Laboratory Medicine Department, La Paz University Hospital, Madrid, Spain.
Analytical Quality Commission, Spanish Society of Laboratory Medicine (SEQCML), Spain.
Clin Chem. 2021 Jan 8;67(1):256-264. doi: 10.1093/clinchem/hvaa261.
Many studies have assessed the biological variation (BV) of cardiac-specific troponins (cTn), reporting widely varying within-subject BV (CVI) estimates. The aim of this study was to provide meta-analysis-derived BV estimates for troponin I (cTnI) and troponin T (cTnT) for different sampling intervals and states of health.
Relevant studies were identified by a systematic literature search. Studies were classified according to their methodological quality by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Meta-analyses of BIVAC-compliant studies were performed after stratification by cTn isoform, exclusion of results below the limit of detection, states of health, and sampling interval to deliver reference change values (RCV), index of individuality (II) and analytical performance specifications (APS) for these settings.
Sixteen and 15 studies were identified for cTnI and cTnT, respectively, out of which 6 received a BIVAC grade A. Five studies had applied contemporary cTnI assays, but none contemporary cTnT. High-sensitivity (hs-) cTnI and cTnT delivered similar estimates in all settings. Long-term CVI estimates (15.1; 11.3%) derived from healthy individuals were higher than short-term (4.3%; 5.3%) for hs-cTnI and hs-cTnT, respectively, although confidence intervals overlapped. Estimates derived from diseased subjects were similar to estimates in healthy individuals for all settings.
This study provides robust estimates for hs-cTnI and hs-cTnT applicable for different clinical settings and states of health, allowing for the use of RCV both to aid in the diagnosis of myocardial injury and for prognosis. BV-based APS appear too strict for some currently available technologies.
许多研究评估了心脏特异性肌钙蛋白（cTn）的生物学变异（BV），报告了广泛变化的个体内 BV（CVI）估计值。本研究的目的是为不同采样间隔和健康状态的肌钙蛋白 I（cTnI）和肌钙蛋白 T（cTnT）提供基于荟萃分析的 BV 估计值。
通过系统文献检索确定相关研究。根据生物学变异数据关键评估清单（BIVAC）的方法学质量对研究进行分类。对符合 BIVAC 标准的研究进行分层荟萃分析，分层依据为 cTn 同工型、排除检测下限以下的结果、健康状态和采样间隔，以提供这些设置的参考变化值（RCV）、个体指数（II）和分析性能规格（APS）。
共确定了 16 项 cTnI 研究和 15 项 cTnT 研究，其中 6 项获得了 BIVAC 等级 A。五项研究应用了现代 cTnI 检测方法，但没有现代 cTnT 检测方法。高敏（hs）cTnI 和 cTnT 在所有设置中提供了相似的估计值。来自健康个体的长期 CVI 估计值（15.1%；11.3%）高于 hs-cTnI 和 hs-cTnT 的短期（4.3%；5.3%），尽管置信区间重叠。来自患病个体的估计值与所有设置中的健康个体的估计值相似。
本研究为 hs-cTnI 和 hs-cTnT 提供了适用于不同临床设置和健康状态的可靠估计值，允许使用 RCV 辅助心肌损伤的诊断和预后。基于 BV 的 APS 对于某些现有技术来说似乎过于严格。
