Ramanathan Aishwariya, Marimuthu Anusuya, Abayasekara Lalanika M, Jeyaratnam Thurga, Chandrasekharan Vishvanath, Perera Jennifer, Ramasubramanian Venkatasubramanian, Sethuraman Nandini, Samarasinghe Sumudu, Peiris Varuna, Gnanam Vaz S
Micro Genomics India Pvt Ltd, 16, Wallace Garden First street, Thousand lights, Chennai, 600006, India.
Credence Genomics, No 12 3/2, Sunethredevi road, Kohuwela, Nugegoda, 10250, Sri Lanka.
Heliyon. 2024 Jul 14;10(14):e34538. doi: 10.1016/j.heliyon.2024.e34538. eCollection 2024 Jul 30.
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.
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.
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.
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.
根据全球统计数据,脓毒症每年导致五分之一的人死亡。近期研究表明,脓毒症发病率至少占所有重症监护病房(ICU)入院病例的35%,且死亡率很高,尤其是在存在合并症的情况下。考虑到可能的多种微生物感染、共生菌和环境污染物等因素,准确诊断致病微生物一直是一项挑战。传统技术如培养、自动化培养系统,甚至更新的物种特异性聚合酶链反应(PCR)或薄膜阵列,都难以克服这些挑战。Bactfast®和Fungifast®检测以及集成工作流程基于下一代测序技术,能够区分感染病原体与污染物和共生菌。考虑到各种样本中的共生菌和污染物,其独特的精确确定病原体的能力,以及极高的灵敏度,可能使其因其全面的覆盖范围和速度而成为无法解决的ICU脓毒症诊断选择工具。本研究的目的是评估Bactfast®和Fungifast®在ICU环境中作为最后一公里诊断工具的应用。
本研究考虑了四个重症监护病房的使用情况。传统检测主要基于培养,在印度钦奈设有ICU的医院的各个综合微生物学设施中进行。NABL认可的实验室Micro Genomics(印度)私人有限公司被设立为下一代测序的中央处理设施,以运行Bactfast®和Fungifast®检测。由微生物学家和传染病医生组成的多学科顾问团队对490个样本的结果进行了回顾性相关性分析。
使用Bactfast®检测建立的诊断工作流程的灵敏度为94.1%,特异性为86.6%。与2017年发表的数据相比,Bactfast®中病原体的鉴定情况更好,这通过与临床确认的正相关性得到体现。尽管Fungifast®的特异性很高,达到99.4%,但在490个样本中,真菌培养仅有12个样本呈阳性。因此,得出结论,需要基于多种技术并使用更多真阳性样本对真菌进行进一步研究以评估该检测。
Bactfast®可以无偏差地鉴定样本中的病原体。将其作为危及生命的ICU脓毒症的诊断方式引入,可降低死亡率和发病率。尽管Fungifast®的初步结果令人鼓舞,但需要进一步研究以获取更多关于检测灵敏度的信息。