Unit of Microbiology, The Great Romagna Area Hub Laboratory, Pievesestina, Italy.
Morgagni-Pierantoni Hospital, Forlì, Italy.
PLoS One. 2018 May 15;13(5):e0197436. doi: 10.1371/journal.pone.0197436. eCollection 2018.
Bloodstream infection (BSI) and associated sepsis represent a major source of mortality in industrialized countries. Prompt treatment with targeted antibiotics affects both the financial impact and the clinical outcome of BSI: every hour gained in initiating the correct antimicrobial therapy significantly increases the probability of patient survival. However, the current standard-of-care, which depends on blood culture-based diagnosis, are often unable to provide such a fast response. Fast and sensitive molecular techniques for the detection of sepsis-related pathogens from primary blood samples are strongly needed. The aim of this study was to assess the usefulness of the IRIDICA BAC BSI Assay, a PCR/ESI-MS-based technology for the early diagnosis of bloodstream infections from primary blood samples in critical patients. This evaluation has been performed by comparison with the traditional culture-based methods. The study was performed on a total of 300 prospective whole blood specimens obtained from patients suspected of sepsis, admitted to enrolling ER units from The Greater Romagna Area. The overall concordance between the two techniques was of 86%, with a calculated sensitivity of 76% and an assay specificity of 90%. The clinical significance of discrepant results was evaluated reviewing the patients' clinical records and the results of additional relevant microbiological tests. The data here obtained support the ability of the IRIDICA BAC BSI Assay to identify a broad range of bacteria directly from primary whole blood samples, within eight hours. This might allow a timely administration of a suitable treatment.
血流感染（BSI）和相关的败血症是工业化国家主要的死亡原因之一。及时使用靶向抗生素进行治疗会影响 BSI 的财务影响和临床结果：在开始正确的抗菌治疗方面每获得一个小时，都会显著增加患者存活的可能性。然而，目前依赖于血培养诊断的标准治疗方法往往无法提供如此快速的响应。迫切需要快速而敏感的分子技术，以便从原发性血液样本中检测出与败血症相关的病原体。本研究旨在评估 IRIDICA BAC BSI 检测的有效性，该检测是一种基于 PCR/ESI-MS 的技术，用于从重症患者的原发性血液样本中早期诊断血流感染。通过与传统的基于培养的方法进行比较，对该方法进行了评估。该研究共纳入了 300 份来自疑似败血症患者的前瞻性全血标本，这些患者均来自大罗马涅地区的急诊室。两种技术之间的总体一致性为 86%，计算出的灵敏度为 76%，检测特异性为 90%。通过回顾患者的临床记录和其他相关微生物学检测的结果，评估了不一致结果的临床意义。这里获得的数据支持 IRIDICA BAC BSI 检测能够在 8 小时内直接从原发性全血样本中识别出广泛的细菌，这可能有助于及时给予适当的治疗。
