LAMP法检测超级细菌NDM-1基因

目的建立超级细菌NDM-1基因的LAMP检测方法。方法根据目前Genbank上公布的超级细菌NDM-1基因序列,交由商业性的公司化学合成NDM-1全基因,然后以PCR、酶切及测序鉴定基因合成是否成功;再以LAMP法扩增NDM-1基因重组质粒,电泳观察扩增是否成功。结果经证实化学合成NDM-1基因是成功的;之后进行的LAMP法扩增NDM-1基因也是成功的。结论成功建立了LAMP法检测超级细菌NDM-1基因的方法,为超级细菌的检测提供了一种可用的方法。     

针对MSM人群的HIV-1早期感染检测策略研究

目的建立针对男男性行为人群（MSM）艾滋病病毒（HIV）感染的高敏感检测策略,减少窗口期漏检。方法收集来自黑龙江、辽宁、内蒙古、宁夏和青海省（自治区）的MSM人群专项调查样本,分别用中国现行的HIV抗体常规检测策略、新检测策略一、新检测策略二和新检测策略三进行检测,对常规策略与3种新策略的检测结果进行对比、分析。结果11023份调查样本中,常规策略[三代酶联免疫吸附试验（ELISA）＋蛋白免疫印迹试验（WB）]检出的抗体阳性、阴性和不确定标本分别为282份、10716份和25份;新策略一（四代ELISA＋WB）检出的抗体阳性、阴性和不确定标本分别为282份、10676份和65份;新策略二（三代ELISA＋WB＋集合核酸）检出的核酸阳性,抗体阳性、阴性和不确定标本分别为28份、282份、10688份和25份;新策略三（四代ELISA＋WB＋集合核酸）检出的核酸阳性,抗体阳性、阴性、不确定标本分别为13份、282份、10663份和65份。常规策略、新策略一至三的检测敏感性分别为90．96％、90．96％、100％和95．16％,新策略二和新策略三的检测敏感性显著高于常规策略（P〈0．05）,且新策略对早期及急性HIV感染者的检测能力优于常规策略。结论针对MSM人群的HIV新检测策略,可以减少早期及急性HIV感染者的漏检,应根据实验室检测能力和样本量尽快在该人群中推广使用。     

Contribution of Cardiorespiratory Fitness to the Obesity Paradox

Until recently, cardiorespiratory fitness (CRF) has been overlooked as a potential modifier of the inverse association between obesity and mortality (the so-called obesity paradox), observed in patients with known or suspected cardiovascular (CV) disease. Evidence from five observational cohort studies of 30,104 patients (87% male) with CV disease indicates that CRF significantly alters the obesity paradox. There is general agreement across studies that the obesity paradox persists among patients with low CRF, regardless of whether adiposity is assessed by body mass index, waist circumference, or percentage body fat. However, among patients with high CRF, risk of all-cause mortality is lowest for the overweight category in some, but not all, studies, suggesting that higher levels of fitness may modify the relationship between body fatness and survival in patients manifesting an obesity paradox. Further study is needed to better characterize the joint contribution of CRF and obesity on mortality in diverse populations.     

How to: ECOFFs—the why,the how,and the don'ts of EUCAST epidemiological cutoff values

BackgroundIdentifying the MIC wild-type distribution and its delineation of species targeted for receiving antimicrobial agent breakpoints is an important first step for determining clinical breakpoints. Having the main responsibility in the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for characterizing the wild-type distributions and setting epidemiological cut-off values (ECOFFs), we explain the why, the how, and frequent misconceptions of wild-type MIC distributions and ECOFFs.ObjectivesTo clarify how wild-type MIC distributions and ECOFFs for agents and important target organisms are defined and determined and why these are important tools in microbiology, as well as to point to common misunderstandings and inappropriate use.SourcesThe EUCAST database of >40 000 MIC distributions; publications addressing the definition of wild-type MIC distributions, and ECOFFs in bacteria and fungi; and the EUCAST Standard Operating Procedure 10 Documents published by the European Centre for Disease Control and the European Food Safety Agency.ContentThe rationale for defining wild-type distributions and ECOFFs is explained. Setting breakpoints that bisect wild-type MIC distributions leads to poor methodological reproducibility and poor correlation between clinical outcome and susceptibility testing results. The methods applied by EUCAST to select distributions for aggregation and website display are described, highlighting the importance of incorporating data from multiple sources and methods. The methods used by EUCAST to estimate ECOFFs are outlined. Finally, the common misunderstandings of these processes are addressed.ImplicationsThe international community needs to agree on the phenotypic definitions of wild-type distributions. Systematic methods for developing and applying ECOFFs are essential to the conduct of phenotypic antimicrobial susceptibility testing and interpretation, which will remain the dominant laboratory method for the foreseeable future.     

