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, 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

Total PSA can also be used to do active surveillance, assess therapy response and for post-treatment follow up.11

The National Comprehensive Cancer Network (NCCN) and the European Association of Urology suggest testing every 2–4 years when PSA >1 ng/mL, with repeat testing up to 8 years later when PSA levels are <1 ng/mL.9,10

 

Elecsys® free PSA

Elecsys® free PSA, a prostate specific antigen (free PSA) for the quantitative determination of free PSA in human serum and plasma.12

Up to 80% of men with an elevated total PSA level of 4.0–10 ng/mL do not have prostate cancer.13 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.14,15,16

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%).17

Benefits

Elecsys® total PSA and free PSA

  • Elecsys® total PSA and free PSA have highly reliable technical performance.18
  • With a proven lot-to-lot consistency, Elecsys® total PSA is well suited for prostate cancer monitoring.1

Elecsys® total PSA1

  • Assay time

    18 min

  • Traceability

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

  • Sample material

    Serum, Li-heparin, K3-EDTA and sodium citrate plasma.
    When sodium citrate is used, the results must be corrected by +10%

  • Sample volume

    20 μL

  • Detection Limits

    LoB 0.006 ng/mL, LoD 0.010 ng/mL, LoQ 0.014 ng/mL (cobas e 411 analyzer, cobas e 601, cobas e 602 module)

    LoB 0.006 ng/mL, LoD 0.014 ng/mL, LoQ 0.030 ng/mL (cobas e 801 module)

  • Measuring Range

    0.006 - 100 ng/mL (cobas e 411 analyzer, cobas e 601, cobas e 602 modules)

    0.006 - 100 ng/mL (cobas e 801 module)

Elecsys® free PSA12

  • Assay time

    18 min

  • Traceability

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

  • Sample material

    Serum, Li-heparin, K3-EDTA and sodium citrate plasma.
    When sodium citrate is used, the results must be corrected by +10%

  • Sample volume

    20 μL

  • Detection Limits

    LoB 0.01 ng/mL, LoD 0.016 ng/mL, LoQ 0.018 ng/mL (cobas e 411 analyzer, cobas e 601, cobas e 602 module)

    LoB 0.01 ng/mL, LoD 0.016 ng/mL, LoQ 0.018 ng/mL (cobas e 801 module)

  • Measuring Range

    0.01 - 50 ng/mL (cobas e 411 analzyer, cobas e 601, cobas e 602 module)

    0.01 - 50 ng/mL (cobas e 801 module)

References

 

  1. Elecsys total PSA method sheet.
  2. GLOBOCAN 2018, https://gco.iarc.fr/today/online-analysis-multi-bars, Accessed: September 2020
  3. Esserman, L., Shieh, Y. & Thompson, I. Rethinking screening for breast cancer and prostate cancer. JAMA 302, 1685–1692 (2009).
  4. Siegel, R., Naishadham, D. & Jemal, A. Cancer statistics, 2012. CA Cancer J. Clin. 62, 10–29 (2012).
  5. Schröder, M.D. et al; N Engl J Med 2009;360:1320–8.
  6. Bray, F., Lortet-Tieulent, J., Ferlay, J., Forman, D. & Auvinen, A. Prostate cancer incidence and mortality trends in 37 European countries: an overview. Eur. J. Cancer 46, 3040–3052 (2010).
  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 Guideline in Oncology, Prostate Cancer Early Detection, NCCN.org. Version 2.2019, May 2019
  10. Mottet N, et al. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol 2017;71:618–29.
  11. Sanda et al.; Clinically localized prostate cancer: AUA/ASTRO/SUO guideline, 2017
  12. Elecsys free PSA method sheet
  13. 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.
  14. 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.
  15. Abrahamsson PA, et al. Molecular forms of serum prostatespecific antigen. The clinical value of percent free prostatespecific antigen. Urol Clin North Am 1997;24:353–65.
  16. 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.
  17. Catalona WJ, et al. Use of the percentage of free prostatespecific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial. JAMA 1998;279:1542–7.
  18. 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.