CLSI EP14 Guide
Evaluation of Commutability of Processed Samples Guide
This document is your essential guide for evaluating the commutability of processed samples such as those used in external quality assessment, proficiency testing, and quality control. It helps laboratories identify if these samples behave differently when compared to native patient samples, ensuring that your quantitative measurements are accurate and reliable. This document is perfect for medical laboratories looking to maintain the highest standards in demonstrating commutability during the validation or verification phases of the Test Life Phases Model.
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{{FormatPrice(nonMemberPrice)}} List PriceCLSI EP14-Ed4-G provides guidance on evaluating the commutability of processed samples, such as external quality assessment, proficiency testing, or quality control (QC) samples, by determining whether they cause biases different from unprocessed patient samples when 2 quantitative measurement procedures are compared. Processed samples can also be human samples that are modified in a way that might change their measurement characteristics. In all cases, CLSI EP14-Ed4-G can be useful for both developers and medical laboratory end users, providing information on the commutability of processed materials and explaining how a processed sample’s matrix can affect some measurand values and their interpretation (referred to as “matrix effects”).
CLSI EP14-Ed4-G is not intended for use with in vitro diagnostic manufacturer–specific calibrators. The assessment methods described in CLSI EP14-Ed4-G should not be used in product regulatory submissions from such manufacturers.
CLSI EP14-Ed4-G is not intended to be used to evaluate specimen type differences, such as serum vs plasma comparisons. Methods for evaluation of specimen equivalence are described in CLSI EP35.
This document is available in electronic format only.
CLSI EP14-Ed4-G provides guidance on evaluating the commutability of processed samples, such as external quality assessment, proficiency testing, or quality control (QC) samples, by determining whether they cause biases different from unprocessed patient samples when 2 quantitative measurement procedures are compared. Processed samples can also be human samples that are modified in a way that might change their measurement characteristics. In all cases, CLSI EP14-Ed4-G can be useful for both developers and medical laboratory end users, providing information on the commutability of processed materials and explaining how a processed sample’s matrix can affect some measurand values and their interpretation (referred to as “matrix effects”).
CLSI EP14-Ed4-G is not intended for use with in vitro diagnostic manufacturer–specific calibrators. The assessment methods described in CLSI EP14-Ed4-G should not be used in product regulatory submissions from such manufacturers.
CLSI EP14-Ed4-G is not intended to be used to evaluate specimen type differences, such as serum vs plasma comparisons. Methods for evaluation of specimen equivalence are described in CLSI EP35.
This document is available in electronic format only.