Abstract：
OBJECTIVE: To accurately evaluate non-ST-elevated acute cardiac syndrome (NSTE-ACS), the quality of high-sensitive cardiac troponin (hs-cTn) assays is of vital importance. The 2020 revision of the NSTE-ACS guideline includes clinical decision-limits (CDL\'s) to both rule-in and rule-out NSTE-ACS for most commercially available platforms, providing both 0/1 h and 0/2 h delta limits. Our study evaluated whether laboratories are able to meet the analytical performance specifications for imprecision (APS) for hs-cTnT.
METHODS: Results from external quality assurance (EQA) in commutable samples were used to evaluate the current and historic performance of analyzers. The performance of analyzers that either passed or failed to comply with 0/1 h-APS were used on a real-world dataset of first hs-cTnT-values to simulate 10.000 samples of t=0, t=1 and t=2 h values with multiple delta\'s for all relevant CDL\'s. We compared the simulated values to the input values to obtain the percentage of aberrant results simulated.
RESULTS: The majority of analyzers complies with APS for rule-in in 2022 (0/1 h: 90.4 % and 0/2 h: 100 %), compliance for the 0/1 h rule-out is still far from optimal (0/1 h: 30.7 %, 0/2 h: 75.4 %), with improving compliance over the past years (rule-in p=<0.0001, rule-out p=0.011, χ2). Whilst 0/1 h-APS-passing analyzers have a minute risk to falsely rule-out patients whom should be ruled-in (0.0001 %), failing performance increases this risk to 2.1 % upon using 0/1 h CDL\'s. Here, adopting 0/2 h CDL\'s is favorable (0.01 %).
CONCLUSIONS: Laboratories that fail to meet hs-cTnT 0/1 h-APS should improve their performance to the required and achievable level. Until performance is reached clinics should adopt the 0/2 h CDL\'s.
METHODS: Results from external quality assurance (EQA) in commutable samples were used to evaluate the current and historic performance of analyzers. The performance of analyzers that either passed or failed to comply with 0/1 h-APS were used on a real-world dataset of first hs-cTnT-values to simulate 10.000 samples of t=0, t=1 and t=2 h values with multiple delta\'s for all relevant CDL\'s. We compared the simulated values to the input values to obtain the percentage of aberrant results simulated.
RESULTS: The majority of analyzers complies with APS for rule-in in 2022 (0/1 h: 90.4 % and 0/2 h: 100 %), compliance for the 0/1 h rule-out is still far from optimal (0/1 h: 30.7 %, 0/2 h: 75.4 %), with improving compliance over the past years (rule-in p=<0.0001, rule-out p=0.011, χ2). Whilst 0/1 h-APS-passing analyzers have a minute risk to falsely rule-out patients whom should be ruled-in (0.0001 %), failing performance increases this risk to 2.1 % upon using 0/1 h CDL\'s. Here, adopting 0/2 h CDL\'s is favorable (0.01 %).
CONCLUSIONS: Laboratories that fail to meet hs-cTnT 0/1 h-APS should improve their performance to the required and achievable level. Until performance is reached clinics should adopt the 0/2 h CDL\'s.
摘要：
目的：为了准确评估非ST段抬高型急性心脏综合征（NSTE-ACS），高敏心肌肌钙蛋白(hs-cTn)检测的质量至关重要.NSTE-ACS指南的2020年修订版包括对大多数商用平台的规则和排除NSTE-ACS的临床决策限制（CDL）。提供0/1小时和0/2小时的delta限制。我们的研究评估了实验室是否能够满足hs-cTnT的不精确（APS）分析性能规范。
方法：使用可交换样品中外部质量保证（EQA）的结果来评估分析仪的当前和历史性能。通过或不符合0/1h-APS的分析仪的性能被用于第一个hs-cTnT值的真实数据集上，以模拟10.000个t=0、t=1和t=2h值的样本，所有相关CDL具有多个增量。我们将模拟值与输入值进行比较，以获得模拟的异常结果的百分比。
结果：大多数分析仪在2022年符合APS规则（0/1h：90.4％和0/2h：100％），0/1小时排除的合规性仍然远非最佳(0/1小时：30.7%，0/2小时：75.4%），随着过去几年依从性的提高(规则中p=<0.0001，排除中p=0.011，χ2)。虽然0/1h-APS通过分析仪有一分钟的风险错误排除应被排除的患者（0.0001％），在使用0/1小时CDL时，性能失败会将此风险增加到2.1%。这里,采用0/2hCDL是有利的（0.01%）。
结论：未能满足hs-cTnT0/1h-APS的实验室应将其性能提高到所需和可实现的水平。在达到性能之前，诊所应采用0/2hCDL。
方法：使用可交换样品中外部质量保证（EQA）的结果来评估分析仪的当前和历史性能。通过或不符合0/1h-APS的分析仪的性能被用于第一个hs-cTnT值的真实数据集上，以模拟10.000个t=0、t=1和t=2h值的样本，所有相关CDL具有多个增量。我们将模拟值与输入值进行比较，以获得模拟的异常结果的百分比。
结果：大多数分析仪在2022年符合APS规则（0/1h：90.4％和0/2h：100％），0/1小时排除的合规性仍然远非最佳(0/1小时：30.7%，0/2小时：75.4%），随着过去几年依从性的提高(规则中p=<0.0001，排除中p=0.011，χ2)。虽然0/1h-APS通过分析仪有一分钟的风险错误排除应被排除的患者（0.0001％），在使用0/1小时CDL时，性能失败会将此风险增加到2.1%。这里,采用0/2hCDL是有利的（0.01%）。
结论：未能满足hs-cTnT0/1h-APS的实验室应将其性能提高到所需和可实现的水平。在达到性能之前，诊所应采用0/2hCDL。
