Abstract
BACKGROUND: Because our laboratory had used the Ciba Corning 200 series blood-gas analyzers for a number of years, we were asked to partici-pate in the evaluation of a premarket unit of the Model 840 analyzer (C840). DESCRIPTION OF DEVICE: The C840 is a bench-top instrument that com-bines a menu-driven user interface with an automated sampler and integrates software for data management and system diagnostics. EVALUATION METH-ODS: We compared the performance of the C840 to a laboratory-based Ciba Corning 278 (C278), analyzing a total of 325 blood samples. We also evalu-ated the software for routine laboratory applications. EVALUATION RE-SULTS: The bias and imprecision (± 2 SD) between the C840 and C278 was calculated for pH (+0.004 ± 0.014 pH units), PCO2 (+1.8 ± 3.3 torr), and PO2 (+0.01 ±9.0 torr for all PO2 ranges; -0.17 ± 4.8 torr for PO2 < 150 torr). CON-CLUSIONS: We conclude that the analytical performance of the C840 is com-parable to the C278, and its data storage and interface capabilities should help laboratories meet CLIA-88 requirements.
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