Verification of Methods and Instruments

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Abstract

Analytical methods are often developed at one site and transferred to other sites for routine use. Increasingly, the method development is made by manufacturers of instruments and reagents. Regulatory agencies have ruled that the responsibility for the performance of in vitro diagnostic devices (IVDs) in the laboratories mainly should lie with the manufacturers. However, laboratories must verify that the claimed performance can be reproduced. There are several standards and recommendations pertaining to such verifications. Laboratories need to have access to verification procedures that combine cost-effectiveness and user-friendliness with sufficient statistical power to accept or reject the claims of the manufacturers. In the present report, simplified procedures are described to estimate the bias and imprecision supported by readily accessible software. The procedures specify the necessary measurements, accommodate a standardized input, perform all necessary calculations, and display graphical and numerical results.

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