Wayne, Pennsylvania, USA—August 2015—CLSI recently released new and revised standards on method evaluation. A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures (EP19-Ed2) uses the “measurement procedure lifecycle” framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufacturers and clinical laboratories, ie, for laboratory-developed tests. Harmonization of Symbology and Equations (EP36-Ed1) provides a standardized symbology for use throughout CLSI documents. Use of these standardized symbols is expected to be of great benefit to the CLSI readership, volunteers participating in CLSI committees, and the scientific community in general.
EP19 is intended to serve as a reference guide for the use of CLSI documents in method evaluations, especially for persons developing or implementing new clinical laboratory tests. This redesigned document is not an evaluation protocol in the traditional sense. Rather, it is a report that references existing CLSI method evaluation documents, explaining which CLSI documents are useful for validating newly developed tests, and which are useful when implementing new tests in the laboratory. EP19 is intended for use by clinical laboratory professionals, manufacturers, and governmental agencies.
This document provides guidance for manufacturers developing new tests and for laboratories developing their own laboratory-developed tests. EP19 provides a roadmap to help the laboratory establish each new test’s performance characteristics. Laboratories using EP19 will learn which CLSI documents to turn to for understanding a test’s linearity interval, precision, stability, quality control, and more. Also, when implementing a new test, EP19 will help the laboratory understand which CLSI documents contain procedures for verifying the manufacturer’s performance claims.
EP36 provides a list of the most common statistical symbols and formulas to describe testing procedures and statistical analyses. The International Organization for Standardization documents as well as the terminology, symbols, and equations used in all of the CLSI evaluation protocols documents were considered in the development of this report. Symbols were grouped based on the evaluation approach for which they applied. The intended users of this document are CLSI volunteers and staff involved in developing standards and related products. It is intended that future CLSI documents will converge to a more standardized symbolism and notation by taking into account the recommendations made in this document.
These documents can be downloaded for free on the CLSI Shop at shop.clsi.org/method-evaluation-documents/.