AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.
AIDS Patient Care STDS. 2013 Jul;27(7):387-91. doi: 10.1089/apc.2013.0115. Epub 2013 Jun 25.
We conducted a single-center prospective study to evaluate the utility of cytomegalovirus (CMV) antigenemia assay for the diagnosis of CMV-gastrointestinal disease (GID). The study subjects were HIV-infected patients with CD4 count ≤200 μL/cells who had undergone endoscopy. A definite diagnosis of CMV-GID was made by histological examination of endoscopic biopsied specimen. CMV antigenemia assay (C10/C11 monoclonal antibodies), CD4 count, HIV viral load, history of HAART, and gastrointestinal symptoms as measured by 7-point Likert scale, were assessed on the same day of endoscopy. One hundred cases were selected for analysis, which were derived from 110 cases assessed as at high-risk for CMV-GID after endoscopy screening of 423 patients. Twelve patients were diagnosed with CMV-GID. Among the gastrointestinal symptoms, mean bloody stool score was significantly higher in patients with CMV-GID than in those without (2.5 vs. 1.7, p=0.02). The area under the receiver-operating characteristic curve of antigenemia was 0.80 (95%CI 0.64-0.96). The sensitivity, specificity, positive likelihood ratio (LR), and negative LR of antigenemia were 75.0%, 79.5%, 3.7, and 0.31, respectively, when the cutoff value for antigenemia was ≥1 positive cell per 300,000 granulocytes, and 50%, 92.0%, 5.5, and 0.55, respectively, for ≥5 positive cells per 300,000 granulocytes. In conclusion, CMV antigenemia seems a useful diagnostic test for CMV-GID in patients with HIV infection. The use of ≥5 positive cells per 300,000 granulocytes as a cutoff value was associated with high specificity and high positive LR. Thus, a positive antigenemia assay with positive endoscopic findings should allow the diagnosis of CMV-GID without biopsy.
我们进行了一项单中心前瞻性研究，以评估巨细胞病毒（CMV）抗原血症检测在诊断 CMV 胃肠道疾病（GID）中的作用。研究对象为接受内镜检查的 CD4 计数≤200μL/细胞的 HIV 感染患者。通过对内镜活检标本的组织学检查明确诊断 CMV-GID。CMV 抗原血症检测（C10/C11 单克隆抗体）、CD4 计数、HIV 病毒载量、HAART 史以及通过 7 分 Likert 量表评估的胃肠道症状，均在同一天进行内镜检查时评估。共分析了 100 例患者，这些患者源自 423 例患者内镜筛查后被评估为 CMV-GID 高危的 110 例患者。12 例患者被诊断为 CMV-GID。在胃肠道症状中，CMV-GID 患者的平均血便评分明显高于无 CMV-GID 患者（2.5 比 1.7，p=0.02）。抗原血症的受试者工作特征曲线下面积为 0.80（95%CI 0.64-0.96）。当抗原血症的临界值为≥1 个阳性细胞/30 万个粒细胞时，抗原血症的灵敏度、特异性、阳性似然比（LR）和阴性 LR 分别为 75.0%、79.5%、3.7 和 0.31，而当抗原血症的临界值为≥5 个阳性细胞/30 万个粒细胞时，其灵敏度、特异性、阳性似然比和阴性 LR 分别为 50.0%、92.0%、5.5 和 0.55。总之，CMV 抗原血症似乎是 HIV 感染患者 CMV-GID 的一种有用的诊断试验。使用≥5 个阳性细胞/30 万个粒细胞作为临界值与高特异性和高阳性 LR 相关。因此，阳性抗原血症检测结合阳性内镜发现可以诊断 CMV-GID，而无需进行活检。
