Reflotron performance in a community screening program: results of the Massachusetts Model Systems for Blood Cholesterol Screening Project.

We evaluated the precision, accuracy, and durability of the Reflotron portable analyzer as part of the National Heart, Lung, and Blood Institute's Model Systems for Blood Cholesterol Screening Program. We conducted screenings in a wide variety of settings in four Massachusetts communities over a 16-month period. Fingerstick samples from 10,428 individuals were tested on the Reflotron at the screening sites. For comparison, we drew venous samples from 972 participants and analyzed them in a reference laboratory, which had met the requirements of the Centers for Disease Control's Lipid Standardization Program. All four Reflotrons tested met the 1988 guidelines for precision and accuracy established by the Laboratory Standardization Panel (LSP) of the National Cholesterol Education Program (NCEP). None of the analyzers consistently met the 1992 LSP standards for precision, although two met the 1992 standards for accuracy. More than 40% of Reflotron values differed from the reference laboratory values by more than 5%. As a consequence, more than 16% of individuals were misclassified in terms of the NCEP risk category into which their Reflotron readings fell. All four instruments malfunctioned at some point during the project, precluding their further usage. We recommend improvements in the precision, accuracy, and durability of this analyzer.