两种灰区标本处理方法对丙肝抗体检测干扰的消除效果评价

Effects of two methods of gray area sample processing in elimination of interference ofhepatitis C antibody detection

目的观察和比较两种灰区标本处理方法对丙肝抗体化学发光法检测干扰的消除效果。方法在2020年3月至2021年6月期间,研究病例是连云港市中医院检验科2017年2月至2019年11月间-20℃保存的雅培i2000SR化学发光仪检测的丙肝抗体结果即标本的吸光度和临界值比值(S/CO)>1的血清样本151例、S/CO<1的血清样本40例,以重组免疫印迹分析(RIBA)法和核酸检测(NAT)进行确认检验。以确证试验结果为标准,采用Kappa检验方法比较以小鼠血清和磷酸盐吐温缓冲液(PBST)处理标本前后的一致性,并绘制丙肝抗体受试者工作特征曲线,从而明确丙肝抗体的最佳诊断界值和灰区范围。结果雅培i2000SR化学发光仪检测丙肝抗体最佳诊断界值为5.02,其灵敏度为97.4%(186/191),特异度为94.5%(180/191)。丙肝抗体灰区范围为0.89~5.97。灰区标本处理前、小鼠血清和PBST处理后,丙肝抗体与确证试验结果的一致性Kappa值分别为0.551、0.900和0.854(χ^(2)=69.09、156.16、141.57);以雅培i2000SR检测丙肝抗体的灵敏度分别为98.3%(148/151)、100.0%(151/151)和99.1%(150/151),特异度分别为52.6%(79/151)、88.1%(133/151)和84.2%(127/151),阳性预测值分别为75.8%(151/151)、92.7%(151/151)和90.5%(151/151),阴性预测值分别为95.2%(114/151)、100.0%(151/151)和98.5%(149/151);雅培i2000SR检测丙肝抗体的曲线下面积分别为0.980、0.996和0.987。结论两种灰区标本处理方法对丙肝抗体化学发光法检测干扰的消除效果均为明显,以小鼠血清封闭处理较好。

Objective To observe the elimination effects of two methods of gray area sample processing on the interference of anti-HCV chemiluminescence detection.Methods From March 2020 to June 2021,we selected 151 serum samples with absorbance and critical value ratio(sample/cutoff,S/CO)>1 and 40 serum samples with S/CO<1 as anti-HCV results detected by the Abbott i2000sr chemiluminescence instrument frozen at-20℃in Lianyungang Traditional Chinese Medicine Hospital from February 2017 to November 2019;confirmation tests were performed by recombinant immunoblot assay(RIBA)and nucleic acid testing(NAT).Taking the confirmation test results as the standard,the Kappa test method was used to compare the consistency before and after treating the samples with mouse serum(MS)and phosphate tween buffer(PBST),and the anti-HCV receiver operating characteristic curve(ROC)was drawn to determine the best diagnostic threshold and gray area range of anti-HCV.Results The optimal diagnostic limit of the Abbott i2000sr chemiluminescence instrument for detecting anti-HCV was 5.02,with a sensitivity of 97.4%(186/191)and a specificity of 94.5%(180/191).The gray area of anti-HCV ranged from 0.89 to 5.97.The kappa values of the consistency between anti-HCV and the confirmatory test results were 0.551,0.900,and 0.854 respectively(χ^(2)=69.09,156.16,and 141.57)before the treatment of gray area samples,after the treatment of mouse serum,and PBST.The sensitivities of the Abbott i2000sr for detecting anti HCV were 98.3%(148/151),100.0%(151/151,)and 99.1%(150/151),the specificities were 52.6%(79/151),88.1%(133/151),and 84.2%(127/151),the positive predictive values were 75.8%(114/151),92.7%(140/151),and 90.5%(137/151),and the negative predictive values were 95.2%(144/151),100.0%(151/151),and 98.5%(149/151),respectively.The areas under the curve(AUC)of Abbott i2000sr for detecting anti-HCV were 0.980,0.996 and 0.987,respectively.Conclusion The two methods can eliminate the interference in the detection of anti-HCV by chemiluminescence,and mouse serum blocking is better.