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Elecsys® total PSA and free PSA

Tumor marker tests to support early detection and monitoring of prostate cancer
Elecsys® total PSA and free PSA

Elecsys® total PSA

Elecsys® total PSA is a quantitative in vitro diagnostic test for determination of total (free + complexed) prostate specific antigen (tPSA) in human serum and plasma.1

Prostate cancer is the second most common cancer in men and the 5th leading cause of death from cancer in men.2 Early detection ensures timely management and treatment before prostate cancer can cause potentially fatal conditions.3

Screening approaches have reduced prostate cancer mortality in the USA and in Europe.4,5,6 The most widely used screening tests for prostate cancer are digital rectal examination (DRE) in combination with serum total PSA.7

Guidelines recommend PSA screening in men at higher risk of developing prostate cancer, based on risk factors including age, family history and race.8,9,10,11

Total PSA can also be used to do active surveillance, assess therapy response and for post-treatment follow up.10

The National Comprehensive Cancer Network (NCCN) and the European Association of Urology (EAU) recommend periodic repetition of total PSA tests, with the time interval decided based on the initial PSA level and other risk-factors.10, 12

Elecsys® free PSA

The Elecsys® free PSA is a quantitative in vitro diagnostic test for determination of free PSA (free prostate specific antigen) in human serum and plasma.13

Up to 80% of men with an elevated total PSA level of 4.0–10 ng/mL do not have prostate cancer.14 In men with slightly elevated total PSA (3–10 ng/mL), free PSA helps to discriminate between benign conditions and prostate cancer, and reduces the number of unnecessary biopsies performed.15,16,17

The free/total PSA ratio (% free PSA) detects 95% of prostate cancers and avoids unnecessary biopsy in 20% of men without prostate cancer (using a cut-off value of 25%).18

The Elecsys® free PSA immunoassay should be used only with the Elecsys® total PSA immunoassay to calculate the % fPSA ratio and ratios must be calculated using tPSA and fPSA results both obtained on the same Elecsys® platform.

Benefits

Elecsys® total PSA and free PSA

  • Elecsys® total PSA and free PSA have reliable analytical performance.19
  • With a proven lot-to-lot consistency, Elecsys® total PSA is well suited for prostate cancer monitoring.1

Related Instruments

KONTAKTA OSS

Elecsys® total PSA1

  • Systems

    cobas e 411 analyzer
    cobas e 601, cobas e 602 modules
    cobas e 402 analytical unit, cobas e 801 analytical unit

  • Assay time

    18 min

  • Sample material

    Serum, Li-heparin, K3-EDTA and sodium citrate plasma.

  • Sample volume

    20 μL

  • Detection Limits

    LoB 0.006 ng/mL, LoD 0.010 ng/mL, LoQ 0.014 ng/mL

  • Measuring Range

    0.006 - 100 ng/mL

  • Calibration

    2-point

  • Onboard stability

    cobas e 411 analyzer: 8 weeks
    cobas e 601 / cobas e 602 modules: 4 weeks
    cobas e 801 analytical unit, cobas e 402 analytical unit: 16 weeks

  • Intermediate precision in positive samples*

    cobas e 411 analyzer: CV 2.2 – 11.6 %
    cobas e 601 / cobas e 602 module: CV 1.8 – 6.8 %
    cobas e 801 analytical unit, cobas e 402 analytical unit: CV 1.5 – 5.1 %

  • Repeatability in positive samples*

    cobas e 411 analyzer: CV 1.5 - 6.9 %
    cobas e 601 / cobas e 602 module: CV 0.8 – 4.0 %
    cobas e 801 analytical unit, cobas e 402 analytical unit: CV 0.6 – 4.8 %

  • Traceability

    Standardized against the Stanford Reference Standard/WHO 96/670
    (90 % PSA-ACT + 10 % free PSA)

* Human samples only

Elecsys® free PSA13

  • Systems

    cobas e 411 analyzer
    cobas e 601, cobas e 602 modules
    cobas e 402 analytical unit, cobas e 801 analytical unit

  • Assay time

    18 min

  • Sample material

    Serum, Li-heparin, K3-EDTA and sodium citrate plasma.

