评价一种用于人血清中同时检测和区分曼氏血吸虫和埃及血吸虫感染的双重实时 PCR - 横断面研究。

Evaluation of a duplex real-time PCR in human serum for simultaneous detection and differentiation of Schistosoma mansoni and Schistosoma haematobium infections - cross-sectional study.

机构信息

Department of Microbiology and Hospital Hygiene, Bundeswehr Hospital Hamburg, Hamburg, Germany; Institute for Medical Microbiology, Virology and Hygiene, University Medicine Rostock, Rostock, Germany.

Institute of Medical Microbiology and Hygiene, Saarland University, Homburg/Saar, Germany.

出版信息

Travel Med Infect Dis. 2021 May-Jun;41:102035. doi: 10.1016/j.tmaid.2021.102035. Epub 2021 Mar 26.

DOI:10.1016/j.tmaid.2021.102035

PMID:33775915

Abstract

BACKGROUND

We evaluated a one-tube multiplex real-time PCR targeting DNA of Schistosoma haematobium complex and S. mansoni complex in serum samples obtained at different German diagnostic centers.

METHODS

Simplex real-time PCR protocols for the detection of the multi-copy DNA-repeats Dra1 of S. haematobium complex and Sm1-7 of S. mansoni complex in serum were combined to a new one-tube multiplex format. The new PCR was subjected to full validation including evaluation in a diagnostic real-life setting with travelers and migrants. PCR results were compared with those of stool and urine microscopy, serology, and circulating cathodic antigen (CCA) rapid diagnostic tests in urine. Sensitivity and specificity of the diagnostic approaches were analyzed using latent class analysis (LCA).

RESULTS

LCA assessment indicated sensitivity and specificity of 94.9% and 98.4%, respectively, for serum PCR if serology was included in the calculation, and 100% and 95.6%, respectively, if serology was not included as a parameter not necessarily associated with active infection. Agreement between the compared diagnostic procedures at genus level was fair (kappa 0.273) if serology was included and moderate (kappa 0.420) if serology was not included.

DISCUSSION

The PCR assay proved to be highly reliable for the diagnosis of schistosomiasis in travelers and migrants.

摘要

背景

我们评估了一种针对德国不同诊断中心采集的血清样本中曼氏血吸虫复合种和埃及血吸虫复合种 DNA 的单管多重实时 PCR 方法。

方法

将用于检测血清中埃及血吸虫复合种 Dra1 多拷贝 DNA 重复序列和曼氏血吸虫复合种 Sm1-7 的 simplex 实时 PCR 方案组合到一种新的单管多重格式中。对新的 PCR 进行了全面验证，包括对旅行者和移民进行诊断性实际环境中的评估。将 PCR 结果与粪便和尿液显微镜检查、血清学和尿液中循环阴离抗原（CCA）快速诊断检测进行比较。使用潜在类别分析（LCA）分析诊断方法的敏感性和特异性。

结果

LCA 评估表明，如果将血清学纳入计算，血清 PCR 的敏感性和特异性分别为 94.9%和 98.4%，如果不将血清学作为不一定与活动性感染相关的参数纳入，则分别为 100%和 95.6%。如果将血清学纳入，则在属水平上比较诊断方法的一致性为中等（kappa 0.420），如果不将血清学纳入，则一致性为适度（kappa 0.273）。