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一种用于评估前列腺特异性抗原(PSA)检测性能的新数学方法。

A new mathematical procedure for the assessment of test performance of PSA assays.

作者信息

Hänseler E, Keller H

机构信息

Institute of Clinical Chemistry, University Hospital Zürich, Switzerland.

出版信息

Scand J Clin Lab Invest Suppl. 1995;221:52-6. doi: 10.3109/00365519509090564.

DOI:10.3109/00365519509090564
PMID:7544485
Abstract

A new procedure has been worked out and adapted on microsoft Excel that allows to calculate from one set of e.g. 100 triplicate measurements the critical limit, the limit of detection and the power of definition. The limit of detection is defined as the analyte concentration which can be differentiated from the blank with a confidence of > or = 95%. The power of definition defines the number of values that can be differentiated in a certain interval with a predefined probability (e.g. > or = 95%). The lower limit of quantification is obtained graphically from the precision profile as the intersection of a line, representing the maximum acceptable CV, with the upper edge of the confidence interval.

摘要

已经制定了一种新程序,并在微软Excel上进行了适配,该程序允许从一组例如100次重复测量数据中计算出临界限度、检测限和定义能力。检测限定义为能够以大于或等于95%的置信度与空白区分开的分析物浓度。定义能力定义了在特定区间内能够以预定义概率(例如大于或等于95%)区分的值的数量。定量下限从精密度分布图中通过图形方式获得,即代表最大可接受变异系数的直线与置信区间上边缘的交点。

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