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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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    Elecsys® Rubella IgG
    Elecsys® HSV-2 IgG
    Elecsys® HSV-2 IgG
    Elecsys® HSV-1 IgG
    Elecsys® HSV-1 IgG
    Elecsys® CMV IgG
    Elecsys® CMV IgG
    Elecsys® CMV IgM
    Elecsys® CMV IgM
    Influenza A/B
    cobas® Influenza A/B & RSV UC Test
    ctDNA collection tubes
    Cell-Free DNA Collection Tube
    Elecsys® sFlt-1/PlGF (Preeclampsia)
    Elecsys® sFlt-1/PlGF (Preeclampsia)
    Clinical Chemistry - Calibrators and Controls
    Clinical Chemistry - Calibrators and Controls
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    cobas® DNA Sample Preparation Kit
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    cobas® MTB-RIF/INH
    Elecsys pack
    Elecsys® EBV panel
    Elecsys® Tg II
    Elecsys® Tg II
    cobas® TV/MG box
    cobas® ️TV/MG
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    cobas® cfDNA Sample Preparation Kit
    Elecsys® Toxo IgM
    Elecsys® Toxo IgM
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    cobas® CT/NG
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    cobas® BKV
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    cobas® MTB
    cobas® SARS-CoV-2 test kit
    cobas® SARS-CoV-2 Test
    Elecsys® HE4 - Human epididymal protein 4
    Elecsys® HE4 - Human epididymal protein 4
    Elecsys® CA 125 II
    Elecsys® CA 125 II
    sars cov 2 rapid antigen test nasal 2.0
    SARS-CoV-2 Rapid Antigen Test 2.0 Nasal
    Tina-quant® HbA1c Gen. 3
    Tina-quant® HbA1c Gen. 3
    cobas c packs
    Clinical Chemistry - Substrates Portfolio
    sars cov 2 rapid antigen test 2.0
    SARS-CoV-2 Rapid Antigen Test 2.0
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    cobas® CMV
    Elecsys Zika IgG
    Elecsys® Zika IgG
    GenMark ePlex RP2 panel
    ePlex® Respiratory Pathogen Panel 2
    Elecsys® HCV Duo
    Elecsys® HCV Duo
    cobas e pack
    Elecsys® Anti-HBc II
    cobas e pack
    Elecsys® Anti-HBc IgM
    Dual Target HIV
    Dual Target HIV-1 Assay
    Product image for cobas® 4800 CT/NG Test
    cobas® 4800 CT/NG Test
    Elecsys pack
    Elecsys® SARS-CoV-2 Antigen
    cobas® 4800 BRAD V600 Mutation Test
    cobas® 4800 BRAF V600 Mutation Test
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    cobas® HEV
    Image of cobas® DPX assay for the detection of parvovirus B19 and HAV in donated blood
    cobas® DPX
    LightMix<sup>®</sup> Modular Assays
    LightMix® Modular Assays
    Elecsys pack
    Elecsys® Anti-HAV II
    VENTANA FOLR1 (FOLR-2.1) RxDx Assay (US FDA Approved)
    VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
    Elecsys pack
    Elecsys® Anti-SARS-CoV-2
    Elecsys IL-6
    Elecsys® IL-6
    cobas® Plasma Separation Card
    cobas® Plasma Separation Card
    HPV mRNA Probes
    HPV mRNA Probes
    RMD_cobas_EGFR_Mutation_Test_v2
    cobas® EGFR Mutation Test v2
    Elecsys Reagent Pack
    Elecsys® HBsAg II Auto Confirm
    Product image for cobas® Influenza A/B and RSV Assay
    cobas® Influenza A/B & RSV Assay
    cobas® SARS-CoV-2 Qualitative Test
    cobas® SARS-CoV-2 Qualitative Test
    Product image for cobas® HIV-1/HIV-2 Qualitative Test
    cobas® HIV-1/HIV-2 Qualitative Test
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    cobas® HIV-1 Test
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    cobas® HBV RNA (RUO)
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    cobas® HCV Test
    cobas®️ Factor II and Factor V Test
    cobas® ️Factor II and Factor V Test
    CINtec Histology slide
    CINtec® Histology
    CINtec PLUS slide
    CINtec® PLUS Cytology
    SARS-CoV-2 Rapid Antigen Test
    SARS-CoV-2 Rapid Antigen Test
    cobas® HBV Test
    cobas® HBV Test
    VENTANA HER2 Dual ISH DNA Probe Cocktail Assay CDx icon
    VENTANA HER2 Dual ISH DNA Probe Cocktail assay (CE IVD)
    SARS-CoV-2 Antigen Self Test Nasal för självtestning
    SARS-CoV-2 Antigen Self Test Nasal
    SARS_kit
    cobas® SARS-CoV-2 & Influenza A/B Test
    VENTANA MMR RxDx panel icon
    VENTANA MMR RxDx Panel (CE IVD)
    PD-L1 SP142 Assay
    VENTANA PD-L1 (SP142) Assay (CE IVD)
    Lung cancer IHC assay panel
    Lung cancer IHC panel
    Reagent Pack
    Cardiac C-Reactive Protein High Sensitive
    Roche Troponin T-high sensitive (cTnT-hs)
    Elecsys® Troponin T-high sensitive
    Elecsys® Phospho-Tau (181P) CSF
    Elecsys® Phospho-Tau (181P) CSF
    Roche breast cancer IHC Assay panel icon
    Breast cancer IHC/ISH portfolio
    SARS-CoV-2 Rapid Antigen Test Nasal
    SARS-CoV-2 Rapid Antigen Test Nasal
    Elecsys S100
    Elecsys® S100
    Elecsys® NT-proBNP
    Roche NT-proBNP
    Hematopathology assay
    Hematopathology cancer IHC/ISH panel
    Elecsys® β-Amyloid(1-42) CSF II
    Elecsys® β-Amyloid(1-42) CSF II
    Roche Pathway HER2 4B5 assay slide and therapy image
    PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody
    Elecsys® AMH (Anti-Mullerian Hormone)
    Elecsys® AMH (Anti-Mullerian Hormone)
    Elecsys® Total -Tau CSF
    Elecsys® Total -Tau CSF
    Icon
    Elecsys® GAAD
    Elecsys Reagent Pack
    Elecsys® Anti-p53
    Elecsys Reagent Pack
    Elecsys® AFP
    Parainfluenza
    cobas® Paraflu 1-4 UC Test
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    cobas® HSV 1 and 2 Test
    VENTANA anti-ALK (D5F3), lung carcinoma
    VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (CE IVD)
    cobas® HPV Test image
    cobas® HPV
    Dermatopathology IHC assay panel icon
    Dermatopathology IHC panel