Accuracy in clinical chemistry – who will kiss Sleeping Beauty awake?

Abstract

Triggered by recent criticism from parties outside the clinical chemistry community on poor analytical accuracy of measurement procedures used for evaluating the calcium-parathyroid hormone-vitamin D axis, I argue, in this opinion paper, strongly in favor of prioritizing the establishment of accuracy. I make a proposal on how the clinical chemistry profession could tackle the challenges focused at the conceptual, technical, and organizational level. The profession should "rehearse" the basic concepts of measurement, because they need to be understood before one can look for pragmatic solutions when a purist's approach cannot be realized in a foreseeable time. This is illustrated for the measurement of thyroid stimulating hormone (TSH). To solve problems encountered at the technical level of establishing reference measurement systems, in particular when this is not possible according to the point of view of purism, the profession should have the courage to agree on pragmatic solutions, without neglecting, however, the technical progress. This is exemplified by way of a solution for measurement of FT4 in serum water and TSH. Because the technical question is also inseparably connected to the specification of the analytical quality required for measurements, I propose that the profession sets realistic specifications for calibration tolerance, limits for batch acceptance, linearity, etc. Last but not least, I call upon organizing and implementing the accuracy process with utmost care, i.e., in a concerted action with all parties involved in patient care. The driving force towards accuracy should come from the test developers, while the lead should be taken by the clinical chemistry community, itself being guided by the clinical professions.