AL 淀粉样变性中的高灵敏度和常规心肌肌钙蛋白-I 检测方法

IF 1.8 Q3 MEDICAL LABORATORY TECHNOLOGY Journal of Applied Laboratory Medicine Pub Date : 2024-11-04 DOI:10.1093/jalm/jfae111
Maura C Dodge, Tatiana Prokaeva, Lisa Mendelson, Tracy Joshi, Vaishali Sanchorawala, Yachana Kataria
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引用次数: 0

摘要

背景:循环心肌肌钙蛋白-I(cTnI)在生物标志物分期系统中发挥着重要作用,为AL淀粉样变性患者的预后和风险分层提供了重要信息。高灵敏度 cTnI(HS-cTnI)检测方法已被引入临床;然而,有关常规 cTnI 和 HS-cTnI 的一致性以及 HS-cTnI 在心脏生物标志物分期中的效用的数据尚缺:从2022年10月到2023年3月,波士顿大学淀粉样变性中心连续对78名AL淀粉样变性患者进行了前瞻性评估。cTnI使用雅培Architect cTnI化学发光微粒子免疫测定(CMIA)进行测量,HS-cTnI使用雅培Alinity HS-cTnI CMIA测定。通过戴明回归分析和布兰-阿尔特曼分析对测定结果进行比较,并使用两种测定结果对心脏生物标记物进行分期和比较:结果:cTnI 和 HS-cTnI 的中位浓度分别为 13.0 和 7.0 纳克/升。Bland-Altman分析表明,HS-cTnI检测结果存在负偏差(检测结果之间的平均差异百分比:-49.8%),最大差异出现在50纳克/升以下。戴明回归支持这种负偏差(斜率,0.66;截距,-1.9)。使用 HS-cTnI 检测将心脏生物标志物分期从 IIIA 期降至 II 期(n = 3),从 IIIB 期降至 II 期(n = 1):结论:结果显示总体一致;但在低浓度时,HS-cTnI 检测存在负偏差。将传统的 cTnI 阈值 >100 纳克/升应用于基于 HS-cTnI 的波士顿大学心脏分期显示出分期分配降级的趋势。在AL淀粉样变性患者中,HS-cTnI测定在生物标志物分期中的预后作用值得进一步研究。
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High-Sensitivity and Conventional Cardiac Troponin-I Assays in AL Amyloidosis.

Background: Circulating cardiac troponin-I (cTnI) plays a crucial role in biomarker staging systems, offering important information for prognostification and risk stratification of patients with AL amyloidosis. High-sensitivity cTnI (HS-cTnI) assays have been introduced in practice; however, the data on the concordance between conventional and HS-cTnI and the utility of HS-cTnI in cardiac biomarker staging are lacking.

Methods: Seventy-eight consecutive patients with AL amyloidosis who were prospectively evaluated at the Boston University Amyloidosis Center from October 2022 through March 2023 were included. cTnI was measured using the Abbott Architect cTnI chemiluminescent microparticle immunoassay (CMIA) and HS-cTnI using the Abbott Alinity HS-cTnI CMIA assay. Assay results were compared by Deming regression and Bland-Altman analyses, and cardiac biomarker stages were assigned and compared using both assay results.

Results: Median cTnI and HS-cTnI concentrations were 13.0 and 7.0 ng/L, respectively. Bland-Altman analysis demonstrated a negative bias with HS-cTnI results (mean percent difference between assays: -49.8%) and the greatest variance occurring below 50 ng/L. Deming regression supported this negative discordance (slope, 0.66; intercept, -1.9). The use of HS-cTnI assay downgraded cardiac biomarker staging assignments from stage IIIA to stage II (n = 3) and from stage IIIB to stage II (n = 1).

Conclusions: Overall agreement was demonstrated; however, a negative bias for HS-cTnI assay was noted at low concentrations. The application of the conventional cTnI threshold of >100 ng/L to HS-cTnI-based Boston University cardiac staging showed a trend toward downgraded staging assignments. The prognostic utility of HS-cTnI assay in biomarker staging warrants further investigation in patients with AL amyloidosis.

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来源期刊
Journal of Applied Laboratory Medicine
Journal of Applied Laboratory Medicine MEDICAL LABORATORY TECHNOLOGY-
CiteScore
3.70
自引率
5.00%
发文量
137
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