• Olink’s custom panel offering

    Olink aims to provide a solution that covers the entire journey from early protein biomarker discovery, through to the validation and implementation of clinically relevant protein signatures. While our standard offer of carefully designed 92-plex panels provides an ideal discovery platform, our custom panel development enables customers to take the next important steps to protein biomarker validation and implementation.

    Taking protein biomarker profiles from initial discovery to clinical implementation, from standard multiplex panels to custom development

     

    Once you have established a set of biomarkers defining your protein profile of interest, we can work with you to design and validate a smaller panel of up to 21 proteins. Moreover, you can choose between relative quantification (i.e. NPX readout as for standard panels) or absolute quantification, as well as select one of two validation options, depending on your requirements.  An overview of the Olink custom panel offering is shown below:

    Olink custom panels: Up to 21 proteins measured simultaneously with just 1 µL sample with relative or absolute quantification and a choice of 2 validation levels.

     

    Product offer descriptions

    Offer 1: Custom panel with relative quantification, panel evaluation

    • Development and optimization of a custom panel using existing PEA assays (including optimization of probes and required sample dilution)
    • Relative quantification (NPX)
    • Analytical sensitivity (LOD, LLOQ, ULOQ, range)
    • Biological range (analysis of up to 72 samples)
    • Scalability (correlation between NPX values from analyses using the 92-plex panels and data from the custom panel for up to 72 samples )
    • Precision (intra-assay and inter-assay CV assessment using control samples included on each plate: 4 plates/2 detections)

    Offer 2: Custom panel with absolute quantification, panel evaluation

    • Development and optimization of a custom panel using existing PEA assays (including optimization of probes and required sample dilution)
    • Development of calibrators (high, mid and low)
    • Absolute quantification
    • Analytical sensitivity (LOD, LLOQ, ULOQ, range)
    • Biological range and linearity (analysis of up to 72 samples, 2-fold dilutions in sample diluent)
    • Scalability (correlation between NPX values from analyses using the 92-plex panels and data from the custom panel for up to 72 samples)
    • Precision (intra-assay and inter-assay CV assessment using control samples included on each plate: 6 plates/3 detections)

    Offer 3: Custom panel with absolute quantification, fit-for-purpose validation

    • Development and optimization of a custom panel using existing PEA assays (including optimization of probes and required sample dilution)
    • Development of calibrators (high, mid and low)
    • Absolute quantification
    • Analytical sensitivity (LOD, LLOQ, ULOQ, range)
    • Biological range (analysis of up to 144 samples)
    • Linearity (dilutions performed in a true matrix condition using native samples, also include 2-fold dilutions in sample diluent)
    • Scalability (correlation between NPX values from analyses using the 92-plex panels and data from the custom panel for up to 144 samples)
    • Cross-talk
    • Cross-reactivity (analysis of similar/related proteins when readily available)
    • Precision (intra-assay and inter-assay CV assessment using control samples included on each plate: 8 plates/4 detections)

    While Olink already applies thorough validation processes to all of its standard panels, even more stringent validation is included in this offer to ensure that the panel is fit-for-purpose for future clinical utility (e.g. early phase clinical trials). The figure below overviews the specific validation steps taken, and you can read more about this by reading our white paper on this subject.

    Overview of the technical evaluations involved in fit-for-purpose validation