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症状诊断的优势:使用Vitro S.A.公司的性传播感染CNM实时PCR试剂盒检测引起尿道炎/宫颈炎的病原体

Advantages of Syndromic Diagnostics: Detection of the Pathogens Causing Urethritis/Cervicitis with the STI CNM Real-Time PCR Kit from Vitro S.A.

作者信息

López Miguel Ángel Castaño, Porteros Héctor Toledo, De La Iglesia Salgado Alberto, Medel Josefa Vazquez, Borrero Inmaculada García

机构信息

Clinical Laboratory Department, Hospital Comarcal Infanta Elena, Huelva, Spain.

Clinical Laboratory Department, La Merced University Hospital, Osuna, Spain.

出版信息

Pol J Microbiol. 2024 Dec 13;73(4):529-534. doi: 10.33073/pjm-2024-045. eCollection 2024 Dec 1.

Abstract

The STI CNM Real-Time PCR Kit from Vitro S.A. (Spain) demonstrates high sensitivity and specificity, is cost-effective, and can detect the three main etiological agents of urethritis/cervicitis in a single multiplex PCR. Sexually transmitted infections (STIs) are a significant public health problem and a significant burden of morbidity and mortality in hospitals. The World Health Organization (WHO) estimates the number of daily infections to be 1 million. Currently, the number of infections and antimicrobial-resistant strains is rising. A rapid and accurate etiologic diagnosis is critical to solving this problem. In this study, we compared the STI CNM Real-Time PCR Kit using the Xpert CT/NG technique (Cepheid, USA) as Gold Standard for the diagnosis of and and EasyNAT MG (Ustar Biotechnologies (Hangzhou) Ltd., China) as Gold Standard for the diagnosis of infection. Regarding and , out of 200 samples, there was a match in 199 cases, with only one positive sample not being detected by the STI CNM Real-Time PCR Kit. This results in a sensitivity of 96% and a specificity of 100% for this kit. Diagnosing infection, out of 200 samples, the STI CNM Real-Time PCR Kit correctly detected all negative and positive samples, with 100% agreement compared to the reference technique. In summary, the STI assay has a very high sensitivity and specificity, comparable to other commercial diagnostic kits. Furthermore, it has the advantage of bundling the detection of the three main bacterial agents of urethritis/cervicitis, resulting in better cost efficiency.

摘要

西班牙Vitro S.A.公司生产的性传播感染(STI)CNM实时荧光定量PCR检测试剂盒具有高灵敏度和高特异性,性价比高,且能在一次多重PCR中检测出尿道炎/宫颈炎的三种主要病原体。性传播感染是一个重大的公共卫生问题,也是医院发病率和死亡率的重大负担。世界卫生组织(WHO)估计,每天的感染病例数达100万。目前,感染病例数和耐药菌株数量正在上升。快速准确的病因诊断对于解决这一问题至关重要。在本研究中,我们将STI CNM实时荧光定量PCR检测试剂盒与采用Xpert CT/NG技术(美国赛沛公司)作为淋病和沙眼衣原体诊断的金标准,以及将易安(EasyNAT)支原体检测试剂盒(中国杭州优思达生物技术有限公司)作为支原体感染诊断的金标准进行了比较。对于淋病和沙眼衣原体,在200份样本中,有199例结果相符,只有1份阳性样本未被STI CNM实时荧光定量PCR检测试剂盒检测到。该试剂盒对此的灵敏度为96%,特异性为100%。对于支原体感染的诊断,在200份样本中,STI CNM实时荧光定量PCR检测试剂盒正确检测出了所有阴性和阳性样本,与参考技术的一致性为100%。总之,STI检测方法具有非常高的灵敏度和特异性,与其他商业诊断试剂盒相当。此外,它具有同时检测尿道炎/宫颈炎三种主要细菌病原体的优势,从而具有更好的成本效益。

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