Roche NT-proBNP

The gold standard biomarker in heart failure1
Elecsys® NT-proBNP

Electro-chemiluminescence immunoassay (ECLIA) for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide in human serum and plasma

NT-proBNP is indicated as an aid in the diagnosis of individuals suspected of having congestive heart failure and detection of mild forms of cardiac dysfunction.

The test also aids in the assessment of heart failure severity in patients diagnosed with congestive heart failure. This assay is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure2, and it can also be used for monitoring the treatment in patients with left ventricular dysfunction.

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Elecsys® proBNP II and proBNP II STAT test characteristics2

  • Testing time

    18 minutes or 9 minutes (STAT application)

  • Test principle

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

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

  • 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 801

  • LoB*

    3 pg/mL (specification) on cobas e 801
    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

  • 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

  • Reagent onboard-stability

    8 weeks (or 16 weeks on cobas e 801)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

* LoB: Limit of blank, LoD: Limit of detection, LoQ: Limit of quantitation, CV: Coefficient of variation

Related information

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    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
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