Abstract

The evaluation of new laboratory instruments as potential replacements for existing instruments occurs frequently in most clinical laboratories. Typically, considerable attention is paid to the evaluation of the analytical performance characteristics (eg, precision, accuracy, reportable range, reference interval) of the methods for the various analytes that can be quantified using these instruments, some or no attention is paid to the clinical performance characteristics [eg, diagnostic accuracy (sensitivity and specificity), negative and positive predictive value] of these methods, and little attention may be paid to the operational performance characteristics (eg, acceptable specimen types and volume requirements, completeness of test menu, maximum run size) of the new instrument compared to the existing or competitor instruments. The rationale for this difference in attention paid by laboratory professionals to the aforementioned performance characteristics of laboratory methods/instruments is most likely

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