Precision and accuracy: concepts and assessment by method evaluation testing.

Achieving precision and accuracy in routine clinical analyses is a complex task, requiring the identification, estimation, and elimination of sources of analytical error. This review first considers concepts of precision and accuracy, including discussions of the meaning of measurement process, analytical method, state of statistical control, precision, imprecision, accuracy, inaccuracy, systematic error, overall or total error, true value, traceability, and compatability. These concepts provide the basis upon which the performance of analytical methods can be evaluated. The second part of the review considers how precision and accuracy are assessed by the use of method evaluation experiments. The approach emphasizes the development of an evaluation protocol based on the analytical characteristics which represent the performance of the method. This includes discussions of the familiarization period; testing analytic range and linearity; testing precision by a replication experiment; testing accuracy by recovery, interference, and comparison of methods experiments; the selection of a comparative analytical method; the statistical analysis of method comparison data, including the interpretation of that data; the collaborative testing.