目的：评价血清降钙素原（PCT）定量检测在全身和局部细菌感染诊断中的临床应用价值。方法采用美国临床实验室标准化协会（CLSI）颁布的EP15-A2文件验证罗氏Cobas E601电化学发光免疫检测系统（简称Cobas E601）检测PCT的精密度和准确度，保证仪器条件符合实验要求。收集全身和局部细菌感染住院患者697例，联合分析患者血培养、痰培养、中段尿培养和脑脊液培养数据及其血清PCT结果，比较全身感染和局部感染及不同部位感染患者血清PCT的变化趋势，并分析革兰阳性球菌和革兰阴性杆菌感染机体PCT的表达差异情况。结果 Cobas E601检测PCT具有良好的重复性，总变异系数（CV）＜3．59％，与定值校准品的偏差＜5．0％，符合临床检测要求。血清PCT水平在全身和局部感染患者中均升高，且全身感染患者PCT水平明显高于局部感染患者（P＜0．05）；在局部感染中，呼吸系统、泌尿系统和神经系统感染组间血清PCT水平差异无统计学意义（P＞0．05）。在全身感染中，革兰阴性杆菌感染患者血清PCT水平高于革兰阳性球菌感染患者（P＜0．05）；在局部感染中，此2类细菌感染患者血清PCT水平差异无统计学意义（P＞0．05）。结论血清PCT水平在全身感染和局部感染患者样本中均升高，在局部感染中不能通过血清PCT水平鉴别革兰阴性杆菌和革兰阳性球菌的感染。%Objective To evaluate the clinical application significance of serum procalcitonin(PCT)quantitation determination in the diagnosis of systemic and local bacterial infections.Methods The Clinical and Laboratory Standards Institute (CLSI)EP15-A2 document was employed to verify the precision and accuracy of PCT determination by Roche Cobas E601 chemiluminescence analyzer (Cobas E601)and ensure instrument conditions being complied with the requirement of experiment.A total of 697 patients with systemic and local bacterial infections were enrolled.The results of serum PCT determination,blood culture,sputum culture,middle-urine culture and cerebrospinal culture were used to compare the change trends of serum PCT for systemic and local bacterial infections and for different-part infections.The difference of PCT in Gram-positive cocci and Gram-negative bacilli infections was analyzed.Results Cobas E601 had good repeatability,and the total coefficient of variation (CV)was <3.59%.The fixed calibration bias was <5 .0% and met the clinical determination requirements.For serum PCT,there was significance for systemic and local bacterial infections with having increasing serum PCT level(P<0.05).For local bacterial infection,there was no statistical significance for respiratory system,urinary system and nervous system infections (P>0.05 ).For systemic bacterial infection,there was higher serum PCT level for patients with Gram-negative bacilli infection than with Gram-positive cocci infection (P<0.05 ).For local bacterial infection,there was no statistical significance for patients with Gram-negative bacilli infection and Gram-positive cocci infection (P>0.05 ).Conclusions In patients with systemic and local bacterial infections,serum PCT level has high expression,and serum PCT level can not identify local bacterial infection Gram-negative bacilli and Gram-positive cocci infections.
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