Emergency Medicine, Ochsner Medical Center, New Orleans, Louisiana.
Esoteric Testing/R&D Laboratory, Tampa General Hospital, Tampa, Florida.
J Emerg Med. 2020 May;58(5):785-796. doi: 10.1016/j.jemermed.2019.11.028. Epub 2020 Jan 23.
Bacteremia causes a major worldwide burden, in terms of financial and productivity costs, as well the morbidity and mortality it can ultimately cause. Proper treatment of bacteremia is a challenge because of the species-dependent response to antibiotics. The T2Bacteria Panel is a U.S. Food and Drug Administration-cleared and culture-independent assay for detection of bacteremia, including common ESKAPE pathogens-Escherichia coli, Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, and Pseudomonas aeruginosa-and provides species identification in as little as 3.6 h directly from blood.
Our aim was to evaluate the T2Bacteria assay performance and potential to affect patient care in the emergency department (ED).
ED patients from a Louisiana and Florida center were enrolled as part of the T2Bacteria Panel clinical study, which was prospective and noninterventional. Blood samples for blood culture (BC) and T2Bacteria were matched in time and anatomic location.
Data from 137 ED patients were evaluated. Relative to BC, T2Bacteria showed 100% positive percent agreement and 98.4% negative percent agreement. In addition, for species on the T2Bacteria Panel, the T2Bacteria assay detected 25% more positives associated with infection, and on average identified the infectious species 56.6 h faster. The T2Bacteria assay covered 70.5% of all species detected by BC. Finally, relative to actual care, the T2Bacteria assay could have potentially focused therapy in 8 patients, reduced time to a species-directed therapy in 4 patients, and reduced time to effective therapy in 4 patients.
In this ED population, the T2Bacteria assay was a rapid and sensitive detector of bacteremia from common ESKAPE pathogens and showed the theoretical potential to influence subsequent patient therapy, ranging from antibiotic de-escalation to faster time to effective therapy.
菌血症会造成重大的全球负担，包括经济和生产力成本，以及最终可能导致的发病率和死亡率。由于抗生素的物种依赖性反应，菌血症的适当治疗是一个挑战。T2Bacteria 检测试剂盒是一种获得美国食品和药物管理局批准的、不依赖培养的菌血症检测方法，可检测包括常见 ESKAPE 病原体在内的细菌，如大肠杆菌、屎肠球菌、金黄色葡萄球菌、肺炎克雷伯菌和铜绿假单胞菌，并在 3.6 小时内直接从血液中提供物种鉴定。
我们旨在评估 T2Bacteria 检测试剂盒的性能及其在急诊科（ED）影响患者治疗的潜力。
路易斯安那州和佛罗里达州中心的 ED 患者作为 T2Bacteria 检测试剂盒临床研究的一部分被纳入研究，该研究为前瞻性、非干预性研究。血液样本用于血液培养（BC）和 T2Bacteria 检测，时间和解剖位置相匹配。
对 137 名 ED 患者的数据进行了评估。与 BC 相比，T2Bacteria 显示出 100%的阳性百分比一致性和 98.4%的阴性百分比一致性。此外，对于 T2Bacteria 检测试剂盒上的物种，T2Bacteria 检测试剂盒检测到与感染相关的阳性菌的数量增加了 25%，并且平均提前 56.6 小时鉴定出感染性物种。T2Bacteria 检测试剂盒覆盖了 BC 检测到的所有物种的 70.5%。最后，与实际治疗相比，T2Bacteria 检测试剂盒可以潜在地为 8 名患者集中治疗，为 4 名患者缩短至针对特定物种的治疗时间，并为 4 名患者缩短至有效治疗的时间。
在该 ED 人群中，T2Bacteria 检测试剂盒是一种快速而敏感的常见 ESKAPE 病原体菌血症检测方法，具有潜在的影响后续患者治疗的理论能力，范围从抗生素降级到更快的有效治疗时间。
