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免疫测定中的不精密度概况。一项采用重采样技术的研究。

The imprecision profile in immunoassay. A study using a resampling technique.

作者信息

Chiecchio A, Giglioli F, Malvano R, Ringhini R, Manzone P, Bo A

机构信息

Servizio di Fisica Sanitaria, Ospedale Mauriziano, Turin, Italy.

出版信息

J Immunol Methods. 1992 Mar 4;147(2):211-6. doi: 10.1016/s0022-1759(12)80010-x.

DOI:10.1016/s0022-1759(12)80010-x
PMID:1548403
Abstract

A resampling ('bootstrap') technique was applied to assess the reliability of the calculated imprecision profile (IP), as obtained from the dose/response curve and the response/error relationship (RER) using the cumulative data relative to two assays, i.e. a T4 radioimmunoassay (RIA) and a TSH immunofluorometric assay (IFMA), both run in duplicate. Mean values and the related uncertainty of the estimated dose errors were compared for different RER fitting conditions and different sizes of the duplicate response sets. The following observations were made: (a) compared to the maximum-likelihood procedure, the least-square fit proved to be unsuitable for estimating the parameters in the general RER equation variance(R) = aRb (where R indicates the response), (b) the simplifying assumption of a within-method constancy of the exponent in the RER equation, while acceptable for the T4 RIA, did not hold in the case of the TSH IFMA implying a much wider response range, (c) for both assays, response sets of ca. 100 duplicates were apparently compatible with an acceptable definition of the IP (+/- 10 to +/- 20% uncertainty).

摘要

采用重采样(“自助法”)技术来评估计算得到的不精密度曲线(IP)的可靠性,该曲线是通过剂量/反应曲线以及反应/误差关系(RER),利用来自两种分析方法(即甲状腺素放射免疫分析(RIA)和促甲状腺激素免疫荧光分析(IFMA))的累积数据获得的,两种分析均重复进行。针对不同的RER拟合条件以及重复反应集的不同规模,比较了估计剂量误差的平均值及相关不确定度。得出以下观察结果:(a) 与最大似然法相比,最小二乘法拟合被证明不适用于估计一般RER方程方差(R)=aRb(其中R表示反应)中的参数;(b) RER方程中指数在方法内恒定这一简化假设,虽然对甲状腺素RIA是可接受的,但在促甲状腺激素IFMA的情况下不成立,这意味着反应范围要宽得多;(c) 对于两种分析,约100次重复的反应集显然与IP的可接受定义(不确定度为±10%至±20%)相符。

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