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初步临床研究使用多重实时 PCR 检测直接在血液中细菌和真菌的 DNA。

Preliminary clinical study using a multiplex real-time PCR test for the detection of bacterial and fungal DNA directly in blood.

机构信息

Pôle de Microbiologie, Centre Hospitalier Universitaire de Lille, Faculte de Medicine de Lille, France.

出版信息

Clin Microbiol Infect. 2010 Jun;16(6):774-9. doi: 10.1111/j.1469-0691.2009.02940.x. Epub 2009 Aug 18.

DOI:10.1111/j.1469-0691.2009.02940.x
PMID:19689465
Abstract

Early diagnosis of sepsis, rapid identification of the causative pathogen(s) and prompt initiation of appropriate antibiotic treatment have a combined impact on mortality due to sepsis. In this observational study, a new DNA-based system (LightCycler SeptiFast (LC-SF) test; Roche Diagnostics) allowing detection of 16 pathogens at the species level and four groups of pathogens at the genus level has been evaluated and compared with conventional blood cultures (BCs). One hundred BC and LC-SF results were obtained for 72 patients admitted to the intensive-care unit over a 6-month period for suspected sepsis. Microbiological data were compared with other biological parameters and with clinical data. The positivity rate of BCs for bacteraemia/fungaemia was 10%, whereas the LC-SF test allowed detection of DNA in 15% of cases. The LC-SF performance, based on its clinical relevance, was as follows: sensitivity, 78%; specificity, 99%; positive predictive value, 93%; and negative predictive value, 95%. Management was changed for four of eight (50%) of the patients because organisms were detected by the LC-SF test but not by BC. LC-SF results were obtained in 7-15 h, in contrast to the 24-72 h required for BC. According to the LC-SF results, initial therapy was inadequate in eight patients, and antibiotic treatment was changed. Our results suggest that the LC-SF test may be a valuable complementary tool in the management of patients with clinically suspected sepsis.

摘要

早期诊断脓毒症、快速鉴定病原体以及及时给予恰当的抗生素治疗,三者结合可降低脓毒症的死亡率。本研究旨在评价一种新的基于 DNA 的系统(罗氏诊断 LightCycler SeptiFast[LC-SF]检测),该系统可在种属水平上同时检测 16 种病原体和 4 组病原体,与传统血培养(BC)进行比较。我们对在重症监护病房接受疑似脓毒症治疗的 72 例患者的 100 份 BC 和 LC-SF 检测结果进行了为期 6 个月的前瞻性观察研究。将微生物学数据与其他生物学参数和临床数据进行了比较。BC 对菌血症/真菌血症的阳性率为 10%,而 LC-SF 检测可在 15%的病例中检测到 DNA。根据临床相关性,LC-SF 的性能如下:灵敏度为 78%,特异性为 99%,阳性预测值为 93%,阴性预测值为 95%。因为 LC-SF 检测到而 BC 未检测到病原体,所以有 4 例(50%)患者的治疗方案发生了改变。LC-SF 检测可在 7-15 小时内获得结果,而 BC 则需要 24-72 小时。根据 LC-SF 检测结果,有 8 例患者的初始治疗不充分,需要调整抗生素治疗。我们的研究结果表明,LC-SF 检测可能是临床疑似脓毒症患者管理的一种有价值的辅助工具。

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