Aydemir Özlem, Karakeçe Engin, Köroğlu Mehmet, Aydemir Yusuf, Terzi Hüseyin Agah, Erkorkmaz Ünal, Altindiş Mustafa
Clin Lab. 2019 Apr 1;65(4). doi: 10.7754/Clin.Lab.2018.180727.
Procalcitonin (PCT) is the precursor structure of the calcitonin hormone with 116 amino acids. The measurement of serum procalcitonin is currently being safely used in community-acquired pneumonia, bacterial peritonitis and sepsis in the diagnosis, decision on the initiation of treatment, and follow-up of the response to treatment. In this study, it is aimed to compare PCT results obtained by the VIDAS PCT that makes measurements by the enzyme-dependent fluorescence (ELFA) method and Architect PCT method, a chemiluminescent microparticle immunoassay (CMIA) that has just been put into use, both of which are B∙R∙A∙H∙M∙S licensed and have method differences.
Serum samples of 109 patients from different clinics with a PCT request were included in the study. The sera were divided into two groups and the samples were immediately studied with two methods. Cohen's Kappa (κ) coefficient was used to determine concordance between the two methods. Other parameters were analyzed by the paired t-test, and their concordance was evaluated.
In the concordance analysis study carried out by considering the significant cutoff value of 0.5 ng/mL in the clinical diagnosis of bacterial infections, the κ value was found to be 0.930, p < 0.001. Concordance was at an excellent level. Upon pairing and analyzing all the results regardless of the cutoff value, the Concordance Coefficient was found to be 0.958 (p < 0.001). It was observed that concordance was at an excellent level.
Upon comparing the patient results obtained as a result of the study, it was observed that the concordance of the methods with each other was excellent. Larger and more comprehensive studies on this issue will be helpful.
降钙素原（PCT）是一种由116个氨基酸组成的降钙素激素的前体结构。目前，血清降钙素原检测已安全应用于社区获得性肺炎、细菌性腹膜炎和脓毒症的诊断、治疗起始决策及治疗反应的随访。在本研究中，旨在比较通过酶依赖性荧光（ELFA）法进行检测的VIDAS PCT和刚投入使用的化学发光微粒子免疫分析（CMIA）——Architect PCT法所获得的PCT结果，这两种方法均获B∙R∙A∙H∙M∙S许可且存在方法差异。
本研究纳入了109例来自不同科室且有PCT检测需求患者的血清样本。血清样本被分为两组，并立即用两种方法进行检测。采用Cohen's Kappa（κ）系数来确定两种方法之间的一致性。其他参数通过配对t检验进行分析，并评估其一致性。
在针对细菌感染临床诊断中0.5 ng/mL这一显著临界值进行的一致性分析研究中，κ值为0.930，p < 0.001。一致性处于优秀水平。在不考虑临界值的情况下对所有结果进行配对和分析时，一致性系数为0.958（p < 0.001）。观察到一致性处于优秀水平。
通过比较研究获得的患者结果，观察到各方法之间的一致性非常好。对此问题进行更大规模、更全面的研究将有所助益。
