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
* Human samples only
* Human samples only
References
- 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.
- GLOBOCAN 2020. Cancer fact sheets - all cancers. Available at https://gco.iarc.fr/today/online-analysis-multi-bars accessed August 2022.
- Esserman L,et al. Rethinking screening for breast cancer and prostate cancer. JAMA. 2009;302:1685-92.
- Siegel RL,et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72:7-33.
- Schröder FH, et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009;360:1320-8.
- Bray F, et al. Prostate cancer incidence and mortality trends in 37 European countries: an overview. Eur J Cancer. 2010;46:3040-52.
- Roobol MJ, Carlsson SV. Risk stratification in prostate cancer screening. Nat Rev Urol. 2013;10:38-48.
- 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.
- NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer Early Detection Version 1.2022.
- EAU EANM ESTRO ESUR ISUP SIOG Guidelines on Prostate Cancer 2022.
- Carter HB, et al. Early detection of prostate cancer: AUA Guideline. J Urol. 2013;190:419-26.
- NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer Version 4.2022
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.