title: Revised calibration of the Reflotron cholesterol assay evaluated.
abstract: We evaluated the Boehringer Mannheim (B.M.) Reflotron Total Cholesterol "dry-chemistry" method after its recalibration in 1987. Reports in the literature up to 1986-1987 of a negative bias (up to -10%) in the method prompted a revision of the factory-set calibration of the Reflotron. For this, B.M. prepared a new set of calibrators with 12 different concentrations of cholesterol. We checked in two ways whether accuracy had been achieved: (a) The values assigned to the calibrators by B.M. were checked with the manual Abell-Kendall Reference Method (MAK) performed in an official Reference Center. These were shown to be correct. (b) Concurrently, a direct comparison was made by analyzing 200 fresh samples of human serum. Reflotron cholesterol values obtained for these samples proved to be accurate, meeting the current World Health Organization/Centers for Disease Control criterion of maximum bias less than or equal to 5%. Orthogonal regression analysis yielded the following correlation: Reflotron = 0.985 MAK + 0.238 mmol/L (y = ax + b). Reflotron mean = 6.26 mmol/L; MAK mean = 6.09 mmol/L. SDa = 0.015 mmol/L; SDb = 0.120 mmol/L, and r = 0.989.
authors: Department of Clinical Chemistry, Academic Hospital Rotterdam, The Netherlands.
authors: G J
authors: GJ
authors: Boerma
authors: I
authors: I
authors: van Gorp
authors: T L
authors: TL
authors: Liem
authors: B
authors: B
authors: Leijnse
authors: J
authors: J
authors: Bellm
authors: C A
authors: CA
authors: Carstensen
mesh_terms: D001322:Autoanalysis / Q000592:standards*; D002138:Calibration; D002784:Cholesterol / Q000097:blood*; D006801:Humans; D011786:Quality Control; D012044:Regression Analysis
chemical_list: D002784:Cholesterol