Department

Chemistry

Collect

Serum (0.4 mL)

Specimen Preparation

Allow sample to clot adequately before centrifuge and refrigerate sample at 4 deg C.

Unacceptable Conditions

Grossly hemolysed serum

Stability (from collection to initiation)

Stability: Room Temperature   8 hours

             Refrigerated             48 hours

             Frozen                     Longer storage. FREEZE ONLY ONCE.

             Keep sample tubes stoppered and upright at all times.

Synonyms

  • Prostate Specific Antigen

Notes

Alternate Name: PSA

*** For Post-Prostatectomy Prostate Specific Antigen (PSA) with sensitivity to 0.01 ng/mL - SEND OUT
    ORDER: Miscellaneous test
                 Post-Protatectomy Ultra-sensitive Prostate Specific Antigen
                 ARUP REFERENCE # 0098581
 

Remarks

Performed daily.

Sample must be drawn before undergoing prostate manipulation, specially needle biopsy and transurethral resection to avoid erroneously high results.

Reference Interval

                    Male Age: 0-49 yrs      Range: 0.00-2.50 ng/mL
                                   50-59 yrs                0.00-3.50 ng/mL
                                   60-69 yrs                0.00-4.50 ng/mL
                                   >= 70 yrs                0.00-6.50 ng/mL

Interpretive Data

Limitations:
The PSA assay is intended to be used as an aid in the detection of prostate cancer and as an aid
in the management (monitoring) of prostate cancer patients, in accordance with current
clinical practice guidelines. These guidelines define biochemical recurrence of prostate cancer
as a detectable or rising PSA value post-radical prostatectomy that is ≥ 0.20 ng/mL (ug/L) with
a second confirmatory level of ≥ 0.20 ng/mL (ug/L), thus use of PSA values < 0.20 ng/mL
(ug/L) is not recommended to identify patients at risk of biochemical recurrence of prostate
cancer. 13, 14
Specimens obtained from patients undergoing prostate manipulation, especially needle biopsy
and transurethral resection, may show erroneously high results.6 Care should be taken that
PSA samples are drawn before these procedures are performed.
Prostate cancer patients under treatment with anti-androgens and LHRH agonists may exhibit
markedly reduced levels of PSA. Also, men treated for benign prostatic hyperplasia with
inhibitors of 5α-reductase (finasteride) may demonstrate a significant reduction in PSA levels
compared to values prior to treatment.15 Care should be taken when interpreting values from
these individuals.
The concentration of PSA in a given specimen determined with assays from different
manufacturers can vary because of differences in assay methods, calibration, and reagent
specificity.16 PSA in serum and in seminal fluid exists primarily in complexed and free forms,
respectively.17 Quality control samples may be produced by introducing seminal fluid PSA into
serum matrices. PSA levels in these controls, determined with different manufacturers’ assays,
will vary depending on the method of standardization, antibody specificity, and different
reactivity with complexed and free forms of PSA. Therefore, it is important to use assay specific
values to evaluate quality control results.
Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering
with in vitro immunoassays.18 Patients routinely exposed to animals or to animal serum
products can be prone to this interference and anomalous values may be observed. Additional
information may be required for diagnosis.
WARNING:
Do not predict disease recurrence solely on serial PSA values.
Note:
Do not interpret levels of PSA as absolute evidence of the presence or the absence of malignant disease.
Before treatment, patients with confirmed prostate carcinoma frequently have levels of PSA within the
range observed in healthy individuals. Elevated levels of PSA can be observed in patients with
nonmalignant diseases. Measurements of PSA should always be used in conjunction with other
diagnostic procedures, including information from the patient’s clinical evaluation.
The concentration of total PSA in a given specimen determined with assays from different manufacturers
can vary due to differences in assay methods, calibration, and reagent specificity. Total PSA determined
with different manufacturers’ assays will vary depending on the method of standardization and antibody specificity.


