孕酮免疫分析缺乏地屈孕酮的分析干扰

T. Eggersmann, A. Wolthuis, P. van Amsterdam, G. Griesinger
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引用次数: 0

摘要

黄体酮是一种性类固醇,在多种临床情况下通过免疫分析法测定血清中黄体酮的含量。类固醇激素免疫测定的一个潜在限制是由与测定的靶类固醇结构相似的化合物引起的干扰。地屈孕酮(DYD)是一种口服活性孕酮立体异构体,用于妇女健康的各种适应症。在此,我们报道了一项系统的体外研究,研究了DYD及其活性代谢物20α-二氢氢孕酮(DHD)在七种广泛使用的、市售的孕酮检测中的潜在干扰。方法对常规人血浆样本进行匿名化处理,并将其汇总,形成P4高、P4中、P4低三个浓度等级。每个P4血浆样品(6 - 7ml)在高、中、“无”浓度下用DYD/DHD加标,分成0.5 mL等分。在荷兰医学实验室质量评估基金会的荷兰内分泌实验室诊断工作组内,七个不同的实验室使用常规孕酮测定(分别为六种不同的免疫测定和一种液相色谱-串联质谱测定)对盲法等分进行了分析。结果中、高浓度P4样品的回收率(加DYD/DHD样品的P4结果除以未加DYD/DHD样品的P4结果× 100)在±10%的范围内,而低浓度P4样品的回收率变化较大。然而,后者可归因于低P4浓度下的高方法间和方法内变异性。结论:本研究未发现常规黄体酮检测中DYD/DHD有任何相关干扰。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Lack of analytical interference of dydrogesterone in progesterone immunoassays
Abstract Objectives Progesterone, a sex steroid, is measured in serum by immunoassay in a variety of clinical contexts. One potential limitation of steroid hormone immunoassays is interference caused by compounds with structural similarity to the target steroid of the assay. Dydrogesterone (DYD), an orally active stereoisomer of progesterone, is used for various indications in women’s health. Herein, we report a systematic in vitro investigation of potential interference of DYD and its active metabolite 20α-dihydrodydrogesterone (DHD) in seven widely used, commercially available progesterone assays. Methods Routine human plasma samples were anonymized and pooled to create three graded concentration levels of progesterone (P4 high, P4 medium, P4 low). Each pooled P4 plasma sample (6–7 mL) was spiked at high, medium, and “none” concentration with DYD/DHD and was divided into 0.5 mL aliquots. The blinded aliquots were analyzed by seven different laboratories with their routine progesterone assay (six different immunoassays and one liquid chromatography–tandem mass spectrometry assay, respectively) within the Dutch working group on endocrine laboratory diagnostics of the Dutch Foundation for Quality Assessments in Medical Laboratories. Results The sample recovery rate (P4 result obtained for sample spiked with DYD/DHD, divided by the result obtained for the corresponding sample with no DYD/DHD × 100) was within a ±10% window for the medium and high P4 concentrations, but more variable for the low P4 samples. The latter is, however, attributable to high inter- and intra-method variability at low P4 concentrations. Conclusions This study does not indicate any relevant interference of DYD/DHD within routinely used progesterone assays.
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