Clinical vs. Regulatory Standards for Laboratory Assays

September 19, 2010

In preparing a standard, some discussion has come up regarding different types of standards. Here is an attempt to clarify.

Clinical standards state what is needed whether or not it can be achieved. For example, two cardiology societies specified troponin I performance (1), yet no assay at the time met this performance (2).

The level of performance required in regulatory standards is based on clinical needs and currently achievable performance. Thus, the troponin assays were all approved assays in spite of not meeting the clinical need standard.

This paradox can perhaps be explained by the following table. Regulatory standards must tradeoff the two risks in the table, whereas the clinical standard does not have the risk in the second row of the table because the assay is already in use.

Risk benefit analysis for approving or rejecting an assay

  Benefit Risk
Approve assay Information helps clinicians Assay errors cause wrong
medical decisions
Reject assay No wrong medical decisions
from assay errors
Lack of information from assay
causes harm


  1. The Joint European Society of Cardiology/American College of Cardiology Committee. Myocardial infarction redefined—a consensus document of the joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol 2000;36:959–69.
  2. Mauro Panteghini Franca Pagani Kiang-Teck J. Yeo Fred S. Apple Robert H. Christenson Francesco Dati Johannes Mair Jan Ravkilde and Alan H.B. Wu on behalf of the Committee on Standardization of Markers of Cardiac Damage of the IFCC. Evaluation of Imprecision for Cardiac Troponin Assays at Low-Range Concentrations Clin Chem 2004;50:327-332.