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评估 eazyplex MRSA 检测试剂盒在快速检测胸腔积液和滑液中的金黄色葡萄球菌中的应用。

Evaluation of the eazyplex MRSA assay for the rapid detection of Staphylococcus aureus in pleural and synovial fluid.

机构信息

Institut de Recerca Pediàtrica, Departament de Microbiologia Molecular, Hospital Sant Joan de Déu, Barcelona, Spain.

Institut de Recerca Pediàtrica, Departament de Microbiologia Molecular, Hospital Sant Joan de Déu, Barcelona, Spain; CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.

出版信息

Int J Infect Dis. 2017 Jun;59:65-68. doi: 10.1016/j.ijid.2017.04.013. Epub 2017 Apr 24.

DOI:10.1016/j.ijid.2017.04.013
PMID:28450195
Abstract

OBJECTIVE

Loop-mediated isothermal amplification (LAMP) is a simple and sensitive technique for rapid microbiological diagnosis. The aim of this study was to evaluate the analytical and diagnostic performance of the LAMP eazyplex MRSA test for the direct detection and differentiation of methicillin-susceptible (MSSA) and methicillin-resistant Staphylococcus aureus (MRSA) in synovial/pleural fluid.

METHODS

Analytical validation included the determination of the limit of detection (LoD) and analytical specificity of the eazyplex MRSA test. A diagnostic evaluation of the eazyplex test against bacterial culture was performed on routine pleural/synovial samples collected prospectively from patients aged less than 18 years with complicated pneumonia with empyema or arthritis admitted to the Children's Hospital Sant Joan de Déu in Barcelona, Spain, between April 2015 and May 2016.

RESULTS

The new system appropriately detected a quality control panel of clinical samples with DNA of MSSA, MRSA, and other pathogens. The LoD was established at 6.4×10 CFU/ml for S. aureus and 1.0×10 CFU/ml for MRSA. Diagnostic validation of the eazyplex MRSA assay was performed on 51 prospective clinical invasive samples, resulting in sensitivity and specificity values of 83.3% and 97.8%, respectively, for S. aureus detection. The mean turnaround time was 70min.

CONCLUSIONS

The eazyplex MRSA assay was found to be a useful test for the rapid detection of S. aureus in invasive samples such as pleural/synovial fluid.

摘要

目的

环介导等温扩增(LAMP)是一种用于快速微生物诊断的简单而灵敏的技术。本研究旨在评估 LAMP eazyplex MRSA 试验直接检测和区分耐甲氧西林敏感金黄色葡萄球菌(MSSA)和耐甲氧西林金黄色葡萄球菌(MRSA)的分析和诊断性能,用于检测滑液/胸腔液中的耐甲氧西林金黄色葡萄球菌。

方法

分析验证包括确定 eazyplex MRSA 试验的检测限(LoD)和分析特异性。对 2015 年 4 月至 2016 年 5 月期间在西班牙巴塞罗那圣若翰儿童医院因复杂性肺炎伴脓胸或关节炎住院的年龄小于 18 岁的患者前瞻性收集的常规胸腔液/滑液样本进行了细菌培养的 eazyplex 试验的诊断评估。

结果

新系统适当地检测了临床样本 DNA 的 MSSA、MRSA 和其他病原体的质量控制面板。S. aureus 的 LoD 确定为 6.4×10 CFU/ml,MRSA 的 LoD 确定为 1.0×10 CFU/ml。对 51 份前瞻性临床侵袭性样本进行了 eazyplex MRSA 检测的诊断验证,结果显示 S. aureus 的敏感性和特异性值分别为 83.3%和 97.8%。平均周转时间为 70 分钟。

结论

eazyplex MRSA 检测法是一种用于快速检测侵袭性样本(如胸腔液/滑液)中金黄色葡萄球菌的有用检测方法。

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