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  • 1.  IVD - Linearity

    This message was posted by a user wishing to remain anonymous
    Posted 17-Feb-2022 16:00
    This message was posted by a user wishing to remain anonymous

    Dear IVD Developers,

    Seeking your input on linearity studies: 

    does specimen type require the use of actual sample (to be used with the IVD in future), or a saline solution containing the analyte(s) is sufficient enough. 

    Thank you for your advice.
    Best regards.



  • 2.  RE: IVD - Linearity

    Posted 18-Feb-2022 10:52
    Dear Ano,

    As for all analytical validation studies for IVD, it is important to use samples that are as representative as possible of the samples used in the real analysis, nevertheless these may be solutions containing the analyte to be determined from which dilutions are made, or they may be samples of matrix equivalent to that of the sample to be determined, overloaded or depleted with the compound to be measured.
    In all cases it is necessary to ensure that the samples used respond like real samples.

    Best regards

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