State of the art in trueness and interlaboratory harmonization for 10 analytes in general clinical chemistry.

Context: Harmonization and standardization of results among different clinical laboratories is necessary for clinical practice guidelines to be established.

Objective: To evaluate the state of the art in measuring 10 routine chemistry analytes.

Design: A specimen prepared as off-the-clot pooled sera and 4 conventionally prepared specimens were sent to participants in the College of American Pathologists Chemistry Survey.

Wisconsin State Laboratory of Hygiene's role in clinical laboratory improvement.

The clinical laboratory at the beginning of the 21st century is a highly automated, multi-faceted entity, capable of turning out complex test results on a variety of samples in a relatively short period of time. These test results are used by physicians to diagnose illness, establish treatment strategies, and monitor therapies for patients. They must be of the highest quality and reliability to insure that the course of action taken by the health care provider will lead to the best possible outcome for the patient.

Point: status of lipid and lipoprotein standardization.

Cholesterol and triglyceride standardization procedures have been used extensively and continuously since the 1950s. Definitive and Reference Methods, as well as primary and secondary standards, have been developed and maintained as the basis for evaluating the accuracy of results by various methods in many laboratories. But, although standardization efforts for apolipoprotein A-I and B measurements have been reported in detail in the scientific literature, much less has been reported in the area of total and lipoprotein cholesterol and triglyceride standardization efforts.

Newborn screening for cystic fibrosis in Wisconsin: comparison of biochemical and molecular methods.

Objectives: To evaluate neonatal screening for cystic fibrosis (CF), including study of the screening procedures and characteristics of false-positive infants, over the past 10 years in Wisconsin. An important objective evolving from the original design has been to compare use of a single-tier immunoreactive trypsinogen (IRT) screening method with that of a two-tier method using IRT and analyses of samples for the most common cystic fibrosis transmembrane regulator (CFTR) (DeltaF508) mutation. We also examined the benefit of including up to 10 additional CFTR mutations in the screening protocol.