A six-sigma approach to stability testing

The following defines stability testing in the diagnostic and pharmaceutical industries as a process which, depending on the manufacturer's current approach, may contain many opportunities for improvement. Statistical thinking and six sigma concepts will enhance stability testing process capability and lead to higher confidence in the data. Tools for set up and the rationale behind them are provided to assist in establishing appropriate criteria and volume of testing.     

The JRC Nanomaterials Repository: A unique facility providing representative test materials for nanoEHS research

The European Commission has established a Nanomaterials Repository that hosts industrially manufactured nanomaterials that are distributed world-wide for safety testing of nanomaterials. In a first instance these materials were tested in the OECD Testing Programme. They have then also been tested in several EU funded research projects. The JRC Repository of Nanomaterials has thus developed into serving the global scientific community active in the nanoEHS (regulatory) research. The unique Repository facility is a state-of-the-art installation that allows customised sub-sampling under the safest possible conditions, with traceable final sample vials distributed world-wide for research purposes. This paper describes the design of the Repository to perform a semi-automated subsampling procedure, offering high degree of flexibility and precision in the preparation of NM vials for customers, while guaranteeing the safety of the operators, and environmental protection. The JRC nanomaterials are representative for part of the world NMs market. Their wide use world-wide facilitates the generation of comparable and reliable experimental results and datasets in (regulatory) research by the scientific community, ultimately supporting the further development of the OECD regulatory test guidelines.     

一台引起放射性皮肤损伤的介入放射学设备检测结果调查与分析

目的 通过调查和分析一台引起放射性皮肤损伤的介入放射学设备的质量控制检测结果,为介入放射学程序运行过程中的放射防护最优化提供建议。方法 调取一台引起患者放射性皮肤损伤的介入放射学设备近3年的5次质量控制检测报告,比较检测结果的差异并分析存在的问题。结果 对于“透视受检者入射体表空气比释动能率典型值”项目,3家机构5次检测结果在6.08~24.89 mGy/min之间,符合相关标准的要求;不同曝光模式(普通剂量率透视模式、高剂量率透视模式、电影模式)和不同帧率对受检者入射体表空气比释动能率和透视防护区检测平面上周围剂量当量率检测结果影响较大;操作该设备的介入医生对设备的曝光模式了解不足,手术后未记录患者剂量。结论 通过对介入放射学设备的调试可显著降低患者剂量;建议在标准修订时增加参考点累积剂量或剂量面积乘积准确性指标的检测;加强对介入医生和技师的专业培训,使其充分了解设备不同曝光模式对患者和术者剂量的影响。     

医疗器械检验检测现状及发展趋势探索

目的 该文旨在迎接我国医疗器械检验检测行业的新业态和新挑战,探索行业的未来发展方向。方法 在概述医疗器械检验检测行业现状的基础上,采用专家访谈和线上问卷的方式,调研40家医疗器械检验检测机构及相关企事业单位,重点关注科技创新能力和形式、行业发展瓶颈等重要问题。结果 通过整理和分析调研数据,得出行业发展的5个积极趋势：完善机构整体布局,加强区域特色中心建设;完善第三方合作研究组织和第三方评审机构的准入与监管机制;鼓励科技创新,优化人才队伍,赋能检验检测技术高质量发展;构建医疗器械安全监管信息化共享平台;加强在用医疗器械设备的安全监测。创新之处 采用专家访谈和循证研究的方法,获取客观可靠的数据,为行业发展趋势的研究和探索提供了有力的依据。