  • Sample volume

    20 μL  cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    12 μL cobas e 401 analytical unit, cobas e 801 analytical unit

  • Detection Limits

    LoB 0.01 ng/mL, LoD 0.016 ng/mL, LoQ 0.018 ng/mL

  • Measuring Range

    0.01 - 50 ng/mL

  • Calibration

    2-point

  • Onboard stability

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules: 6 weeks
    cobas e 801 analytical unit, cobas e 402 analytical unit: 16 weeks

  • Intermediate precision in positive samples*

    cobas e 411 analyzer: CV 2.0 – 6.7 %
    cobas e 601 / cobas e 602 module: CV 1.8 – 6.8 %
    cobas e 801 analytical unit, cobas e 402 analytical unit: CV 1.2 – 7.8 %

  • Repeatability in positive samples*

    cobas e 411 analyzer: CV 1.5 – 3.4 %
    cobas e 601 / cobas e 602 module: CV 1.0 – 4.9 %
    cobas e 801 analytical unit, cobas e 402 analytical unit: CV 0.7 – 6.4 %

  • Traceability

    Standardized against the Stanford Reference Standard/WHO 96/668
    (100 % free PSA)

* Human samples only

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    References

     

    1. Elecsys® total PSA Method Sheet for material #08791686190 V2 for cobas e 411, cobas e 601 & cobas e 602 #08791732190 V5 for cobas e 402 & cobas e 801. 
    2. GLOBOCAN 2020. Cancer fact sheets - all cancers. Available at https://gco.iarc.fr/today/online-analysis-multi-bars accessed August 2022.
    3. Esserman L,et al. Rethinking screening for breast cancer and prostate cancer. JAMA. 2009;302:1685-92.
    4. Siegel RL,et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7-33.
    5. Schröder FH, et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009;360:1320-8.
    6. Bray F, et al. Prostate cancer incidence and mortality trends in 37 European countries: an overview. Eur J Cancer. 2010;46:3040-52.
    7. Roobol MJ, Carlsson SV. Risk stratification in prostate cancer screening. Nat Rev Urol. 2013;10:38-48. 
    8. Wolf AM, et al. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin. 2010;60:70-98. 
    9. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer Early Detection Version 1.2022.
    10. EAU EANM ESTRO ESUR ISUP SIOG Guidelines on Prostate Cancer 2022.
    11. Carter HB, et al. Early detection of prostate cancer: AUA Guideline. J Urol. 2013;190:419-26. 
    12. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer Version 4.2022
    13. Elecsys® free PSA Method Sheet for materia t#08828601190 V4 for cobas e 411, cobas e 601 & cobas e 602 #08828610190 V5 for cobas e 402 & cobas e 801.
    14. Catalona WJ, et al. Measurement of prostate-specific antigen in serum as a screening test for prostate cancer. N Engl J Med. 1991;324:1156-61.
    15. Catalona WJ, et al. Prostate cancer detection in men with serum PSA concentrations of 2.6 to 4.0 ng/mL and benign prostate examination. Enhancement of specificity with free PSA measurements. JAMA. 1997;277:1452-5.
    16. Abrahamsson PA, et al. Molecular forms of serum prostate-specific antigen. The clinical value of percent free prostate-specific antigen. Urol Clin North Am. 1997;24:353-65.
    17. Catalona WJ, et al. Evaluation of percentage of free serum prostate-specific antigen to improve specificity of prostate cancer screening. JAMA. 1995;274:1214-20.
    18. Catalona WJ, et al. Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial. JAMA. 1998;279:1542-7. 
    19. Yilmaz H, et al. Percentage of free prostate-specific antigen (PSA) is a useful method in deciding to perform prostate biopsy with higher core numbers in patients with low PSA cut-off values. Kaohsiung J Med Sci. 2015;31:315-9.

     

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