Total PSA ELISA Kit (Prostate Specific Antigen)
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) that is a glycoprotein produced by; the prostate gland, bulbourethral gland and lining of the urethra. It 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. It 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. A 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.
Many urologists are recommending using the free to total PSA ratio in order to identify which men should undergo biopsy. Up to 20% of men that had a negative biopsy result were found to have the cancer. Therefore, regular analysis is crucial tool in order to examine the actual and potential and effectiveness of surgery and other therapies.
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 total PSA ELISA kit was 0.2 ng/ml. The dynamic range for this assay is 1.56 – 25.0 ng/ml.
ASSAY CHARACTERISTICS
– 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
- Clinical utility of measurements of free and total prostate-specific antigen (PSA): a review. Prostate Suppl. (1996) 7: 64-9. Review. Catalona W.J.
- Screening for Prostate Cancer-Beyond Total PSA, Utilization of Novel Biomarkers. Curr Urol Rep. (2015) 16 (9): 63. Review. Morgan T., et al.
- Early detection of prostate cancer: is PSA a reliable option? Tex Med. (2001) 97 (2): 59-62. Review. Okihara K. and Babaian R.J.
- 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 PSA ELISA Kit (Prostate Specific Antigen)
- Reactivity: Human
- Sample Type: Serum, Plasma
- Sensitivity: 0.2 ng/ml
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