■根据全球统计数据,脓毒症每年造成5人死亡。在最近的研究中,脓毒症发病率至少占所有ICU入院的35%,并且死亡率很高。尤其是在并存的情况下。挑战是准确诊断致病生物,考虑到可能的多微生物感染等因素,共生和环境污染物。传统技术,如文化,自动化培养系统或甚至更新的物种特异性PCR或胶片阵列这些挑战难以克服。Bactfast®和Fungifast®分析以及集成的工作流程基于下一代测序,能够区分感染病原体的污染和共生。查明确切病原体的独特能力,考虑到各种样品的共生和污染,具有极高的灵敏度,由于其全面的覆盖范围和速度,可能使其成为非解决ICU脓毒症的诊断选择工具.这项研究的目的是评估Bactfast®和Fungifast®作为ICU环境中最后一英里诊断工具的使用。
■这项研究是考虑进入四个重症监护病房(ICU)进行的。遗留测试,主要是在文化方面,是在重症监护病房所在医院的各种综合微生物设施进行的,在钦奈,印度。NABL认可的实验室MicroGenomics(India)PvtLtd,被建立为下一代测序的中央处理设施,以运行Bactfast®和Fungifast®测定。由微生物学家组成的多学科顾问团队对490个样本的结果进行了回顾性分析,和传染病医生。
■使用Bactfast®测定法建立的诊断工作流程提供了94.1%的灵敏度和86.6%的特异性。与2017年发布的数据相比,Bactfast®中的病原体鉴定更好,这通过与临床确认的正相关反映出来。尽管Fungifast®特异性很高,99.4%,490个样本中只有12个样本对真菌培养呈阳性。因此,结论是,需要对基于多种技术的真菌进行进一步研究,并需要更多的真实阳性样本来评估测试。
■Bactfast®可以在没有任何偏差的情况下鉴定样品中的病原体。将其作为危及生命的ICU败血症的诊断方式引入可以降低死亡率和发病率。虽然Fungifast®的初步结果令人鼓舞,但需要进一步的研究才能获得更多关于测试灵敏度的信息。
UNASSIGNED: Sepsis claims 1 in 5 lives annually as per global statistics. Sepsis incidence in recent studies represents at least 35 % of all ICU admissions and has a high mortality rate, especially in the presence of co-existing morbidities. The challenge has been to accurately diagnose the causative organism, considering factors such as possible polymicrobial infections, commensals and environmental contaminants. Legacy techniques such as culture, automated culture systems or even newer species-specific PCR or film array these challenges difficult to overcome. The Bactfast® and Fungifast® assays along with the integrated workflow is based on next generation sequencing and have the ability to demarcate infecting pathogen from contamination and commensal. The unique ability to pinpoint the exact pathogen, considering the commensal and contamination in a variety of samples, with an extremely high sensitivity could lead it to be a tool of diagnostic choice for non-resolving ICU sepsis due to its comprehensive coverage and speed. The aim of this study was to evaluate the use of Bactfast® and Fungifast® as a last mile diagnostic tool in a ICU setting.
UNASSIGNED: This study was carried out considering access to four intensive care units (ICU). Legacy testing, mostly done on culture, was conducted at the various integrated microbiology facilities of the hospitals where the ICUs were located, in Chennai, India. NABL accredited laboratory Micro Genomics (India) Pvt Ltd, was established as the central processing facility for next generation sequencing to run the Bactfast® and Fungifast® assay. Co-relation of results for 490 samples was done retrospectively by a multi-disciplinary team of consultants which comprised of microbiologists, and infectious disease physicians.
UNASSIGNED: The diagnostic workflow established with the Bactfast® assay provided a sensitivity of 94.1 % and specificity of 86.6 %. Identification of pathogens in Bactfast® was better when compared to the data published in 2017, as reflected by positive co-relation with clinical confirmation. Although the Fungifast® specificity was high, at 99.4 %, only 12 samples were positive on fungal culture out of 490 samples. Therefore, it was concluded a further study for fungi based on multiple technologies with more true positive samples is required to evaluate the test.
UNASSIGNED: Bactfast® can identify pathogens in a sample without any bias. Its introduction as diagnostic modality in life threatening ICU sepsis could reduce mortality and morbidity. Although the initial results of Fungifast® are encouraging a further research is required for more information on test sensitivity.