Evaluation of VITROS(R) 5,1 FS Automated Chemistry Analyzer / 임상검사와정도관리

ABSTRACT

BACKGROUND: VITROS(R) 5,1 FS (Ortho-Clinical Diagnostics, NY, USA) is a newly developed, fully automated analyzer that uses the dry slide type technology to process routine chemistry items, electrolytes, therapeutic drug monitoring and immunity items. We evaluated the usefulness of the VITROS(R) 5,1 FS in the aspect of precision, linearity, recovery rates and comparison. METHODS: We evaluated the analytical performance of the VITROS(R) 5,1 FS for sodium, potassium, chloride, total CO2, BUN, creatinine, glucose, amylase, total protein, albumin, ALT, AST, ALP, GGT, total bilirubin, unconjugated bilirubin, calcium and phosphorus. Commercialized quality control material, Performance Verifiers (Ortho-Clinical Diagnostics, NY, USA), chemTRAK(R).H (Medical Analysis Systems, California, USA) and patient' sera for evaluation of precision, linearity, recovery rates and comparison were used. MODULAR Systems (Roche Diagnostics, Switzerland) and CX3 (Beckman Coulter, California, USA) were used as a comparative analyzer to evaluate comparison study. RESULTS: Within-run and within-day coefficients of variation (CVs) of all items were below 5%. Between-day and total CVs were less than 5% in almost all items except of total CO2, amylase, ALT, AST, total bilirubin, unconjugated bilirubin and phosphorus. The linearities were statistically acceptable (R2>0.99) for all items (P<0.001). The recovery rates for all items were in the range of 96.20 to 111.45%. The comparison study indicated good correlation between VITROS(R) 5,1 FS and MODULAR Systems or CX3, and correlation coefficients of all items were above 0.975 except sodium (0.971) (P<0.01). CONCLUSIONS: VITROS(R) 5,1 FS showed satisfactory precision, linearity, recovery rates and comparison. Because it has features of one system with many capabilities, we recommend that VITROS(R) 5,1 FS would be used for the emergency laboratories in general hospitals with many examinations or in medium-sized laboratories with relatively small numbers of cases.