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增强型雅培AxSYM心肌肌钙蛋白I试剂在存在嗜异性抗体患者中的性能表现。

Performance of the enhanced Abbott AxSYM cardiac troponin I reagent in patients with heterophilic antibodies.

作者信息

Yeo K T, Storm C A, Li Y, Jayne J E, Brough T, Quinn-Hall K S, Fitzmaurice T F

机构信息

Department of Pathology, Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive, Lebanon, NH 03756, USA.

出版信息

Clin Chim Acta. 2000 Feb 25;292(1-2):13-23. doi: 10.1016/s0009-8981(99)00260-0.

DOI:10.1016/s0009-8981(99)00260-0
PMID:10686273
Abstract

The presence of heterophilic antibodies in the serum of a small subpopulation of individuals continues to cause false results for modern-day immunoassays. In order to determine the frequency of heterophilic antibody (HA)-related false positives within our population of positive cardiac troponin I (cTnI) patients, we assayed 200 samples using the original in-house cTnI assay (Abbott AxSYM) and the Bayer ACS:180 cTnI, which we had previously observed to be more effective at blocking HA interference. Four samples were identified as false positives based on discordant results between the two assays, as well as the correction of the false positives by treatment of the samples with heterophilic antibody blocking reagent (HBR). An 'enhanced' version of the AxSYM cTnI reagent was designed to greatly reduce or eliminate HA interference, and has now replaced the original reagents. The present study shows that the enhanced reagent significantly reduced or eliminated much of the HA interference. Comparative studies between the enhanced cTnI reagent and the original Abbott AxSYM cTnI reagent showed excellent correlation and equivalent diagnostic concordance, when HA samples were excluded from the analysis.

摘要

一小部分个体血清中嗜异性抗体的存在,持续导致现代免疫测定出现假结果。为了确定在我们的心脏肌钙蛋白I(cTnI)阳性患者群体中嗜异性抗体(HA)相关假阳性的频率,我们使用原始的内部cTnI测定法(雅培AxSYM)和拜耳ACS:180 cTnI对200份样本进行了检测,我们之前观察到后者在阻断HA干扰方面更有效。基于两种测定结果的不一致,以及用嗜异性抗体阻断试剂(HBR)处理样本后对假阳性的校正,鉴定出4份样本为假阳性。AxSYM cTnI试剂的“增强”版本旨在大幅减少或消除HA干扰,现已取代原始试剂。本研究表明,增强试剂显著减少或消除了大部分HA干扰。当从分析中排除HA样本时,增强型cTnI试剂与原始雅培AxSYM cTnI试剂之间的比较研究显示出极好的相关性和等效的诊断一致性。

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Life (Basel). 2022 Jul 24;12(8):1114. doi: 10.3390/life12081114.
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Recovery of spiked troponin I in four routine assays.四种常规检测方法中肌钙蛋白I加标回收率
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A non-ischaemic cause of elevated troponin.肌钙蛋白升高的非缺血性原因。
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Nanoparticle-based bio-barcode assay redefines "undetectable" PSA and biochemical recurrence after radical prostatectomy.基于纳米颗粒的生物条形码分析重新定义了根治性前列腺切除术后“不可检测”的前列腺特异性抗原和生化复发。
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Interferences in immunoassay.免疫测定中的干扰因素。
Clin Biochem Rev. 2004 May;25(2):105-20.
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Beckman Access versus the Bayer ACS:180 and the Abbott AxSYM cardiac Troponin-I real-time immunoassays: an observational prospective study.贝克曼Access与拜耳ACS:180及雅培AxSYM心肌肌钙蛋白I实时免疫测定法的比较:一项前瞻性观察研究。
BMC Emerg Med. 2004 Jul 13;4(1):2. doi: 10.1186/1471-227X-4-2.