Evaluation of the VITROS 5,1 FS analyzer in a large clinical laboratory: comparison of methods using different specimens and chemistry systems / Evaluation des Systems VITROS 5,1 FS in einem großen klinischen Laboratorium: Methodenvergleiche mit verschiedenen Probenmaterialien und Systemen

Abstract

Abstract The clinical chemical analysis system Vitros 5,1 FS (Ortho Clinical Diagnostics, Neckargemünd, Germany) combines on one platform multilayer film technology with a newly developed technology based on conventional wet chemistry. We report the first extensive evaluation of this novel analyzer, establishing precision data, accuracy, and linearity of MicroSlide technology analytes and analytes using the newly developed MicroTip technology. For comparison, measurements with the analysis systems Beckman-Coulter DXC800 and Immage or Siemens Healthcare Diagnostics Dimension Xpand, and plasma, serum, urine and cerebrospinal fluid (CSF) samples as well as blood from routine operations were employed, respectively. For within-run imprecision, coefficients of variation between 0.2% and 5.5% were calculated. Coefficients of variation for quality control materials from day-to-day ranged from 0.6% to 7.1%. In all examined analytes, except hemoglobin A1c, calculated inaccuracies were within the acceptable ranges of the national directives for quality assurance (RiliBÄK, directives issued by the German Medical Association). Method comparison demonstrated good agreement between MicroSlide assays and wet chemistry methods with correlation coefficients ranging from 0.872 to 0.998. For the MicroTip assays, the calculated correlation coefficients ranged from 0.968 to 0.994. In conclusion, the Vitros 5,1 FS analyzer is a reliable analysis system which can be easily integrated into clinical chemical routine and which can also be applied for analysis of CSF, urine, and blood samples.