Assessment of laboratory tests for plasma homocysteine--selected laboratories, July-September 1998.

Cardiovascular disease, including coronary heart disease and stroke, is the leading cause of death in the United States. Elevated plasma homocysteine (Hcy), generally defined as fasting plasma Hcy levels >15 micromol/L, is an independent risk factor for vascular diseases (1,2). It is unknown whether Hcy is a cause of or a marker for atherosclerosis. A recent statement by the Nutrition Committee of the American Heart Association concluded that until results of clinical trials are available, population-wide Hcy screening is not recommended (3). However, Hcy tests are used in the clinical setting and information on interlaboratory variation, on method variation, is limited. To assess the status of interlaboratory and intralaboratory variation for Hcy analysis, CDC conducted a study of selected laboratories during July-September 1998. This report summarizes findings from the study, which indicates a need to improve analytic precision and to decrease analytic differences among laboratories (4).