CLSI EP21 PDF
CLSIEP21provides developers and endusers with an understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. An experimental protocol and analytical method are provided to estimate TAE based on a comparison of results between the candidate method and a comparator method using patient specimens. Each paired difference is compared with a pre-established specification for acceptability, ie, the allowable total error (ATE). Guidance for determining the ATE is provided in CLSIEP46.
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