Elecsys® BRAHMS Procalcitonin (PCT)

Electrochemiluminescence immunoassay “ECLIA” for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma

Elecsys® BRAHMS Procalcitonin (PCT)
Electrochemiluminescence immunoassay “ECLIA” for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma

The Elecsys® BRAHMS PCT assay can be used to aid in the early detection of clinically relevant bacterial infections. Increased PCT levels are often found in patients suffering from bacterial sepsis, especially severe sepsis and septic shock, and was found to be a reliable indicator of severity and of major complications in acute pancreatitis.

In patients suffering from community-acquired respiratory tract infections or ventilator‑induced pneumonia PCT has been proposed as a guide for the decision of antibiotic treatment necessity and to monitor treatment success.

 

Elecsys® technology

 

ECL (ElectroChemiLuminescence) is Roche’s technology for immunoassay detection. Based on this technology and combined with well-designed, specific and sensitive immunoassays, Elecsys® delivers reliable results. The development of ECL immunoassay is based on the use of a ruthenium-complex and tripropylamine (TPA).

The chemiluminescence reaction for the detection of the reaction complex is initiated by applying a voltage to the sample solution, resulting in a precisely controlled reaction. ECL technology can accommodate many immunoassay principles while providing excellent performance.

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Elecsys® BRAHMS PCT test characteristics

  • Testing time

    18 min

  • Test principle

    One-step sandwich assay

  • Calibration

    2-point

  • Traceability

    BRAHMS PCT LIA

  • Sample material

    Serum and Li-heparin, K2-EDTA and K3-EDTA plasma

  • Sample volume

    30 μL on cobas e 411, cobas e 601, cobas e 602;
    18 μL on cobas e 801

     

  • Limit of Blank*

    0.015 ng/mL

  • Limit of Detection

    0.02 ng/mL

  • Limit of Quantitation*

    0.06 ng/mL

  • Measuring ranges

    0.02 – 100 ng/mL

  • Repeatability**

    cobas e 411: 1.1 – 4.6 %; cobas e 601 / e 602: 1.0 – 6.3 %;
    cobas e 801: 1.3 – 3.3 %

  • Intermediate Precision **

    cobas e 411: 3.3 – 6.9 %; cobas e 601 / e 602: 3.0 – 8.6 %;
    cobas e 801: 2.4 – 3.8 %

  • Reagent Onboard-stability

    4 weeks on cobas e 411, cobas e 601, cobas e 602;
    16 weeks on cobas e 801

  • Expected Values***

    PCT values <0.5 ng/mL represent a low risk of severe sepsis and/or septic shock
    PCT values >2.0 ng/mL represent a high risk of severe sepsis and/or septic shock

* LoB = Limit of Blank; LoD = Limit of Detection; LoQ = Limit of Quantitaion (the lowest analyte concentration that can be reproducibly measured with an intermediate precision CV of ≤ 20 %).

** only for values > 0.1 ng/mL

*** Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges

Source: Procalcitonin Method Sheetdocument