Hematopoietic Stem Cell Transplantation Unit, Hematology Department, Hospital Clínic Barcelona, Barcelona, Spain.
Clinical Microbiology Department, Hospital Clínic Barcelona, Barcelona, Spain; Institut d'Investigació Biomèdica August Pi I Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain; University of Barcelona, Institute for Global Health (ISGlobal), Barcelona, Spain.
Biol Blood Marrow Transplant. 2019 Nov;25(11):2281-2286. doi: 10.1016/j.bbmt.2019.07.016. Epub 2019 Jul 17.
Diagnosis of gastrointestinal (GI) cytomegalovirus (CMV) disease relies on the presence of GI symptoms and detection of CMV, mainly by immunohistochemistry (IHC), in GI biopsy specimens. Thus, in a symptomatic patient, a positive CMV-IHC result is accepted as a diagnosis of CMV disease. However, a positive CMV-PCR in GI tissue is considered "possible" CMV disease. Therefore, it would be very useful if, in practice, both techniques showed equal sensitivity and reliability. This is because PCR has many practical advantages over IHC for detecting CMV. The aim of this study was to compare quantitative PCR with IHC for the diagnosis of GI CMV disease. A total of 186 endoscopic GI biopsy specimens from 123 patients with GI symptoms after an allogeneic stem cell transplantation (allo-SCT; 2004-2017) were analyzed by IHC and PCR on 113 paraffin-embedded and 73 fresh samples. The results were then compared. Of the patients with macroscopic lesions in the mucosa and CMV-IHC-positive biopsy specimens (eg, "proven" CMV disease, n = 28), all but 1 were CMV-PCR positive. Of the patients without macroscopic lesions in the mucosa and CMV-IHC-positive biopsy specimens (eg, probable CMV disease, n = 4), only 1 was CMV-PCR positive. Eight patients had CMV-IHC-negative/CMV-PCR-positive gut biopsy specimens. These cases fall within the current definition of possible CMV disease. In 6 of these 8 cases (75%), the viral load in GI tissue was very high (>10,000 copies/µg). Taken together, the results from the proven and probable cases revealed that CMV-PCR shows the same sensitivity (100%), specificity (98%), and positive (93%) and negative predictive value (100%) as CMV-IHC. Detection of CMV in fresh GI mucosa by quantitative PCR is as useful as IHC for the diagnosis of GI CMV disease. The results show that quantitative PCR has the same sensitivity, specificity, and positive/negative predictive value as IHC.
胃肠道（GI）巨细胞病毒（CMV）疾病的诊断依赖于胃肠道症状的存在和 GI 活检标本中 CMV 的检测，主要通过免疫组织化学（IHC）进行。因此，在有症状的患者中，CMV-IHC 阳性结果被认为是 CMV 疾病的诊断。然而，GI 组织中的 CMV-PCR 阳性结果被认为是“可能”的 CMV 疾病。因此，如果这两种技术在实践中都具有相同的敏感性和可靠性，将会非常有用。这是因为 PCR 在检测 CMV 方面比 IHC 具有许多实际优势。本研究旨在比较定量 PCR 与 IHC 用于诊断 GI CMV 疾病。对 123 例异基因干细胞移植（allo-SCT；2004-2017 年）后出现胃肠道症状的患者的 186 份内镜 GI 活检标本进行了分析，使用 IHC 和 PCR 对 113 份石蜡包埋和 73 份新鲜样本进行了分析。然后比较了结果。在有宏观黏膜病变和 CMV-IHC 阳性活检标本的患者（例如，“明确”CMV 疾病，n=28）中，除 1 例外，所有患者的 CMV-PCR 均为阳性。在没有宏观黏膜病变和 CMV-IHC 阳性活检标本的患者（例如，可能的 CMV 疾病，n=4）中，只有 1 例患者的 CMV-PCR 为阳性。8 例患者的 GI 活检标本 CMV-IHC 阴性/CMV-PCR 阳性。这些病例属于目前可能的 CMV 疾病的定义范围。在这 8 例中的 6 例（75%）中，GI 组织中的病毒载量非常高（>10,000 拷贝/µg）。综合明确和可能的病例结果表明，CMV-PCR 的敏感性（100%）、特异性（98%）、阳性预测值（93%）和阴性预测值（100%）与 CMV-IHC 相同。通过定量 PCR 检测新鲜 GI 黏膜中的 CMV 对诊断 GI CMV 疾病与 IHC 一样有用。结果表明，定量 PCR 与 IHC 具有相同的敏感性、特异性和阳性/阴性预测值。
