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增强诊断:对用于快速诊断反应的VIASURE实时PCR检测试剂盒的全面评估

Enhancing diagnosis: a comprehensive evaluation of VIASURE real-time PCR detection kit for rapid diagnostic responses.

作者信息

Dehesa-García Blanca, Alonso Henar, Peris María Paz, Fortuño Blanca, Abad Pilar, Rezusta Antonio, Milagro Ana

机构信息

Health Research Institute Aragón, Zaragoza, Spain.

Department of Microbiology, Pediatrics, Radiology, and Public Health, Faculty of Medicine, Universidad de Zaragoza, Zaragoza, Spain.

出版信息

Microbiol Spectr. 2025 Jul;13(7):e0311124. doi: 10.1128/spectrum.03111-24. Epub 2025 May 19.

DOI:10.1128/spectrum.03111-24
PMID:40387355
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12211079/
Abstract

UNLABELLED

, a yeast that is highly resistant to antifungal treatments, represents a significant healthcare concern due to its rapid spread through surface contamination and patient colonization. A recent outbreak at the Miguel Servet University Hospital in Zaragoza, Spain, highlighted the urgent need for rapid diagnostic responses. The current 4-day duration for microbiological culture results hinders timely patient isolation and transmission prevention. This study aims to evaluate the VIASURE Real-Time PCR Detection Kit (Certest Biotec) for diagnostic performance and analytical specificity compared to the standard methodology based on culture and MALDI-TOF MS characterization. From August 2023 to December 2023, the Microbiology Service of the Miguel Servet University Hospital processed 816 diagnostic samples. Accuracy testing resulted in adequate clinical validation values, as presented here: sensitivity, 0.98 (95% confidence interval [CI], 0.90 to 1); specificity, 1 (95% CI, 0.99 to 1); positive predictive value, 0.98 (95% CI, 0.90 to 1); and negative predictive value, 1 (95% CI, 0.99 to 1). The implementation of this molecular biology test in the laboratory promises to improve diagnostic efficiency by allowing rapid patient isolation, initiation of appropriate treatment, and effective isolation measures.

IMPORTANCE

, a resilient and antifungal-resistant yeast, poses a significant healthcare threat due to its rapid spread. A recent outbreak at a hospital in Zaragoza, Spain, emphasized the urgent need for faster diagnostics. The current four-day wait for culture results hampers timely patient isolation. This retrospective and comparative study demonstrates the favorable clinical parameters of a commercially available molecular diagnostic kit. The kit allows enhanced diagnostic efficiency, swifter patient isolation, and more effective control measures in the laboratory. In conclusion, the kit addresses the pressing challenges presented by in healthcare.

摘要

未标注

[某种酵母名称],一种对抗真菌治疗具有高度抗性的酵母,因其通过表面污染和患者定植迅速传播,成为一个重大的医疗保健问题。西班牙萨拉戈萨米格尔·塞尔维特大学医院最近的一次疫情凸显了对快速诊断反应的迫切需求。目前微生物培养结果需要4天时间,这阻碍了及时的患者隔离和传播预防。本研究旨在评估VIASURE实时PCR检测试剂盒(Certest Biotec)与基于培养和基质辅助激光解吸电离飞行时间质谱(MALDI-TOF MS)鉴定的标准方法相比的诊断性能和分析特异性。2023年8月至2023年12月,米格尔·塞尔维特大学医院微生物科处理了816份诊断样本。准确性测试产生了足够的临床验证值,如下所示:敏感性为0.98(95%置信区间[CI],0.90至1);特异性为1(95%CI,0.99至1);阳性预测值为0.98(95%CI,0.90至1);阴性预测值为1(95%CI,0.99至1)。在实验室中实施这种分子生物学检测有望通过实现快速患者隔离、启动适当治疗和采取有效的隔离措施来提高诊断效率。

重要性

[某种酵母名称],一种具有抗性且抗真菌的酵母,因其迅速传播对医疗保健构成重大威胁。西班牙萨拉戈萨一家医院最近的一次疫情强调了对更快诊断的迫切需求。目前等待培养结果的四天时间阻碍了及时的患者隔离。这项回顾性比较研究证明了一种商用分子诊断试剂盒良好的临床参数。该试剂盒可提高诊断效率,更快地隔离患者,并在实验室中采取更有效的控制措施。总之,该试剂盒解决了[某种酵母名称]在医疗保健中带来的紧迫挑战。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/32e6/12211079/7cbed8d05a6a/spectrum.03111-24.f002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/32e6/12211079/fd6b02564a2b/spectrum.03111-24.f001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/32e6/12211079/7cbed8d05a6a/spectrum.03111-24.f002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/32e6/12211079/fd6b02564a2b/spectrum.03111-24.f001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/32e6/12211079/7cbed8d05a6a/spectrum.03111-24.f002.jpg

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