全血C反应蛋白检测系统性能评价的多中心研究

Evaluation of the performance of systems for whole blood C-reactive protein detection:a multi-center study

目的研究目前常用的全血C反应蛋白(CRP)检测系统的性能,并给出建议的全血CRP检测系统性能要求。方法收集2019年3—4月26家妇幼及儿童医院7540份静脉血样本,研究5种常用全血CRP检测系统分析性能。5种全血CRP检测系统包括迈瑞BC-5390CRP全自动血液细胞分析仪、国赛Astep PLUS特定蛋白分析仪、奥普OTTOMAN-1000全自动特定蛋白即时检测分析仪、韩国i-CHROMA Reader免疫分析仪和芬兰Orion QuikRead go定量分析仪,均使用原装配套试剂,并分别以a、b、c、d、e随机顺序代表检测系统。5种全血CRP检测系统与采用血清模式的西门子特定蛋白分析仪的CRP检测结果进行比对,对检测系统的性能,包括空白测定、携带污染、重复性、中间精密度、线性范围、干扰实验、结果相关性、正确度和样本稳定性进行评价。结果5种常用的全血CRP检测系统空白测定值均<1.00 mg/L,携带污染<1.00%。重复性结果显示,CRP浓度在3.00~10.00 mg/L范围时,>97%的样本变异系数(CV)<10.00%;CRP浓度在10.00~30.00 mg/L范围时,>98%的样本CV<6.00%;CRP浓度>30.00 mg/L时,>98%的样本CV<5.00%;中间精密度均<10.00%;参与评估的检测系统线性理论值及实测值的相关系数(r)均>0.975,斜率在0.950~1.050。样本稳定性实验结果显示,样本在室温(18~25℃)或冷藏(2~8℃)保存72 h内,全血CRP检测结果相对偏差均在10.00%以内;干扰试验表明,除采用干化学免疫速率法的检测系统外,加入甘油三酯(TG)浓度<15.46 mmol/L时,加入TG与未加入TG样本CRP偏差均<10.00%;加入胆红素浓度<345.47μmol/L时,加入胆红素与未加入胆红素样本CRP偏差均<10.00%;在无血细胞比容(Hct)校正功能的检测系统中,Hct不同稀释浓度点与40%稀释浓度点相比相对偏差最高可达67.48%;5种全血CRP检测系统与西门子特定蛋白分析仪的CRP检测结果进行比对,0~300.00 mg/L范围内,各检测系统r均>0.975;使用上海市临床检验中心发放的指定值分别为12.89和30.60 mg/L的正确度能力验证样品,参与正确度验证的全血CRP检测系统均通过正确度验证。结论5种全血CRP检测系统性能基本满足临床需求,但建议无自动Hct修正的全血CRP检测系统进行手动修正。

Objective To explore the performance of the commonly used whole blood C-reactive protein(CRP)detection systems and give related recommendation on the performance requirements of detection systems.Methods A total of 7540 venous blood samples from 26 maternal,child and children′s hospitals were collected to conduct this multi-center study on the analytical performance of 5 commonly used whole blood CRP detection systems from March to April in 2019.The blank check,carryover,repeatability,intermediate precision,linearity,sample stability,influence of hematocrit/triglyceride/bilirubin,comparison with SIEMENS specific protein analyzer and trueness were evaluated.The 5 systems included BC-5390CRP autohematology analyzer,AstepPLUS specific protein analyzer,Ottoman-1000 Automated Specific Protein POCT Workstation,i-CHROMA Immunofluorometer equipment Reader and Orion QuikRead go detecting instrument.The 5 systems were labeled as a,b,c,d and e randomly.Results Within the 5 systems,all values of blank check were less than 1.00 mg/L,the carryovers were lower than 1.00%.The repeatability of different ranges of CRP concentrations including 3.00-10.00,10.00-30.00 and>30.00 mg/L were less than 10.00%,6.00%and 5.00%,respectively,and the intermediate precision was less than 10.00%.The linearity correlation coefficients of the 5 systems were all above 0.975,while the slope was within 0.950-1.050.Whole blood samples were stable within 72 hours both at room temperature(18-25℃)and refrigerated temperature(2-8℃).The CRP results were rarely influenced by high triglyceride or bilirubin,except for the immmunoturbidimetric test based on microparticles coated with anti-human CRP F(ab)2 fragments.When triglyceride was less than 15.46 mmol/L,the deviation of CRP was less than 10.00%.When bilirubin was less than 345.47μmol/L,the deviation of CRP was less than 10.00%.CRP was more susceptible to Hct on the systems without Hct correction.The deviation of CRP between different Hct dilution concentration and 40%dilution concentration can reach as high as 67.48%.The correlation coefficients(r)of 5 systems were all more than 0.975 in the range of 0-300.00 mg/L compared with Siemens specific protein analyzer.All systems passed the trueness verification using the samples with specified values of 12.89 and 30.60 mg/L.Conclusion The performance of 5 systems can basically meet the clinical needs,but it is suggested that the whole blood CRP detection system without automatic Hct correction should be modified manually.