SAT法检测人巨细胞病毒pp67 mRNA在人类免疫缺陷病毒合并人巨细胞病毒感染患者临床诊疗中的价值探讨  

The value of SAT detection of human cytomegalovirus pp67 mRNA in the clinical diagnosis and treatment of human immunodeficiency virus patients with human cytomegalovirus infection

作　　者：孟欢 王爽 何超男 韩莹 潘美晨 殷商启 郑梅 金方方 王雅杰 Meng Huan;Wang Shuang;He Chaonan;Han Ying;Pan Meichen;Yin Shangqi;Zheng Mei;Jin Fangfang;Wang Yajie(Department of Clinical Laboratory,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China)

机构地区：[1]首都医科大学附属北京地坛医院检验科,北京100015

出　　处：《首都医科大学学报》2021年第5期739-746,共8页Journal of Capital Medical University

基　　金：吴阶平医学基金会临床科研专项资助基金(320.6750.2020-08-35)。

摘　　要：目的探讨实时荧光核酸恒温扩增检测技术(simultaneous amplification and testing,SAT)检测人巨细胞病毒(human cytomegalovirus,HCMV)基质表层蛋白pp67(phosphoprotein67,pp67)mRNA在人类免疫缺陷病毒(human immunodeficiency virus,HIV)合并HCMV感染患者临床诊疗中的价值。方法利用SAT技术构建检测HCMV pp67 mRNA的方法,评估SAT法检测HCMV pp67 mRNA重复性、特异性以及检测下限;收集HIV阳性HCMV活动性感染患者69例、HIV阳性HCMV非活动性/潜伏感染154例、HIV阴性HCMV非活动性/潜伏感染79例患者的血清、肺泡灌洗液、脑脊液等样本进行HCMV pp67 mRNA检测,评估特异度、灵敏度、正确率、阴性预测值、阳性预测值以及约登指数,评估HCMV pp67 mRNA在辨别HCMV活动性感染中的临床价值。结果SAT法检测HCMV pp67 mRNA的精密度(变异系数<10%)可满足临床检测要求,与其他病原体无交叉反应,特异性良好,试剂检测下限为400 copies/mL;特异度87.55%,灵敏度60.87%,正确率81.46%,阴性预测值0.88,阳性预测值0.59以及约登指数0.48;SAT法检测HCMV pp67 mRNA结果阳性率与临床诊断结果差异无统计学意义(P=0.894)。结论SAT法检测HCMV pp67 mRNA可用于HCMV活动性感染的辅助诊断。Objective To investigate the clinical value of simultaneous amplification and testing(SAT)method in detecting human cytomegalovirus(HCMV)phosphoprotein67(pp67)mRNA in HIV patients with HCMV infection.Methods The SAT technique was used to construct a method for HCMV pp67 mRNA detection,and the repeatability,specificity and detection limit of HCMV pp67 mRNA were evaluated.HCMV pp67 mRNA was detected in serum,alveolar lavage fluid and cerebrospinal fluid samples from 69 HIV-positive patients with active HCMV infection,154 HIV-positive patients with inactive/latent HCMV infection and 79 HIV-negative patients with inactive/latent HCMV infection.Specificity,sensitivity,accuracy,negative predictive value,positive predictive value,and Youden index were evaluated to evaluate the clinical value of HCMV pp67 mRNA in the identification of HCMV active infection.Results The precision(coefficient of variance<10%)of HCMV pp67 mRNA detected by SAT could meet the clinical requirements.There was no cross-reaction with other pathogens,and the specificity was good.The specificity was 87.55%,the sensitivity was 60.87%,the accuracy was 81.46%,the negative predictive value was 0.88,the positive predictive value was 0.59,and the Youden index was 0.48.There was no significant difference between the positive rate of pp67 mRNA detected by SAT and the clinical diagnosis(P=0.894).Conclusion The SAT method used in the detection of the HCMV pp67 mRNA can be used for auxiliary diagnosis of HCMV active infection.

关 键 词：人免疫缺陷病毒 巨细胞病毒活动性感染 实时荧光核酸恒温扩增检测技术 人巨细胞病毒pp67 mRNA 

分 类 号：R446[医药卫生—诊断学]