Clinical vs. regulatory specifications

Our paper on error grids has been published online. As is often the case, there is another opinion paper that comments on our paper. One of the comments is that our classification of specifications as either clinical or regulatory is equivocal and potentially dangerous. Maybe our writing was not clear enough. We are just stating the way things are.

Thus, some specifications (clinical specifications) state what is needed medically, whether it can be achieved or not. It is hard to find such specifications and in our paper we cited a troponin specification, because it was proposed by cardiologists and it was not achieved at the time.

Other specifications (regulatory specifications) state limits which are currently being achieved. Regulators must do this because if they raised the bar above the currently achieved performance, the assay would not be available which could cause more harm than allowing it to be used.

Thus, our paper just states the difference between these specifications and adding clarity is not equivocal. It is what it is.

What I object to is that some specifications such as the ISO glucose meter specification 15197 try to mix up these two specification types by saying that this ISO (regulatory) specification is based on medical need. Again, regulatory specifications are based on current assay performance and the fact that withholding the assay from use would be more harmful than allowing the assay to be used.

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