ARCH PATHOL LAB MED:丙氨酸转氨酶结果因制造商而异?

2020-06-25 MedSci原创 MedSci原创

疾病指南明确了临床决策的通用谷丙转氨酶(ALT)阈值,但谷丙转氨酶分析仪之间的变异性的影响仍不清楚。本研究比较2012-2017年不同分析仪器的ALT结果。

疾病指南明确了临床决策的通用谷丙转氨酶(ALT)阈值,但谷丙转氨酶分析仪之间的变异性的影响仍不清楚。本研究比较2012-2017年不同分析仪器的ALT结果。

退伍军人健康管理局(VHA)实验室通过5个制造商的分析仪中使用标准化美国病理学家学院(CAP)样品进行外部ALT能力验证测试。在操作分析中,我们评估了223个实验室中80个独立CAP样本的22 950个ALT值。使用混合效应模型,我们估计了分析仪制造商和CAP结果之间的联系,并对制造商、设备和日历年度进行校正。我们对总体均值接近临床指南规定阈值的CAP样本,包括小于50 U/L (n = 10)和小于35 U/L (n = 5)进行亚组分析。

VHA使用了Abbott Laboratories(n = 3175; 14%),Beckman Coulter Diagnostics(n = 8723; 38%),Roche Diagnostics(n = 2595; 11%),Siemens Healthineers USA(n = 5713; 25%)和 Vitros / Ortho Clinical Diagnostics(n = 2744; 12%)分析仪。 CAP样本(n = 80个样本,n = 22×950测试)涵盖了广泛的平均ALT值范围(21–268 U / L)。 读数最高和读数最低的制造商之间的每个样品平均ALT值的平均差异为对于10个平均ALT小于50 U / L的样品,其平均ALT值为15.4 U / L,并总体值且为10.4 U / L (SD = 3.6)(n = 80)。 在线性混合效应模型中,我们发现每年不同制造商之间的ALT值在统计上有显著差异。

本研究发现不同分析仪每年在谷丙转氨酶谱上有统计学和临床意义的差异,包括低于50 U/L和低于35 U/L。应避免将普遍的ALT阈值作为临床行动的触发点,应该先解决分析仪器之间的差异。

原始出处:

Lauren A. Beste, MD, MSc; Michael Icardi, MD;Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012–2017

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