临床应用两种检测血清C反应蛋白方法的性能评价比较  

Comparative evaluation of the performance of two commonly used methods for serum C-reactive protein detection in clinic

作　　者：马翠珍 黄涛 Ma Cuizhen;Huang Tao(Department of Laboratory Medicine,Jiexiu People′s Hospital,Jinzhong,Shanxi 032000,China;Institute for Viral Disease Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China)

机构地区：[1]介休市人民医院检验科,山西介休032000 [2]中国疾病预防控制中心病毒病所,北京昌平102206

出　　处：《中国药物与临床》2023年第6期376-381,共6页Chinese Remedies & Clinics

摘　　要：目的评价和比较实验室常用的免疫透射比浊法和散射比浊法对血清中C反应蛋白(C-reaction protein,CRP)检测效果。方法通过免疫透射比浊法和免疫散射比浊法检测血清CRP的结果,进行精密度、线性、准确度、一致性、抗干扰性评估,并通过临床样本进行参考区间验证。结果免疫散射比浊法批内精密度(0.46%~4.80%)和批间精密度(1.02%~5.26%)结果分别优于免疫透射比浊法批内精密度(1.33%~9.37%)和批间精密度(1.66%~9.84%)。此外,通过免疫透射比浊法与免疫散射比浊法间Passing-Bablok回归分析,方程为:Y=-0.657(-1.012~0.611)+1.080(0.973~1.034)X,经Cusum线性检验验证结果显示2种CRP比浊检测方法间偏倚差异无统计学意义(P>0.05)。线性回归评估分析结果,免疫透射比浊法Y=1.083X-2.822,R2=0.990;免疫散射比浊法Y=1.027X~1.202,R2=0.996。2种免疫比浊法检测50 mg/L CRP检测临界浓度结果的一致率为97.5%。结合胆红素(conjugated bilirubin,CBil)、游离胆红素(free bilirubin,FBil)、血红蛋白(hemoglobin,Hb)和乳糜干扰物质对检测CRP的2种方法进行干扰评估结果显示2种CRP检测的免疫比浊法的干扰率均<10%。2种检测方法对40名健康人血清结果均符合厂商建议(≤10 mg/L)参考区间。结论免疫散射比浊法和免疫透射比浊法2种检测方法测量CRP时的精密度、线性评估、准确率、一致性、抗干扰性、参考区间均符合临床检测和应用要求,且前者整体检测性能优于后者。Objective To evaluate and compare the efficacy of immunotransmission turbidimetry and immunoscattering turbidimetry in the detection of CRP in serum.Methods The precision,linearity,accuracy,consistency and anti-interference of serum CRP were evaluated by immunotransmission turbidimetry and im-munoscattering turbidimetry,and reference interval was verified by clinical samples.Results The intra-batch precision(0.46%~4.80%)and inter-batch precision(1.02%~5.26%)of immunoscattering turbidimetric method were better than that of immunotransmission turbidimetric method(1.33%~9.37%)and inter-batch precision(1.66%~9.84%),respectively.In addition,the Passing-Bablok regression analysis equation between immune transmission turbidimetry and immune scattering turbidimetry is as follows:Y=-0.657(-1.012~0.611)+1.080(0.973~1.034)X,Cusum test for linearity showed that there was no significant difference in bias between the two CRP turbidity detection methods(P>0.05).In the linear regression analysis,Y=1.083X-2.822,R2=0.990 immuno-transmission turbidimetry and Y=1.027X-1.202,R2=0.996 for the immunoscattering turbidimetry.The agreement rate of the critical concentration of 50 mg/L CRP detected by the two immunoturbidimetric methods was 97.5%.Interference assessment of the two methods for conjugated bilirubin,free bilirubin,hemoglobin and chylous inter-fering substances showed that the interference rates were less than 10%for both CRP assays.The results of the two detection methods for 40 healthy subjects were in line with the reference interval suggested by manufacturers(≤10 mg/L).Conclusion The precision,linear evaluation,accuracy,consistency,anti-interference and reference interval of immunoturbidimetry and immunotransmission turbidimetry meet the requirements of clinical detection and application, and the overall detection performance of the former is better than that of the latter.

关 键 词：透射比浊法 散射比浊法 免疫比浊法 C反应蛋白质 

分 类 号：R446.6[医药卫生—诊断学]