Department of Pathology, Keck School of Medicine, University of Southern California, 1200 N. State Street, Clinic Tower A7E113, Los Angeles, CA 90033, USA.
Department of Pathology, Los Angeles County + University of Southern California (LAC + USC) Medical Center, Los Angeles, CA, USA, Phone: +323-409-7060, Fax: +323-441-8193.
Clin Chem Lab Med. 2019 Aug 27;57(9):1414-1421. doi: 10.1515/cclm-2018-1362.
Background Procalcitonin (PCT) is a biomarker for systemic bacterial infections and may aid in decision making for antimicrobial stewardship. Numerous PCT assays are available on common clinical immunoassay platforms. However, questions remain about the harmonization of these assays and whether the same clinical decision points may be used with all methods. Methods Thirty-seven remnant patient serum samples were analyzed across four different PCT assays: Abbott ARCHITECT i2000, bioMérieux MINI VIDAS, Roche Elecsys cobas e 411, and BRAHMS KRYPTOR. Regression analysis was performed, and correlation was assessed at common clinical decision points for antimicrobial therapy: 0.10, 0.25, and 0.50 μg/L. Results Data showed a positive bias of the MINI VIDAS compared to the KRYPTOR (slope=1.188, R=0.9873) and negative biases of both the ARCHITECT i2000 and cobas e 411 compared to the KRYPTOR (slope=0.806, R=0.8864, and slope=0.795, R=0.8974, respectively). A comparison of results at commonly used clinical decision points for antimicrobial stewardship showed that, relative to the KRYPTOR, 21% of samples would be classified into different interpretive categories by the ARCHITECT i2000 method, 31% of samples would be classified differently by the MINI VIDAS method, and 16% of samples would be classified differently by the cobas e 411 method. Conclusions All methods showed reasonable analytical agreement; however, an analysis of result interpretation at clinical decision points showed that many samples were differentially categorized (e.g. shifted by one interpretive category) by the methods. Overall, our findings support a need for harmonization of PCT methods. Until then, institutions should independently evaluate their PCT assays against predicate methods and consider the impact on result interpretation prior to incorporating PCT into clinical practice.
降钙素原 (PCT) 是全身性细菌感染的生物标志物，可辅助抗菌药物管理决策。目前有许多 PCT 检测方法可在常用的临床免疫分析平台上使用。然而，这些检测方法的一致性以及是否可以使用相同的临床决策点来判断所有方法仍然存在问题。
对四个不同的 PCT 检测方法（雅培 ARCHITECT i2000、生物梅里埃 MINI VIDAS、罗氏 Elecsys cobas e 411 和 BRAHMS KRYPTOR）检测的 37 份剩余患者血清样本进行分析。对常见的抗菌药物治疗临床决策点（0.10、0.25 和 0.50μg/L）进行回归分析并评估相关性。
数据显示，MINI VIDAS 检测方法与 KRYPTOR 检测方法相比具有正偏倚（斜率=1.188，R=0.9873），ARCHITECT i2000 和 cobas e 411 检测方法与 KRYPTOR 检测方法相比均具有负偏倚（斜率=0.806，R=0.8864 和斜率=0.795，R=0.8974）。在抗菌药物管理中常用的临床决策点比较结果显示，与 KRYPTOR 检测方法相比，21%的样本会因 ARCHITECT i2000 检测方法的不同而被归类为不同的解释类别，31%的样本会因 MINI VIDAS 检测方法的不同而被归类为不同的解释类别，16%的样本会因 cobas e 411 检测方法的不同而被归类为不同的解释类别。
所有方法均显示出合理的分析一致性；然而，对临床决策点的结果解释分析显示，许多样本的分类方式存在差异（例如，被归类为一个不同的解释类别）。总体而言，我们的研究结果支持需要对 PCT 方法进行一致性协调。在这之前，各个机构应针对自身的 PCT 检测方法与预测方法进行独立评估，并在将 PCT 纳入临床实践之前，考虑对结果解释的影响。
