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Total Prostate Specific Antigen (Total PSA) ELISA Kit

INTENDED USE

Human total PSA ELISA kit is a procedure for analysing in vitro quantitative concentrations of total prostate specific antigen (total PSA, kallikrein-3, gamma-seminoprotein) in human serum and plasma. This assay has a minimum sensitivity limit of 0.2 ng/ml.

BACKGROUND

Prostate specific antigen (PSA) is a glycoprotein which can be produced by the prostate gland, bulbourethral gland and lining of the urethra. PSA has become a vital marker for prostate carcinoma, it offers better sensitivity and specificity when compared to other biochemical marker such as total alkaline phosphatase, PAP and carcinoembryonic antigen. Usually there is very little prostate specific antigen which is secreted in the blood, however, increase in tissue damage and glandular size can result in prostate cancer, prostatitis and benign prostatic hypertrophy which can lead to an increase in the levels of circulating PSA.

Prostate specific antigen is found to exist in serum in multiple forms: enveloped by alpha-2-macroglobulin, complexed to alpha-1-anti-chymotrypsin (PSA-ACT complex) and unbound. Higher total PSA concentrations and lower percentages of free PSA have been associated with higher risks of prostate cancer. A total PSA range of 4.0-10.0 ng/mL has been identified as a diagnostic “gray zone,” whereby the free to total PSA ratio can be useful in helping to determine the relative risk of prostate cancer. Therefore, many urologists are recommending using the free to total PSA ratio in order to identify which men should undergo biopsy. There is evidence that up to 20% of men that had a negative biopsy result were found to have the cancer. Therefore, regular analysis of prostate specific antigen is crucial tool in order to examine the actual and potential and effectiveness of surgery and other therapies. The measurement of total PSA serum levels is not only vital to screen patients for prostate cancer, but is also important to monitor patients that have been treated for this disease. An increase in levels of kallikrein-3 in patients following radiotherapy or radical prostatectomy could allow an earlier discovery of recurrent or residual carcinoma.

TOTAL PSA ELISA KIT CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • Microtiterwells: Wells coated with anti-PSA antibody (monoclonal).
  • Zero Standard.
  • Sample Diluent.
  • Standards (1-5): Concentrations 1.56, 3.12, 6.25, 12.5, 25.0 ng/mL. Standards are calibrated against the WHO Standard 96/670. Contain non-mercury preservative.
  • Control Low.
  • Control High.
  • Enzyme Conjugate: Anti-PSA antibody conjugated to horseradish peroxidase.
  • Substrate Solution: Tetramethylbenzidine (TMB).
  • Stop Solution: Contains 0.5 M H2SO4, avoid contact.

SENSITIVITY

The minimum detection sensitivity level of total prostate specific antigen (total PSA, gamma-seminoprotein, kallikrein-3) using current human total PSA ELISA kit was 0.2 ng/ml. The dynamic range for this assay is 1.56 – 25.0 ng/ml.

ASSAY CHARACTERISTICS

– Total Prostate Specific Antigen (Total PSA): ELISA
– Detection limit: 0.2 ng/mL
– Precision Intra-Assay: 3.9 – 8.8%
– Precision Inter-Assay: 6.70 –7.98%
– Recovery: 98 – 108%
– Specificity: The antibodies are highly specific for total PSA, with a relatively low cross-reactivity to other proteins and polypeptides, lipids or chemotherapeutic agents that might be present in patient samples.
– High Dose Hook Effect: Up to a PSA concentration of 2000 ng/mL no hook effect was observed.

REFERENCES

  1. Clinical utility of measurements of free and total prostate-specific antigen (PSA): a review. Prostate Suppl. (1996) 7: 64-9. Review. Catalona W.J.
  2. Screening for Prostate Cancer-Beyond Total PSA, Utilization of Novel Biomarkers. Curr Urol Rep. (2015) 16 (9): 63. Review. Morgan T., et al.
  3. Early detection of prostate cancer: is PSA a reliable option? Tex Med. (2001) 97 (2): 59-62. Review. Okihara K. and Babaian R.J.
  4. Discordant total and free prostate-specific antigen (PSA) assays: does calibration with WHO reference materials diminish the problem? Clin Chem Lab Med. (2009) 47 (11): 1325-31. Review. Stephan C., et al.

ADDITIONAL INFORMATION

  • Full Name: Total Prostate Specific Antigen (Total PSA) ELISA Kit
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 0.2 ng/ml

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