Reliability of the Reflotron in the determination of cholesterol

Abstract

Measurements of total cholesterol in the field by means of the Reflotron dry-chemistry system (capillary blood) were compared to total cholesterol obtained by a standardized conventional wet-chemistry method in a clinico-chemical laboratory (serum). A total of 1200 people participated in the study. Two identical Reflotron machines were used. In the first period of the study an excellent agreement was found between Reflotron measurements of a reference serum provided by the manufacturer (mean, 4.99 mmol/l; CV, 1.8%) and the stated value (4.97 mmol/l). In the rest of the study higher values and greater variation were found with the Reflotron (mean, 5.32 mmol/l; CV 5.2%). Clearly the Reflotron measurements in the latter period of study were not reliable. In the period with stable instruments most of the values obtained at the two Reflotron machines differed from each other by less than 10%, with a mean difference of 0.08 mmol/l. Reflotron (both machines) and wet-chemistry measurements agreed well for the first 500 participants in the study (mean difference, Reflotron-wet-chemistry, -0.008 mmol/l; 95% confidence interval, -0.035 to 0.019 mmol/l; correlation, 0.967). In this period most Reflotron values differed from wet-chemistry values by less than 9% below to 9% above. With the next 200 participants the Reflotron gave on average slightly higher values than wet-chemistry measurements. The coefficients of variation for measurement variation were higher for Reflotron that for wet-chemistry even in the period with stable instruments. In all parts of the study period a lower HDL-cholesterol level was associated with larger differences between total cholesterol determined by Reflotron and wet-chemistry.