Elecsys^® total PSA and free PSA

Tumor marker tests to support early detection and monitoring of prostate cancer

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 5^th 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

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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Elecsys^® total PSA and free PSA