Laboratory Evaluation of Cobas(R) Integra Automated Chemistry Analyzer / 대한임상병리학회지

ABSTRACT

BACKGROUND: The Cobas(R) Integra is a new automated chemistry analyzer with continuous and random-access features for routine chemistries, specific proteins, electrolytes, therapeutic drugs and drugs of abuse. The system maintains 68 test-specific reagent cassettes on board and have test principles of absorbance photometry, immunoturbidometry, fluorescence polarization and ISE measurements. We evaluated the usefulness of Cobas(R) Integra in the aspect of accuracy, precision, linearity, comparison study, test speed and general performance. METHODS: We evaluated the analytical performance of the Cobas(R) Integra for T. bilirubin, CRP, BUN, creatinine, sodium, potassium, chloride, valproic acid, phenytoin and carbamazepine according to NCCLS guidelines (EP5-T2, EP6-P, EP9-T and GP10-T). RESULTS: In accuracy study, error ranges(%) of most test items, except sodium and chloride, were within analytic goals. In within-run and between-run precision study, Coefficient of variation (CV, %) of most items, except sodium, were lower than limits suggested by College of American Pathologists Survey 1991. The linearities were maintained well in the range of medically significant levels and were statistically acceptable (p<0.001). The comparison study for most items, except sodium and chloride, indicated good correlation with Hitachi 747 and TDx FLx(TM) and correlation coefficients (r) were above 0.98. Throughput was about 450 tests/hr. CONCLUSIONS: Cobas(R) Integra showed satisfactory accuracy, precision, linearity, good correlation with other analyzers and high throughput. So, we concluded that Cobas(R) integra is highly suitable for not only routine use but also emergency tests in medium to large-sized hospitals because of its high productivity and reliability.