Eidizadeh Abass, Wiederhold Mechthild, Schnelle Moritz, Binder Lutz
Institute for Clinical Chemistry/Interdisciplinary UMG Laboratory, University Medical Center Goettingen, Robert-Koch-Str. 40, 37075, Goettingen, Germany.
Pract Lab Med. 2022 Apr 12;30:e00274. doi: 10.1016/j.plabm.2022.e00274. eCollection 2022 May.
Procalcitonin (PCT) is an important biomarker of sepsis and respiratory infections. Various automated immunoassays for measuring PCT in patient plasma are available in medical laboratories. However, due to a lack of international reference material for PCT, the assays are not always comparable.
In this study, we compared a new turbidimetric immunoassay from DiaSys, measured on the Abbott Architect c16000 and Alinity c, with four BRAHMS-associated chemiluminescence immunoassays (Abbott Architect i2000SR, Alinity i, Roche Cobas e411 and DiaSorin Liaison XL) using 120 random patient plasma samples from the clinical laboratory routine at the University Medical Center Goettingen.
The DiaSys assay showed clear differences as compared to the BRAHMS-associated assays when measured on Architect c: i.e. 58% positive mean bias vs. Architect i, 67% vs. Cobas and 23% vs. Liaison. As a result, additional 19% our patients would have a suspected bacterial infection, when using PCT values from the DiaSys assay and commonly accepted decision limits. A crosscheck of the DiaSys calibrator on the BRAHMS-associated systems showed a low recovery of the calibrator material (approx. 50%).
Overall, this study shows significant differences between the DiaSys and BRAHMS-associated assays. This could be attributed to a potential DiaSys calibrator problem. This highlights the need for an international reference material for harmonization of the PCT assays.
降钙素原（PCT）是脓毒症和呼吸道感染的重要生物标志物。医学实验室有多种用于检测患者血浆中PCT的自动化免疫测定法。然而，由于缺乏PCT的国际参考物质，这些测定法并不总是具有可比性。
在本研究中，我们使用来自哥廷根大学医学中心临床实验室常规检测的120份随机患者血浆样本，将DiaSys公司的一种新的比浊免疫测定法（在雅培Architect c16000和Alinity c上进行检测）与四种BRAHMS相关的化学发光免疫测定法（雅培Architect i2000SR、Alinity i、罗氏Cobas e411和DiaSorin Liaison XL）进行了比较。
当在Architect c上进行检测时，DiaSys测定法与BRAHMS相关测定法相比显示出明显差异：即与Architect i相比平均正偏差为58%，与Cobas相比为67%，与Liaison相比为23%。因此，当使用DiaSys测定法的PCT值和普遍接受的判定界限时，另外19%的患者会被怀疑有细菌感染。在BRAHMS相关系统上对DiaSys校准品进行交叉检查显示校准品材料的回收率较低（约50%）。
总体而言，本研究表明DiaSys测定法与BRAHMS相关测定法之间存在显著差异。这可能归因于DiaSys校准品存在潜在问题。这突出了需要一种国际参考物质来统一PCT测定法的必要性。
