Clinical utility of in-hospital qPCR for cytomegalovirus detection: a single-center analysis

IF 1.9 4区医学 Q3 INFECTIOUS DISEASES

Journal of Infection and Chemotherapy Pub Date : 2025-04-22 DOI:10.1016/j.jiac.2025.102715

Mai Oikawa , Shingo Tanaka , Takashi Kondo , Makito Tanaka , Ryo Kobayashi , Ryosei Murai , Satoshi Iyama , Satoshi Takahashi

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引用次数: 0

Abstract

Introduction

Cytomegalovirus (CMV) reactivation is a major concern in immunocompromised patients. This study aimed to evaluate the clinical utility of in-hospital quantitative real-time polymerase chain reaction (qPCR) testing for CMV detection compared with the conventional antigenemia (AG) assay.

Methods

We analyzed 1327 tests performed on 274 patients between January 2022 and December 2023 at a single institution. CMV DNA levels were measured using the Cobas 6800 system, and the results were compared with those of the AG assay. Concordance rates between the two methods were assessed, and the correlation between CMV DNA levels and AG-positive cell counts was analyzed. Clinical case studies were also reviewed to evaluate longitudinal performance.

Results

The number of qPCR tests increased steadily, with 71 % of the results available within one day and an average turnaround time of approximately 1.2 days. qPCR and AG concordance were evaluated in 326 tests, showing overall agreement rates of 68.7%–85.3%, depending on the positivity criteria. The positive agreement between qPCR and AG was 100 % when the detection threshold was set at a positive qPCR threshold ≥34.5 IU/mL or below the lower limit of quantification. A positive correlation was observed between the CMV DNA levels and AG-positive cell counts (Spearman r = 0.679).

Conclusion

In-hospital qPCR for CMV detection yielded rapid, reliable, and standardized results. These findings support its role as an essential diagnostic tool in hematological and transplant settings, where timely CMV monitoring is critical for patient management.

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院内qPCR检测巨细胞病毒的临床应用：单中心分析

巨细胞病毒（CMV）再激活是免疫功能低下患者关注的主要问题。本研究旨在评价院内实时定量聚合酶链反应（qPCR）检测巨细胞病毒与常规抗原血症（AG）检测的临床应用价值。方法：我们分析了2022年1月至2023年12月在同一家机构对274例患者进行的1327项检测。采用Cobas 6800系统检测CMV DNA水平，并与AG检测结果进行比较。评估两种方法的一致性，并分析巨细胞病毒DNA水平与ag阳性细胞计数之间的相关性。临床病例研究也进行了回顾，以评估纵向性能。结果qPCR检测的数量稳步增加，71%的结果在一天内可获得，平均周转时间约为1.2天。对326例试验进行qPCR和AG一致性评估，根据阳性标准，总体一致性率为68.7%-85.3%。当检测阈值为qPCR阳性阈值≥34.5 IU/mL或低于定量下限时，qPCR与AG的阳性一致性为100%。CMV DNA水平与ag阳性细胞数呈正相关（Spearman r = 0.679）。结论院内qPCR检测巨细胞病毒结果快速、可靠、标准化。这些发现支持其作为血液学和移植环境中必不可少的诊断工具的作用，在这些环境中，及时监测巨细胞病毒对患者管理至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Infection and Chemotherapy INFECTIOUS DISEASES-PHARMACOLOGY & PHARMACY

CiteScore

4.10

自引率

4.50%

发文量

303

审稿时长

47 days

期刊介绍： The Journal of Infection and Chemotherapy (JIC) — official journal of the Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases — welcomes original papers, laboratory or clinical, as well as case reports, notes, committee reports, surveillance and guidelines from all parts of the world on all aspects of chemotherapy, covering the pathogenesis, diagnosis, treatment, and control of infection, including treatment with anticancer drugs. Experimental studies on animal models and pharmacokinetics, and reports on epidemiology and clinical trials are particularly welcome.