确定临床上可接受的心脏热素在决策值的分析变化
John W Pickering1,2, Peter Kavsak3, Robert H Christenson4
1Department of Emergency Medicine, Emergency Care Foundation, Christchurch Hospital, Christchurch, New Zealand.
Clinical chemistry
|May 7, 2024
概括
高灵敏度心脏托罗宁测定中的分析变化对肌动脉梗塞风险分层的灵敏度的影响最小. 效率略有降低,特别是与三角洲值,但安全指标仍然强大.
科学领域:
- 临床化学 临床化学
- 心血管诊断心血管诊断服务
- 生物标志物检测验证验证
背景情况:
- 心肌梗塞 (MI) 风险分层依赖于高灵敏性心脏热素 (hs-cTn) 值.
- 在hs-cTn试验中的分析变异需要对其对临床决策的影响进行评估.
研究的目的:
- 量化分析变异对hs-cTn试验针对MI风险分层的灵敏度和有效性的影响.
- 为 hs-cTn 试验建立最低分析变异标准.
主要方法:
- 从Abbott hs-cTnI和Roche hs-cTnT测定中模拟了大型数据集 (1,000,000名患者).
- 热宁度根据临界值和上限 (URL) 周围的绝对 (0.5-3 ng/L) 和相对 (2-20%) 变化而变化.
主要成果:
- 在低风险值时对灵敏度的影响微不足道 (<0.3%),分析变化越来越大.
- 低风险患者的比例下降 (罗氏:30%至29%;阿博特:53%至44%).
- 在URL的灵敏度没有变化;正预测值 (PPV) 降低了<3%. 增加的三角洲值提高了灵敏度,但降低了有效性.
结论:
- 分析变化高达3 ng/L极少影响MI风险分层的敏感性,但稍微降低了有效性.
- 网址的变化对安全性和有效性指标的影响最小.
- 德尔塔值的变化不会影响敏感性,但会降低有效性.
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