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方法研究

根据NCCLS EP09-A2-IR评价两种不同检测系统孕酮检测结果的可比性

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  • (南京医科大学附属苏州医院核医学科,江苏 苏州215002)
魏衍财(1986—),男,初级检验师。Tel:13913191749;E-mail:weiyancai1986@163.com

收稿日期: 2015-01-04

  修回日期: 2015-03-31

  网络出版日期: 2015-09-16

The Comparability Study on the Results of Progesterone Determined by Two Measurement Systems

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  • Department of Nuclear Medicine, Suzhou Hospital Affiliated to Nanjing Medical University, Suzhou 215002, China

Received date: 2015-01-04

  Revised date: 2015-03-31

  Online published: 2015-09-16

摘要

摘要:目的 将化学发光法和电化学发光法孕酮检测结果进行比对,并对结果的一致性进行分析。方法 根据NCCLS EP09-A2-IR文件[1],以BECKMAN DXI800(化学发光法)为比对方法,以ROCHE Cobas e601(电化学发光法)为实验方法,收集40例临床血清标本,分析两种检测方法检测孕酮的相关性及可比性。结果 两种检测系统检测孕酮精密度均较高,且相关性良好(r2=0.971),低水平预期偏倚小于允许偏倚,中高水平预期偏倚大于允许偏倚,结果不具有可比性。结论 两种不同检测系统检测孕酮的重复性及相关性良好,低水平两者检测结果一致性较好,但中高水平两者检测结果差异较大,须对孕酮检测结果进行调整才具有可比性。

本文引用格式

魏衍财,高 菲,朱晨露,朱耿超,杨 辰 . 根据NCCLS EP09-A2-IR评价两种不同检测系统孕酮检测结果的可比性[J]. 标记免疫分析与临床, 2015 , 22(6) : 573 . DOI: 10.11748/bjmy.issn.1006-1703.2015.06.030

Abstract

Abstract: Objective To explore the comparability of results of progesterone detected with chemiluminescence and Electrochemical luminescence method by performing the consistency analysis. Methods According to NCCLS document EP09-A2-IR, the BECKMAN DXI 800 system (chemiluminescence method) was selected as the reference system and the ROCHE Cobas e601 system as the experimental system. The serum progesterone levels in 40 samples were analyzed with two systems, and the correlation and comparability of the two different systems for the detection of progesterone were analyzed. Results The precision and correlation of the two systems for progesterone detection were high and correlated very well (r2=0.971). Low level of expected bias was lower than the allowable bias, the high level of expected bias was higher than the allowable bias, and the results were not comparable. Conclusion The repeatability and correlation of the two systems for progesterone detection are good. The consistency at low level of progesterone between two systems for the detection results is acceptable. However, the consistency at high levels is not acceptable and should be adjusted.
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