References:
1. Wang MC, Valenzuala LA, Murphy GP, and Chu TM. Purification of a human
prostate-specific antigen. Invest Urol. 1979;17:159–160.
2. Watt KWK, Lee PJ, M’Timkulu T, et al. Human prostate-specific antigen: structural and
functional similarity with serine proteases. Proc Nat Acad Sci. 1986;83:3166–3170.
3. Lilja HA. Kallikrein-like serine protease in prostatic fluid cleaves the predominant seminal
vesicle protein. J Clin Invest. 1985;76:1899–1903.
4. Stamey TA, Yang N, Hay AR, et al. Prostate-specific antigen as a serum marker for
adeno-carcinoma of the prostate. New Eng J Med. 1987;317(15):908–916.
5. Schellhammer PF, Schlossberg SM, El-Mahdi, et al. Prostate-specific antigen levels after
definitive irradiation for carcinoma of the prostate. J Urol. 1991;145:1008–1010.
6. Catalona WJ, Smith DS, Ratliff TL, et. al. Measurement of prostate-specific antigen in serum
as a screening test for prostate cancer. New Eng J Med. 1991;324(17):1156–1161.
7. Cooner WH, Mosley BR, Rutherford LL, et al. Prostate cancer detection in a clinical
urological practice by ultrasonography, digital rectal examination and prostate specific
antigen. J Urol. 2002;167:966–973.
8. Oesterling JE. Prostate specific antigen: a critical assessment of the most useful tumor
marker for adeno carcinoma of the prostate. J Urol. 1991;145:907–923.
9. Stamey TA, Kabalin JN, McNeal JE, et al. Prostate specific antigen in the diagnosis and
treatment of adeno carcinoma of the prostate. II. Radical prostatectomy treated patients.
J Urol. 1989;141:1076–1083.
10. Lange PH, Ercole CJ, Lightner DJ, et al. The value of serum prostate specific antigen
determinations before and after radical prostatectomy. J Urol. 1989;141:873–879.
11. Killian CS, Yang N, Emrich LJ, et al. Prognostic importance of prostate specific antigen for
monitoring patients with stages B2 to D1 prostate cancer. Cancer Res. 1985;45:886–891.
12. Clinical and Laboratory Standards Institute (formerly NCCLS). Procedures for the Handling
and Processing of Blood Specimens; Approved Guideline - Third Edition. Wayne, PA:
Clinical and Laboratory Standards Institute; 2004. NCCLS Document H18-A3.
13. Carter HB, Albertsen PC, Barry MJ. American Urological Association. Early detection of
prostate cancer: AUA Guideline. J Urol. 2013;190(2):419-426.
14. Mottet N, Bellmunt J, Briers E, et al; European Association of Urology. EAU
Guidelines--Prostate Cancer. Arnhem, The Netherlands: European Association of Urology;
2017. https://uroweb.org/guideline/prostate-cancer
15. Gormley GJ, Stoner E, Bruskewitz RC, et al. The effect of finasteride in men with benign
prostatic hyperplasia. New Eng J Med. 1992;327(17):1185–1191.
16. Graves HCB, Wehner N, and Stamey TA. Comparison of a polyclonal and monoclonal
immunoassay for PSA: need for an international antigen standard.
J Urol. 1990;144:1516–1522.
17. Lilja H, Christensson A, Dahlen U, et al. Prostate-specific antigen in serum occurs
predominantly in complex with alpha-a-antichymotrypsin.
Clin Chem 1991;37(9):1618–1625.
18. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all immunoassays.
Clin Chem. 1988;34:27–33.
19. Clinical and Laboratory Standards Institute (formerly NCCLS). How to Define and
Determine Reference Intervals in the Clinical Laboratory; Approved Guideline -
Second Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2000.
NCCLS Document C28-A2.
20. Clinical and Laboratory Standards Institute (formerly NCCLS). Protocols for Determination
of Limits of Detection and Limits of Quantitation; Approved Guideline–Second Edition.
Wayne, PA: Clinical and Laboratory Standards Institute; 2012. CLSI Document EP17-A2.
21. Clinical and Laboratory Standards Institute (formerly NCCLS). Interference Testing in
Clinical Chemistry; Approved Guideline - Second Edition. Wayne, PA:
Clinical and Laboratory Standards Institute; 2005. NCCLS Document EP7-A2.
22. Clinical and Laboratory Standards Institute (formerly NCCLS). Primary reference
preparations used to standardize calibration of immunochemical assays for serum
prostate specific antigen(PSA); Approved Guideline. Wayne, PA: Clinical and Laboratory
Standards Institute; 1997. NCCLS Document I/LA19-A.

