelf life cost-effective solution by reducing wastage due to expired kits
  • Suitable for inclusion on automated plate systems simplifies scale-up of test volume
  • Supported by a complete panel of assays for supporting treatment monitoring of several forms of cancer
Product Description

Total PSA ELISA is used for the quantitative determination of total Prostate Specific Antigen (t-PSA) in human serum or plasma samples. The determination of total PSA levels is used to help estimate the risk of prostate carcinoma in men in conjunction with digital rectal examination (DRE) or to help monitor the effectiveness of prostate carcinoma treatment in patients.

Scientific Description
Prostate cancer is the most frequent type of cancer found in man and is the second cause of death due to cancer in males.  Until recently, digital rectal examination (DRE) was frequently used as only diagnostic modality for the detection of early stages of prostate cancer.  In the recent years the determination of serum PSA levels has become the most accepted method to improve the diagnostic specificity of DRE.  Although PSA is a tissue specific protein and is not solely tumour specific, it has become the most important marker for prostate carcinoma, showing a better specificity than other biochemical markers used in this context (PAP, total alkaline phosphatase, carcinoembryonic antigen, etc.).
In 1979, Wang et al isolated a specific antigen for normal prostate tissue and called this protein PSA.  As demonstrated by immunohistological studies, PSA is localised in the cytoplasm of prostate acinar cells, ductal epithelium and in the secretion on the ductal lumina, present in normal, benign hyperplastic and malignant prostate tissues as well metastatic prostate cancer and in seminal plasma.  If the structural integrity of the prostate is disturbed and/or the gland size is increased, the amount of PSA in the blood plasma may become elevated.  An elevation of PSA levels to values higher than 3-4 ng/ml has been reported for patients with either benign prostatic hypertrophy (BPH) or prostate carcinoma.  At this threshold follow-up examinations that allow to differentiate between these two conditions are recommended.
The determination of PSA serum levels is not only important for the screening of patients for prostate cancer, but also for monitoring patients that have been treated for this disease.  Here regular PSA measurements are an important tool to examine the potential and actual effectiveness of surgery or other therapies.  An increase of PSA in patients after radical prostatectomy or radiotherapy may allow an earlier discovery of residual or recurrent carcinoma.
Publications

1. Fritsche HA und RJ. Babalan Clin Chem (1993) Vol 39: 1529-1529 Analytical performance goals for measuring prostate-specific antigen
2. Milford Ward A. et al., Ann Clin Biochem (2001), Vol 38: 633-651 Prostate specific antigen: biology, biochemistry and available commercial assays.
3. Price C. P. et al., Ann Clin Biochem (2001), Vol 38: 188-216 Pre-and post-analytical factors that may influence use of serum prostrate specific antigen and its isoforms in a screening programme for prostate cancer.
4. Lange P et al., J Urol (1989) Vol 141:873. The value of serum prostate-specific antigen determinations before and after radical prostatectomy.
5. Akdas et al. British J Uro (1997) Vol 79: 920-923. The role of free prostate specific antigen in the diagnosis of prostate cancer.

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Code: DKO137
Clinical Area:
Incubation: 5+60+20 min
Analytical range: 1.56 - 25 ng/mL
Sensitivity: N/A
Specificity: N/A
Classification: IVD, CE
Number of Tests: 96
Sample Type: Serum or plasma (heparin, citrate or EDTA)
Sample Volume: 25 μL
Assay Range: 1.56 - 25 ng/mL