Created to help your lab staff properly implement the procedures in our Evaluation Protocol (EP) standards, CLSI’s new implementation guides can help your laboratory verify test precision, accuracy, and other important performance characteristics. The guides are intended to be used by the laboratory scientists who perform verification testing.

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Explore CLSI’s New Implementation Guides

3/16/2022

Created to help your lab staff properly implement the procedures in our Evaluation Protocol (EP) standards, CLSI’s new implementation guides can help your laboratory verify test precision, accuracy, and other important performance characteristics. The guides are intended to be used by the laboratory scientists who perform verification testing. They describe the procedures necessary for a medical laboratory to verify a manufacturer’s or a laboratory-developed test’s performance claims.

Simplified protocols are provided with instructions for the entire testing process, including gathering the appropriate samples, testing the samples, and analyzing the data. Each Implementation Guide is accompanied by an Excel workbook, for use when calculations need to be performed. Users can simply enter the requested information and enter the data to obtain verification results.

These implementation guides and workbooks are not meant to replace the respective CLSI EP documents with which they correspond, but are intended to be used alongside the EP documents as an aid for the verification testing procedure.

Paula Ladwig, MS, MT(ASCP), Chairholder of the Expert Panel on Evaluation Protocols said, "CLSI Implementation Guides are the newest tool for the end user clinical laboratory for verification during the Test Life Phases Model. These implementation guides describe the minimum procedures necessary for verifying the specified performance characteristic. The study design is taken from the main guidance document but presented in a simplified step-by-step manner for the end user to follow. A workbook is provided that allows the end user to enter their data and be provided with guidance of acceptability of the data. CSLI Implementation Guides can be a great tool in standardization across laboratories."

Find all Implementation Guides here.

 

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