Department of Internal Medicine and Therapeutics, Unit of Rheumatology, University of Pavia and IRCCS Policlinico S. Matteo Foundation, 27100, Pavia, Italy.
Neonatal Immunology Laboratory, UOC Neonatology and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Mol Biol Rep. 2020 Jan;47(1):363-368. doi: 10.1007/s11033-019-05138-2. Epub 2019 Oct 22.
Neonatal sepsis is a life-threatening condition and its early diagnosis is crucial for infant survival. Identifying responsible pathogens is a key step. Blood culture (BC) is the gold standard, but more rapid and specific diagnostic methods are needed. We evaluated the reliability and utility of 3 h turnaround time diagnostic molecular kit, "EuSepScreen lattanti "CE IVD marked, (EuSepScreen lattanti, Eurospital Spa Trieste, Italy) specifically targeted to detect 4 pathogens in neonatal sepsis: Klebsiella pneumoniae (KP), Escherichia coli (EC), Streptococcus agalactiae (GBS), and Lysteria monocytogenes. We evaluated 69 neonates, 40 full term and 29 preterm infants, with suspected bloodstream infection, who, overall the routine clinical procedures, were tested using the molecular kit. Kit results were compared to BC outcomes. Nineteen cases for early onset sepsis (EOS) were evaluated, 2 of them resulted positive to a molecular kit and to BC (both for GBS and EC). In the 50 cases of suspected late onset sepsis (LOS), 7 infants reported positive and coincident results to both the methods, in 3 further cases the molecular kit identified pathogens (EC) in neonates with negative BC result; in 10 cases BC revealed etiological pathogens exceeding the molecular kit possibility of identification. In case of EOS, results of the molecular kit were coincident to these of BC, but available in 3 h turnaround time, which is an advantage, so the kit may actually be an "add-on tool" for EOS, with reference to EC and GBS, but a larger study with a greater number of EOS cases are needed to validate its usefulness in the NICU. Regarding LOS the restricted panel of identifiable microorganisms failed to provide timely information for sepsis diagnosis, highlighting the need of enlarged number microorganisms for the diagnosis of LOS.Trial registration number: NCT03884894.
新生儿败血症是一种危及生命的疾病，早期诊断对婴儿的生存至关重要。确定致病病原体是关键步骤。血培养（BC）是金标准，但需要更快速和更特异的诊断方法。我们评估了具有 3 小时周转时间的诊断分子试剂盒的可靠性和实用性，该试剂盒名为“EuSepScreen lattanti ”CE IVD 标记（EuSepScreen lattanti，Eurospital Spa Trieste，意大利），专门用于检测新生儿败血症中的 4 种病原体：肺炎克雷伯菌（KP）、大肠杆菌（EC）、无乳链球菌（GBS）和李斯特菌（LM）。我们评估了 69 名疑似血流感染的新生儿，其中 40 名足月，29 名早产。根据常规临床程序，对这些新生儿使用分子试剂盒进行了检测。将试剂盒结果与 BC 结果进行比较。共评估了 19 例早发性败血症（EOS）病例，其中 2 例分子试剂盒和 BC 均为阳性（均为 GBS 和 EC）。在 50 例疑似晚发性败血症（LOS）病例中，7 例患儿两种方法均呈阳性且结果一致，在另外 3 例中，分子试剂盒在 BC 结果阴性的新生儿中鉴定出病原体（EC）；在 10 例中，BC 发现了分子试剂盒无法鉴定的病原体。在 EOS 中，分子试剂盒的结果与 BC 结果一致，但周转时间为 3 小时，这是一个优势，因此该试剂盒实际上可能是 EOS 的“附加工具”，针对 EC 和 GBS，但需要更大规模的研究和更多的 EOS 病例来验证其在 NICU 中的有用性。对于 LOS，可识别微生物的受限面板未能及时提供败血症诊断信息，这突出表明需要扩大 LOS 诊断所需的微生物数量。试验注册号：NCT03884894。
