CLSI EP6-A Evaluating the Linearity of Quantitative Measurement Procedures - A Statistical Approach - Approved Guide

Medical Tests

CLSI EP6-A Evaluating the Linearity of Quantitative Measurement Procedures - A Statistical Approach - Approved Guide

This standard provides guidance for characterizing the linearity of a method during a method evaluation. For checking linearity as part of routine quality assurance and for determining and specifying a manufacturer's demand for linear range. The U.S. Food and Drug Administration (FDA) has evaluated and accepted this approved-level consensus guidance for use in meeting a regulatory requirement.

CLSI EP6-A Evaluating the Linearity of Quantitative Measurement Procedures - A Statistical Approach - Approved Guide

This standard provides a method for establishing, verifying or demonstrating the linear range of a quantitative measurement procedure. These methods do not identify significant nonlinearity causes. The method uses an increasing number of samples for more precise linearity studies. Therefore, if an unsuccessful demonstration is evaluated and it is determined that the experiment needs to be repeated, it may be done with more repetitions to cover a smaller interval or with fewer levels.

This protocol is to evaluate linearity as isolated as possible from the precision and accuracy conditions. It was understood that poor precision would hinder an effective assessment of linearity, so a weak repeatability check was included.

In these experiments, samples with matrix suitable for the samples analyzed should be used. This protocol requires laboratories to set targets for nonlinear error. It provides basic concepts for setting such targets, but does not recommend any specific protocols.

EUROLAB assists manufacturers with CLSI EP6-A test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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