多项式回归与加权最小二乘回归分析在分析量程验证中的比较

Tae-Dong Jeong, Soo-Kyung Kim, Sollip Kim, C. Lim, J. Chung
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引用次数: 1

摘要

摘要目的近期,临床与实验室标准协会(CLSI)将线性评价方案从EP6-A修订为EP6-ED2,线性评价数据的统计解释方法由多项式回归改为加权最小二乘线性回归(WLS)。我们根据现有和先前的线性度评价指南对分析测量范围(AMR)验证结果进行了分析和比较。方法采用5个样品,在3个不同的实验室进行2个重复的临床化学试验AMR的验证。通过多项式回归分析和WLS方法对每个实验室的相同评价数据进行分析后,比较结果,以确定五种样品浓度之间是否验证线性。此外,比较WLS对线性偏差的90%置信区间是否包含在允许线性偏差(ADL)中。结果经多项式回归分析,3个实验室化学项目的线性关系为42.3 ~ 56.8%。用WLS对同一数据进行分析,当5个样本的线性偏差均在ADL标准内时,检验项目的线性度为63.5-78.3%,当所有线性偏差的90%置信区间与ADL重叠时,检验项目的线性度为78.8-91.3%。结论根据新修订的CLSI文件EP6-ED2,采用WLS方法解释AMR验证数据,可减少实验室工作量,提高实验室工作效率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison between polynomial regression and weighted least squares regression analysis for verification of analytical measurement range
Abstract Objectives Recently, the linearity evaluation protocol by the Clinical & Laboratory Standards Institute (CLSI) has been revised from EP6-A to EP6-ED2, with the statistical method of interpreting linearity evaluation data being changed from polynomial regression to weighted least squares linear regression (WLS). We analyzed and compared the analytical measurement range (AMR) verification results according to the present and prior linearity evaluation guidelines. Methods The verification of AMR of clinical chemistry tests was performed using five samples with two replicates in three different laboratories. After analyzing the same evaluation data in each laboratory by the polynomial regression analysis and WLS methods, results were compared to determine whether linearity was verified across the five sample concentrations. In addition, whether the 90% confidence interval of deviation from linearity by WLS was included in the allowable deviation from linearity (ADL) was compared. Results A linearity of 42.3–56.8% of the chemistry items was verified by polynomial regression analysis in three laboratories. For analysis of the same data by WLS, a linearity of 63.5–78.3% of the test items was verified where the deviation from linearity of all five samples was within the ADL criteria, and the cases where the 90% confidence interval of all deviation from linearity overlapped the ADL was 78.8–91.3%. Conclusions Interpreting AMR verification data by the WLS method according to the newly revised CLSI document EP6-ED2 could reduce laboratory workload, enabling efficient laboratory practice.
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