ADVIA Centaur XP, and ADVIA Centaur XPT Systems   10994905_EN Rev. Y, 2019-09
Collection

Department

Chemistry

Collect

Serum (0.4 mL)

Specimen Preparation

Allow sample to clot adequately before centrifuge and refrigerate sample at 4 deg C.

Unacceptable Conditions

Grossly hemolysed serum

Stability (from collection to initiation)

Stability: Room Temperature   8 hours

             Refrigerated             48 hours

             Frozen                     Longer storage. FREEZE ONLY ONCE.

             Keep sample tubes stoppered and upright at all times.

Ordering

Synonyms

  • Prostate Specific Antigen

Notes

Alternate Name: PSA

*** For Post-Prostatectomy Prostate Specific Antigen (PSA) with sensitivity to 0.01 ng/mL - SEND OUT
    ORDER: Miscellaneous test
                 Post-Protatectomy Ultra-sensitive Prostate Specific Antigen
                 ARUP REFERENCE # 0098581
 

Remarks

Performed daily.

Sample must be drawn before undergoing prostate manipulation, specially needle biopsy and transurethral resection to avoid erroneously high results.

Result Interpretation

Reference Interval

                    Male Age: 0-49 yrs      Range: 0.00-2.50 ng/mL
                                   50-59 yrs                0.00-3.50 ng/mL
                                   60-69 yrs                0.00-4.50 ng/mL
                                   >= 70 yrs                0.00-6.50 ng/mL

Interpretive Data

Limitations:
The PSA assay is intended to be used as an aid in the detection of prostate cancer and as an aid
in the management (monitoring) of prostate cancer patients, in accordance with current
clinical practice guidelines. These guidelines define biochemical recurrence of prostate cancer
as a detectable or rising PSA value post-radical prostatectomy that is ≥ 0.20 ng/mL (ug/L) with
a second confirmatory level of ≥ 0.20 ng/mL (ug/L), thus use of PSA values < 0.20 ng/mL
(ug/L) is not recommended to identify patients at risk of biochemical recurrence of prostate
cancer. 13, 14
Specimens obtained from patients undergoing prostate manipulation, especially needle biopsy
and transurethral resection, may show erroneously high results.6 Care should be taken that
PSA samples are drawn before these procedures are performed.
Prostate cancer patients under treatment with anti-androgens and LHRH agonists may exhibit
markedly reduced levels of PSA. Also, men treated for benign prostatic hyperplasia with
inhibitors of 5α-reductase (finasteride) may demonstrate a significant reduction in PSA levels
compared to values prior to treatment.15 Care should be taken when interpreting values from
these individuals.
The concentration of PSA in a given specimen determined with assays from different
manufacturers can vary because of differences in assay methods, calibration, and reagent
specificity.16 PSA in serum and in seminal fluid exists primarily in complexed and free forms,
respectively.17 Quality control samples may be produced by introducing seminal fluid PSA into
serum matrices. PSA levels in these controls, determined with different manufacturers’ assays,
will vary depending on the method of standardization, antibody specificity, and different
reactivity with complexed and free forms of PSA. Therefore, it is important to use assay specific
values to evaluate quality control results.
Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering
with in vitro immunoassays.18 Patients routinely exposed to animals or to animal serum
products can be prone to this interference and anomalous values may be observed. Additional
information may be required for diagnosis.
WARNING:
Do not predict disease recurrence solely on serial PSA values.
Note:
Do not interpret levels of PSA as absolute evidence of the presence or the absence of malignant disease.
Before treatment, patients with confirmed prostate carcinoma frequently have levels of PSA within the
range observed in healthy individuals. Elevated levels of PSA can be observed in patients with
nonmalignant diseases. Measurements of PSA should always be used in conjunction with other
diagnostic procedures, including information from the patient’s clinical evaluation.
The concentration of total PSA in a given specimen determined with assays from different manufacturers
can vary due to differences in assay methods, calibration, and reagent specificity. Total PSA determined
with different manufacturers’ assays will vary depending on the method of standardization and antibody specificity.


