Measurement Procedure Comparison and Bias Estimation Using Patient Samples
Also Known As:
SKU195893847
Published by
Clinical and Laboratory Standards Institute
CLSI
Publication Date2018
Pages CountPages116
This guideline provides recommendations for designing an experiment and selecting methods to quantify systematic measurement error (bias or difference) between measurement procedures based on comparing patient samples. It provides both difference plot and regression procedures to determine the relationship between two measurement procedures either across their measuring intervals or at selected concentrations. Intended users of this guideline are manufacturers of in vitro diagnostic (IVD) reagents—which includes those who create laboratory-developed tests—as well as regulatory authorities and medical laboratory personnel.
This guideline is for use with measurement procedures that provide quantitative numerical results. This guideline is not intended for use with ordinal IVD examinations, commonly referred to as qualitative procedures (see CLSI document EP121). This guideline is not intended to provide information on evaluation of random error (see CLSI documents EP052 and EP153) or to determine the total error inherent in a comparison of measurement procedures (see CLSI document EP214). It is not intended to measure the variability of multiple replicates collected during the measurement of a sample, nor is it intended to measure the bias of individual measurements such as those resulting from sample interference (as covered in CLSI document EP075).
This guideline is for use with measurement procedures that provide quantitative numerical results. This guideline is not intended for use with ordinal IVD examinations, commonly referred to as qualitative procedures (see CLSI document EP121). This guideline is not intended to provide information on evaluation of random error (see CLSI documents EP052 and EP153) or to determine the total error inherent in a comparison of measurement procedures (see CLSI document EP214). It is not intended to measure the variability of multiple replicates collected during the measurement of a sample, nor is it intended to measure the bias of individual measurements such as those resulting from sample interference (as covered in CLSI document EP075).
Details
| Descriptors | Alternative regression methods, bias, evaluation protocol, experimental design, linear regression, measurement procedure comparison, outliers, quality control, residuals |
| Language(s) | English |
| File Size | 5.2 MB |
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