Performance of Kits Used for Clinical Chemical Analysis of Cholesterol

Abstract

SINCE about 1960 convenient "kits" for quantitative determination of blood chemical constituents have become increasingly popular, to the point where several million are sold annually. They are used predominantly in small laboratories that lack the capacity to study product performance in a scientific and systematic fashion. A voluntary program in which the manufacturer provides substantial performance data, which are then checked independently, has been offered since 1964 by the Standards Committee of the College of American Pathologists, but this has been implemented for only a few kits.Because it seemed likely that unevaluated products might contain some incapable of producing . . .