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.

Prostate cancer is the second most common cancer in men and the leading death cause from cancer in men.¹ Early detection ensures timely management and treatment before prostate cancer can cause potentially fatal conditions.²

Screening approaches have reduced prostate cancer mortality in the USA and in Europe.^3,4,5 The most widely used screening tests for prostate cancer are digital rectal examination (DRE) in combination with serum total PSA.⁶

Guidelines recommend PSA screening in men at higher risk of developing prostate cancer, based on risk factors including age, family history and race.^7,8,9

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 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.^8,9

Elecsys^® free PSA

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

Up to 80% of men with an elevated total PSA level of 4.0–10 ng/mL do not have prostate cancer.¹¹In 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.^12,13,14

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%).¹⁵

Benefits

Elecsys^® total PSA and free PSA

Elecsys^®total PSA and free PSA have highly reliable technical performance.¹⁶
With a proven lot-to-lot consistency, Elecsys^® total PSA test is well suited for prostate cancer monitoring.¹⁷

Elecsys® total PSA and free PSA

Elecsys^® total PSA

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 Limit

0.002 ng/mL (cobas e 411 analyzer)
0.003 ng/mL (cobas e 601 module)
0.014 ng/mL (cobas e 801 module)
Measuring Range

0.002 – 100 ng/mL (cobas e 411 analyzer)
0.003 – 100 ng/mL (cobas e 601 module)

Elecsys^® free PSA

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 Limit

≤ 0.01 ng/mL
0.014 ng/mL (cobas e 801 module)
Measuring Range

0.01 – 50 ng/mL

References

GLOBOCAN 2012. Estimated cancer incidence, mortality and prevalence worldwide in 2012. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Last accessed: 16 March 2017.
Esserman, L., Shieh, Y. & Thompson, I. Rethinking screening for breast cancer and prostate cancer. JAMA 302, 1685–1692 (2009).
Siegel, R., Naishadham, D. & Jemal, A. Cancer statistics, 2012. CA Cancer J. Clin. 62, 10–29 (2012).
Schröder, M.D. et al; N Engl J Med 2009;360:1320–8.
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).
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 Guidelines. Prostate cancer early detection. Version 2.2016. J Natl Compr Canc Netw 2016;14:509–19.
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.
AUA Guidelines for the management of clinically localized prostate cancer: 2017 update version.
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 prostatespecific antigen. The clinical value of percent free prostatespecific 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 prostatespecific 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.
Elecsys total PSA method sheet.