评估用于诊断和监测人类免疫缺陷病毒阳性患者巨细胞病毒病的新型定量检测方法。
Evaluation of new quantitative assays for diagnosis and monitoring of cytomegalovirus disease in human immunodeficiency virus-positive patients.
作者信息
Pellegrin I, Garrigue I, Binquet C, Chene G, Neau D, Bonot P, Bonnet F, Fleury H, Pellegrin J L
机构信息
Laboratoire de Virologie, Centre Hospitalier Regional et Université Victor Segalen, Bordeaux, France.
出版信息
J Clin Microbiol. 1999 Oct;37(10):3124-32. doi: 10.1128/JCM.37.10.3124-3132.1999.
Cobas Amplicor CMV Monitor (CMM) and Quantiplex CMV bDNA 2.0 (CMV bDNA 2.0), two new standardized and quantitative assays for the detection of cytomegalovirus (CMV) DNA in plasma and peripheral blood leukocytes (PBLs), respectively, were compared to the CMV viremia assay, pp65 antigenemia assay, and the Amplicor CMV test (P-AMP). The CMV loads were measured in 384 samples from 58 human immunodeficiency virus (HIV) type 1-infected, CMV-seropositive subjects, including 13 with symptomatic CMV disease. The assays were highly concordant (agreement, 0.88 to 0.97) except when the CMV load was low. Quantitative results for plasma and PBLs were significantly correlated (Spearman rho = 0.92). For PBLs, positive results were obtained 125 days before symptomatic CMV disease by CMV bDNA 2.0 and 124 days by pp65 antigenemia assay, whereas they were obtained 46 days before symptomatic CMV disease by CMM and P-AMP. At the time of CMV disease diagnosis, the sensitivity, specificity, and positive and negative predictive values of CMV bDNA 2.0 were 92.3, 97.8, 92.3, and 97.8%, respectively, whereas they were 92.3, 93.3, 80, and 97. 8%, respectively, for the pp65 antigenemia assay; 84.6, 100, 100, and 95.7%, respectively, for CMM; and 76.9, 100, 100, and 93.8%, respectively, for P-AMP. Considering the entire follow-up, the sensitivity, specificity, and positive and negative predictive values of CMV bDNA 2.0 were 92.3, 73.3, 52.1, and 97.1%, respectively, whereas they were 100, 55.5, 39.4, and 100%, respectively, for the pp65 antigenemia assay; 92.3, 86.7, 66.7, and 97.5%, respectively, for CMM; and 84.6, 91.1, 73.3, and 95.3%, respectively, for P-AMP. Detection of CMV in plasma is technically easy and, despite its later positivity (i.e., later than in PBLs), can provide enough information sufficiently early so that HIV-infected patients can be effectively treated. In addition, these standardized quantitative assays accurately monitor the efficacy of anti-CMV treatment.
将两种分别用于检测血浆和外周血白细胞（PBL）中巨细胞病毒（CMV）DNA的新型标准化定量检测方法——Cobas Amplicor CMV监测仪（CMM）和Quantiplex CMV分支DNA 2.0（CMV bDNA 2.0），与CMV病毒血症检测、pp65抗原血症检测以及Amplicor CMV检测（P-AMP）进行了比较。对58例1型人类免疫缺陷病毒（HIV）感染且CMV血清学阳性的受试者的384份样本进行了CMV载量检测，其中13例患有症状性CMV疾病。除CMV载量较低时外，这些检测方法具有高度一致性（一致性为0.88至0.97）。血浆和PBL的定量结果显著相关（Spearman等级相关系数=0.92）。对于PBL，CMV bDNA 2.0在症状性CMV疾病出现前125天获得阳性结果，pp65抗原血症检测在症状性CMV疾病出现前124天获得阳性结果，而CMM和P-AMP在症状性CMV疾病出现前46天获得阳性结果。在CMV疾病诊断时，CMV bDNA 2.0的敏感性、特异性、阳性预测值和阴性预测值分别为92.3%、97.8%、92.3%和97.8%，而pp65抗原血症检测分别为92.3%、93.3%、80%和97.8%；CMM分别为84.6%、100%、100%和95.7%；P-AMP分别为76.9%、100%、100%和93.8%。考虑整个随访过程，CMV bDNA 2.0的敏感性、特异性、阳性预测值和阴性预测值分别为92.3%、73.3%、52.1%和97.1%，而pp65抗原血症检测分别为100%、55.5%、39.4%和100%；CMM分别为92.3%、86.7%、66.7%和97.5%；P-AMP分别为84.6%、91.1%、73.3%和95.3%。在血浆中检测CMV在技术上较为容易，尽管其阳性出现时间较晚（即晚于PBL），但仍可在足够早的时间提供足够信息，以便对HIV感染患者进行有效治疗。此外，这些标准化定量检测方法能够准确监测抗CMV治疗的疗效。
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