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Elecsys® S100

Electro-chemiluminescence immunoassay (ECLIA) for the in vitro quantitative determination of S100 (S100 A1B and S100 BB) in human serum

Elecsys S100

Electro-chemiluminescence immunoassay (ECLIA) for the in vitro quantitative determination of S100 (S100 A1B and S100 BB) in human serum

This assay can be used

  • To aid in the management of patients suffering from malignant melanoma (Elecsys S100 assay is not suitable for the diagnosis of malignant melanoma).
  • To aid in the management of patients after potential brain injury in conjunction with clinical information and imaging techniques

 

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® S100 test characteristics

  • Testing time

    18 min

  • Test principle

    One-step sandwich assay

  • Calibration

    2-point

  • Traceability

    This method has been standardized against weighed-out S100 β/β protein

  • Sample material

    Serum

  • Sample volume

    20 μL on cobas e 411, cobas e 601, cobas e 602;
    12 μL on cobas e 402, cobas e 801

  • Limit of Blank*

    0.005 μg/L

  • Limit of Detection*

    0.015 μg/L

  • Limit of Quantitation*

    0.02 μg/L

  • Measuring ranges**

    0.005 - 39 μg/L (cobas e 411, e 601 / e 602)
    0.015 - 30 μg/L (cobas e 402, cobas e 801)

  • Repeatability

    cobas e 411: 1.4 - 7.1 %; cobas e 601 / e 602: 1.3 - 2.6 %;
    cobas e 402, cobas e 801: 2.0 - 4.1%

  • Intermediate Precision

    cobas e 411: 2.2 - 7.9 %; cobas e 601 / e 602: 2.7 - 4.3 %;
    cobas e 402, cobas e 801: 4.1 -7.8 %

  • Reagent Onboard-stability

    8 weeks on cobas e 411, 8 weeks on cobas e 601, cobas e 602
    16 weeks on cobas e 402, cobas e 801

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

**defined by the lower detection limit and the maximum of the master curve

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    Source: S100 Method Sheet 08817324500V5.0 and Elecsys S100 Method Sheet 03175243190V13.0