CLSI EP05 ja Plus
Evaluation of Precision of Quantitative Measurement Procedures (Japanese Translation)
CLSI EP05 provides guidance for evaluating the precision performance of quantitative measurement procedures. It is intended for manufacturers of quantitative measurement procedures and for laboratories that develop or modify such procedures.
This document package includes the Japanese and English language editions of CLSI EP05-A3 (2014) and the more recently published CLSI EP05-Ed4 (2025), which reflects current CLSI guidance and should be referenced as the definitive source document. There is not currently a Japanese translation available for this newer 4th edition, however users should consult the latest edition as the current standard.
The Japanese translation was developed under the supervision of the Japanese Committee for Clinical Laboratory Standards (JCCLS) to support the adoption of this standard in Japan.
CLSI wishes to acknowledge the contributions of the volunteers from the JCCLS Terminology Committee and the CLSI Translation Working Group of the Japan Association of Clinical Reagents Industries (JACRI), the JCCLS and JACRI leadership, and the member organizations that contributed to this translation. You can learn more about this collaboration in this news story.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute document EP05-A3—Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition provides guidance for evaluating the precision of in vitro diagnostic quantitative measurement experimental designs and includes recommendations for establishing precision performance. Included are guidelines for duration, experimental designs, materials, data analysis, summarization, and interpretation— techniques adaptable for a wide spectrum of measurands and system complexity. These guidelines are intended for manufacturers or developers of clinical laboratory measurement procedures, and for users who wish to determine their own performance characteristics. A balance is created in the document between complexity of design and analysis, and simplicity of operation.
This document provides guidance for studies intended to establish the within-site precision performance characteristics of quantitative measurement procedures used in clinical laboratories, and also for studies addressing site-to-site variability. Multiple experimental protocols are described, along with considerations on how to select and optimize the protocol(s) best suited for a specific measurement procedure (or “assay”) and its intended use.
This document is available in electronic format only.
Clinical and Laboratory Standards Institute document EP05-A3—Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition provides guidance for evaluating the precision of in vitro diagnostic quantitative measurement experimental designs and includes recommendations for establishing precision performance. Included are guidelines for duration, experimental designs, materials, data analysis, summarization, and interpretation— techniques adaptable for a wide spectrum of measurands and system complexity. These guidelines are intended for manufacturers or developers of clinical laboratory measurement procedures, and for users who wish to determine their own performance characteristics. A balance is created in the document between complexity of design and analysis, and simplicity of operation.
This document provides guidance for studies intended to establish the within-site precision performance characteristics of quantitative measurement procedures used in clinical laboratories, and also for studies addressing site-to-site variability. Multiple experimental protocols are described, along with considerations on how to select and optimize the protocol(s) best suited for a specific measurement procedure (or “assay”) and its intended use.
This document is available in electronic format only.