Comparison of several regression procedures for method comparison studies and determination of sample sizes. Application of linear regression procedures for method comparison studies in Clinical Chemistry, Part II.

In part I of this series (H. Passing & W. Bablok (1983), J. Clin. Chem. Clin. Biochem. 21, 709-720) we described a new biometrical procedure for the evaluation of method comparison studies. In part II we now discuss its properties and compare them with those of other established procedures by means of a simulation study. We demonstrate that the reliability of the results not only depends on the sample size but also on the sampling distribution, the precision of the methods, and the concentration range covered by the samples. Linear regression and principal component procedures are either inadequate or not as reliable as our new procedure. The appropriate sample size is discussed and recommendations are given.