References:
1. Wang MC, Valenzuala LA, Murphy GP, and Chu TM. Purification of a human
prostate-specific antigen. Invest Urol. 1979;17:159–160.
2. Watt KWK, Lee PJ, M’Timkulu T, et al. Human prostate-specific antigen: structural and
functional similarity with serine proteases. Proc Nat Acad Sci. 1986;83:3166–3170.
3. Lilja HA. Kallikrein-like serine protease in prostatic fluid cleaves the predominant seminal
vesicle protein. J Clin Invest. 1985;76:1899–1903.
4. Stamey TA, Yang N, Hay AR, et al. Prostate-specific antigen as a serum marker for
adeno-carcinoma of the prostate. New Eng J Med. 1987;317(15):908–916.
5. Schellhammer PF, Schlossberg SM, El-Mahdi, et al. Prostate-specific antigen levels after
definitive irradiation for carcinoma of the prostate. J Urol. 1991;145:1008–1010.
6. Catalona WJ, Smith DS, Ratliff TL, et. al. Measurement of prostate-specific antigen in serum
as a screening test for prostate cancer. New Eng J Med. 1991;324(17):1156–1161.
7. Cooner WH, Mosley BR, Rutherford LL, et al. Prostate cancer detection in a clinical
urological practice by ultrasonography, digital rectal examination and prostate specific
antigen. J Urol. 2002;167:966–973.
8. Oesterling JE. Prostate specific antigen: a critical assessment of the most useful tumor
marker for adeno carcinoma of the prostate. J Urol. 1991;145:907–923.
9. Stamey TA, Kabalin JN, McNeal JE, et al. Prostate specific antigen in the diagnosis and
treatment of adeno carcinoma of the prostate. II. Radical prostatectomy treated patients.
J Urol. 1989;141:1076–1083.
10. Lange PH, Ercole CJ, Lightner DJ, et al. The value of serum prostate specific antigen
determinations before and after radical prostatectomy. J Urol. 1989;141:873–879.
11. Killian CS, Yang N, Emrich LJ, et al. Prognostic importance of prostate specific antigen for
monitoring patients with stages B2 to D1 prostate cancer. Cancer Res. 1985;45:886–891.
12. Clinical and Laboratory Standards Institute (formerly NCCLS). Procedures for the Handling
and Processing of Blood Specimens; Approved Guideline - Third Edition. Wayne, PA:
Clinical and Laboratory Standards Institute; 2004. NCCLS Document H18-A3.
13. Carter HB, Albertsen PC, Barry MJ. American Urological Association. Early detection of
prostate cancer: AUA Guideline. J Urol. 2013;190(2):419-426.
14. Mottet N, Bellmunt J, Briers E, et al; European Association of Urology. EAU
Guidelines--Prostate Cancer. Arnhem, The Netherlands: European Association of Urology;
2017. https://uroweb.org/guideline/prostate-cancer
15. Gormley GJ, Stoner E, Bruskewitz RC, et al. The effect of finasteride in men with benign
prostatic hyperplasia. New Eng J Med. 1992;327(17):1185–1191.
16. Graves HCB, Wehner N, and Stamey TA. Comparison of a polyclonal and monoclonal
immunoassay for PSA: need for an international antigen standard.
J Urol. 1990;144:1516–1522.
17. Lilja H, Christensson A, Dahlen U, et al. Prostate-specific antigen in serum occurs
predominantly in complex with alpha-a-antichymotrypsin.
Clin Chem 1991;37(9):1618–1625.
18. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all immunoassays.
Clin Chem. 1988;34:27–33.
19. Clinical and Laboratory Standards Institute (formerly NCCLS). How to Define and
Determine Reference Intervals in the Clinical Laboratory; Approved Guideline -
Second Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2000.
NCCLS Document C28-A2.
20. Clinical and Laboratory Standards Institute (formerly NCCLS). Protocols for Determination
of Limits of Detection and Limits of Quantitation; Approved Guideline–Second Edition.
Wayne, PA: Clinical and Laboratory Standards Institute; 2012. CLSI Document EP17-A2.
21. Clinical and Laboratory Standards Institute (formerly NCCLS). Interference Testing in
Clinical Chemistry; Approved Guideline - Second Edition. Wayne, PA:
Clinical and Laboratory Standards Institute; 2005. NCCLS Document EP7-A2.
22. Clinical and Laboratory Standards Institute (formerly NCCLS). Primary reference
preparations used to standardize calibration of immunochemical assays for serum
prostate specific antigen(PSA); Approved Guideline. Wayne, PA: Clinical and Laboratory
Standards Institute; 1997. NCCLS Document I/LA19-A.

ADVIA Centaur XP, and ADVIA Centaur XPT Systems   10994905_EN Rev. Y, 2019-09
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