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We read with concern the recent paper by Fallest-Strobl, Olafsdottir, Wiebe, and Westgard (1) in which the authors state, “… the NCEP recommendations fail to adequately consider the quality control requirements necessary to detect medically important systematic errors.” We also note that Westgard, Petersen, and Wiebe (2) published a similar paper in 1991 questioning the adequacy of the NCEP recommendations for total cholesterol. We appreciate the importance of the issues addressed in these two papers and find no fault in the majority of the derivations. We do notice, however, that the authors did not address the conditional nature of their calculations. That is, the OPSpecs charts do not take into account the fact that a patient result will only be reported when the quality control (QC) run associated with the patient specimen is considered to be in control. Thus, the OPSpecs charts relate to the conditional probability that a measured patient result will exceed a specified limit, not to the joint probability of patient misclassification. For misclassification to occur, the measured patient result must not only exceed the specified limit, but the QC procedure must also fail to indicate an out-of-control condition. Without taking into account the probability that the QC procedure will fail to detect an out-of-control condition, the authors do not accomplish their stated intention to evaluate the NCEP recommendations with regard to “quality control procedures that are necessary to detect unstable operation” (2). Incorporating QC performance into the OPSpecs charts requires inclusion of the probability that a patient result will be reported on the basis of the QC outcome of the analytic run in which the patient specimen was measured.To illustrate our point, consider the intended 0.95 probability of correct classification chosen by the authors. This conditional probability does not reflect the overall likelihood of correct … bAuthor for correspondence.

Adequacy of NCEP Recommendations for Total Cholesterol, Triglycerides, HDLC, and LDLC Measurements