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

A direct solid phase enzyme immunoassay for the quantitative determination of Total Prostatic Specific Antigen (tPSA) in human serum or plasma. tPSA is intended for laboratory use only.

Scientific Description
Prostate Specific Antigen (PSA) is a serine protease with chymotrypsin-like activity1,2.  The protein is a single chain glycoprotein with a molecular weight of 28.4 kDa3.  The name PSA derives from the observation that PSA is a specific antigen of the prostrate and it is not found in other tissues.
PSA is found in benign, malignant and metastatic prostate cancer.  Since prostate cancer is the second most prevalent form of male malignancy, the detection of elevated PSA levels plays an important role in the early diagnosis. Due to increased sensitivity, serum PSA levels are more useful than prostatic acid phosphatase (PAP) in the diagnosis and management of patients4.

1. Christensson A, Laurell CB, Lilja H., Eur J Biochem, 194, 755- 63 (1990).
2. Watt KW, et. al., Proc Nat Acad Sci USA, 83, 3166-70 (1986).
3. Chen Z, Prestiglacomo A, Stamey T., Clin Chem, 41, 1273-82 (1995).
4. Wild D, The Immunoassay Handbook., Stockton Press (1994) p. 452.
5. Junker R, Brandt B, Zechel C, Assmann G, Clin Chem, 43, 1588- 94 (1997).
6. Prestigiacomo AF, Stamey TA, ‘ Physiological variations of serum prostate antigen in the (4-10 ng/ml) range in male volunteers.’ J. Urol 1996; 155:1977-80.
7. Stamey TA, McNeal JE, Yemoto CM, Sigal BM, Johnstone IM,‘Biological determinants of cancer progression in men with prostate cancer.’ JAMA 1999;281:1395-1400.
8. Chen Z, Prestigiacomo A, Stamey T, ‘Purification and characterization of Prostate Specific Antigen (PSA) Complexed to a1 Anticymotrypsin:Potential reference Material for International Standardization of PSA Immunoassays.’ Clin Chem. 1995; 41/9:1273-1282.
9. Horton GL, Bahnson RR, Datt M, Cfhan KM, Catalona WJ and Landenson JH.’Differences in values obtained with two assays of Prostate Specific Antigen.’ J. Urol. 1988;139:762-72.
10. Stenman UH, Leinonen J, Alfthan H, Rannikko S, Tuhkanen Kand Alfthan O.’A complex between prostate specific antigen anda1-anticymotrypsin is the major form of prostate specific antigenin serum of patients with prostate cancer:assay of complex improves clinical sensitivity for cancer.’ Cancer Res.1991;51:222-26.

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Code: DKO057
Clinical Area:
Incubation: 30+15 min
Sensitivity: N/A
Specificity: N/A
Classification: RUO
Number of Tests: 96
Sample Type: Serum/Plasma
Sample Volume: 25 µL
Assay Range: 5 - 100 ng/mL