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Roche NT-proBNP

The gold standard biomarker in heart failure

Elecsys® NT-proBNP
The Roche Elecsys NT-proBNP assay is an established heart failure biomarker that can aid clinical decision making at every stage of patient care.2

 

Risk assessment

Testing for NT-proBNP in patients with Type 2 diabetes can help identify those at risk of developing heart failure3,4, enabling access to treatments and improving patient outcomes5.

Diagnosis

As an initial test in patients with signs and symptoms of heart failure in both acute or community settings, the Roche NT-proBNP test can rule-out heart failure or identify which patients need to be seen by a specialist6,7, thereby reducing uncessary echocardiograms8 and enabling access to evidence-based treatments to those that need them9. 

The Roche NT-proBNP test has validated age-specific cutoffs for suspected acute heart failure that can improve the specificity and accuracy of an acute heart failure diagnosis10 and are recommended by the European Society of Cardiology and Health Technology Wales as the most clinically and cost-effective strategy to manage suspected heart failure in the acute setting11,12.

In-hospital management

The pre-discharge absolute value of, and relative changes in, Roche NT-proBNP during hospitalisation can provide valuable prognostic information and help identify patients at risk of hospital readmission or death in the following 6 months of admission13,14,15.

Therapy optimisation

NT-proBNP is an essential part of the STRONG-HF rapid up-titration of GDMT strategy that can reduce the risk of re-admission and mortality and improve quality of life. Monitoring NT-proBNP levels inform optimal HF medication adjustments16.

Disease monitoring

Roche NT-proBNP is a powerful prognosticator of patient outcomes, and is superior to BNP as a biomarker in patients treated with an angiotensin receptor-neprilysin inhibitor (ARNi)17, 18. Monitoring NT-proBNP levels over time can provide insight into patients' disease progression1,17.

Instruments that run Roche NT-proBNP

Elecsys® proBNP II and proBNP II STAT test characteristics

  • Testing time

    18 minutes or 9 minutes (STAT application)

  • Test principle

    Two-step sandwich for 18-minute application using cobas® e 402, cobas® e 411, cobas® e 601, cobas® e 602 and cobas® e 801 analysers

    One-step sandwich for STAT application using cobas e 402, cobas e 601, cobas e 602 and cobas e 801 analysers

  • Calibration

    2-Point

     

  • Sample material

    Li heparin, K2‑EDTA and K3‑EDTA plasma

    Plasma tubes containing separating gel can be used.

  • Sample volume

    15 μL on cobas e 411, cobas e 601, cobas e 602
    9 μL on cobas e 402, cobas e 801

  • LoB*

    3 pg/mL (specification) on cobas e 801, cobas e 402
    8 pg/mL (specification) on cobas e 411, cobas e 601, cobas e 602

  • LoD*

    For 18 min and STAT:
    10 pg/mL (specification) on cobas e 411, cobas e 601, cobas e 602
    5 pg/mL (specification) on cobas e 801, cobas e 402

  • LOQ* – LoQ – 20 % CV at ≤50 pg/mL C

    50 pg/mL (specification)

     

     

     

  • Measuring range

    10 - 35,000 pg/mL on cobas e 411, cobas e 601, cobas e 602
    5 – 35,000 pg/mL on cobas e 801, cobas e 402

  • Reagent onboard-stability

    8 weeks (or 16 weeks on cobas e 801, cobas e 402)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     
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Key Areas

Abbreviations

NT-proBNP: N-terminal prohormone of brain natriuretic peptide

 

References

1. McKie PM and Burnett JC. J Am Coll Cardiol. 2016; doi: 10.1016/j.jacc.2016.10.001.

2. Package Insert Elecsys NT-proBNP 09315284190 and 09315284214 v3

3. Ohkuma T, et al. Diabetes Care 2017;40:1203–9

4. Wolsk E, at al. Circulation 2017;137:1560–2

5. Huelsmann M, et al. J Am Coll Cardiol 2013;62:1365–72

6. NICE, [NG106] Chronic heart failure in adults: diagnosis and management. Available from: https://www.nice.org.uk/guidance/ng106 (Last accessed: July 2023)

7. NICE [CG187] Acute heart failure: diagnosis and management. Available from: https://www.nice.org.uk/guidance/cg187 (Last accessed July 2023)

8. Taylor et al. (2017) The REFER (REFer for EchocaRdiogram) study. Southampton (UK): NIHR Journals Library; 2017 Apr. PMID: 28445025.

9. Roalfe et al. (2022) European Heart Journal, Volume 43, Issue 9, 1 Pages 881–891

10. Januzzi et al. (2018). J Am Coll Cardiol 71, 1191-1200

11. Health Technology Wales (HTW) guidance 026 Natriuretic peptides to rule-in and rule-out a diagnosis of acute heart failure in adults in the emergency department

setting (2021). Available at: https://healthtechnology.wales/reports-guidance/natriuretic-peptides-to-rule-in-and-rule-out-a-diagnosis-of-acute-heart-failure/ (Last accessed July 2023)

12. McDonagh et al. (2021) European Heart Journal, 42 (36): 3599–3726

13. Bettencourt (2004). Circulation. 110, 2168-2174

14. Salah et al. (2014). Heart. 100, 115-125

15. Stienen et al. (2015) Eur J Heart Fail. 17, 936-944

16. Mebazaa A, et al. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7. PMID: 36356631.

17. Zile et al. J Am Coll Cardiol, 68 (2016), pp. 2425-2436

18. McMurray, J et al. N Engl J Med, 371 (2014), pp. 993-1004

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