不同溯源的两台血凝仪测定纤维蛋白原方法学比较

目的比较SYSMEX CA6000与STACompact2台血凝仪测定纤维蛋白原的结果,了解其偏倚的可接受性。方法根据美国临床实验室标准化委员会（NCCLS）EP9-A2文件,用2台血凝仪同时测定40例患者的纤维蛋白原,检查离群点并进行直线相关分析,计算医学决定水平处的预期偏倚。结果2台仪器测定结果均无离群点。直线回归方程为矿=0．8516X-0．0487,r=0．992。3个医学决定水平处预期偏倚分别为0．093、0．197、0．791g／L。结论纤维蛋白原的3个医学决定水平处预期偏倚95％置信区间下限均低于允许偏倚,SYSMEXCA6000测定结果与STACompact测定结果相当,偏倚可接受。     

应用HIMSS 6级标准构建药品追溯体系

分析样本医院住院药房345种药品中国药品电子监管码标注情况及现有药品可追溯情况,结合药品是否需要拆零,依据HIMSS 6级及JCI标准,建立院内药品闭环管理体系,构建院内药品追溯体系。认为结合中国药品电子监管码构建院内药品追溯体系,是保障药品安全供应的重要途径。     

2013-2016年广东省登革病毒血清I型分布特征

目的 对2013-2016年广东的登革病毒血清I型序列进行分子流行病学分析,研究血清I型登革病毒在广东省的流行特征。方法 分离获得2013-2016年登革病毒血清I型序列,建立全球登革病毒血清I最大似然树,预测第2簇病毒的进化速率、共祖位置;使用PAML软件计算选择压力。结果 2013-2016年的广东序列分别聚类在11簇分支中,其中8簇为基因I型毒株、1簇基因IV型毒株、2簇基因V型毒株,且与东南亚国家分离的序列聚类在一起。第2簇病毒表现出一定的独特性,最大置信树以及时空动态图显示这簇株系最早是由泰国传入广州,之后又在广东地区流行。第2簇病毒的相对进化速率要比文献报道的DENV-1基因I型的进化速率要大,但该簇病毒的序列不存在正选择压力。结论 广东地区流行的登革病毒主要是从东南亚国家输入,同时发现一簇疑似本地化的株系,具有部分本地化的特征,包括:跨年传播、独立成簇,但还需要更多的证据去判定登革热是否已形成本地化。     

Adventitious agents and live viral vectored vaccines: Considerations for archiving samples of biological materials for retrospective analysis

Vaccines are one of the most effective public health medicinal products with an excellent safety record. As vaccines are produced using biological materials, there is a need to safeguard against potential contamination with adventitious agents. Adventitious agents could be inadvertently introduced into a vaccine through starting materials used for production. Therefore, extensive testing has been recommended at specific stages of vaccine manufacture to demonstrate the absence of adventitious agents. Additionally, the incorporation of viral clearance steps in the manufacturing process can aid in reducing the risk of adventitious agent contamination. However, for live viral vaccines, aside from possible purification of the virus or vector, extensive adventitious agent clearance may not be feasible.In the event that an adventitious agent is detected in a vaccine, it is important to determine its origin, evaluate its potential for human infection and pathology, and discern which batches of vaccine may have been affected in order to take risk mitigation action. To achieve this, it is necessary to have archived samples of the vaccine and ancillary components, ideally from developmental through to current batches, as well as samples of the biological materials used in the manufacture of the vaccine, since these are the most likely sources of an adventitious agent. The need for formal guidance on such vaccine sample archiving has been recognized but not fulfilled. We summarize in this paper several prior major cases of vaccine contamination with adventitious agents and provide points for consideration on sample archiving of live recombinant viral vector vaccines for use in humans.     

Hémovigilance et sécurité transfusionnelle en opération extérieure

The French military blood institute (FMBI) is the only military blood supplier in France. FMBI operates independently and autonomously under the Ministry of Defense's supervision, and accordingly, to the French, European and NATO technical and safety guidelines. FMBI is in charge of the collection, preparation and distribution of blood products to supply transfusion support to armed forces, especially during overseas operations. In overseas military, a primary physician is responsible for haemovigilance in permanent relation with an expert in the FMBI to manage any adverse reaction. Additionally, traceability of delivered or collected blood products during overseas operation represents a priority, allowing an appropriate management of transfusion inquiries and assessment of practices aiming to improve and update procedures and training. Transfusion safety in overseas operation is based on regular and specific training of people concerned by blood supply chain in exceptional situation.     

Data management plans: the missing perspective

The National Institutes of Health requires data sharing plans for projects with over five hundred thousand dollars in direct costs in a single year and has recently released a new guidance on rigor and reproducibility in grant applications. The National Science Foundation outright requires Data Management Plans (DMPs) as part of applications for funding. However, there is no general and definitive list of topics that should be covered in a DMP for a research project. We identified and reviewed DMP requirements from research funders. Forty-three DMP topics were identified. The review uncovered inconsistent requirements for written DMPs as well as high variability in required or suggested DMP topics among funder requirements. DMP requirements were found to emphasize post-publication data sharing rather than upstream activities that impact data quality, provide traceability or support reproducibility. With the emphasis equalized, the forty-three identified topics can aid Data Managers in systematically generating comprehensive DMPs that support research project planning and funding application evaluation as well as data management conduct and post-publication data sharing.     

消化内镜清洗消毒全程质量追溯管理的探讨

目的探讨消化内镜清洗消毒全程质量追溯管理的方法,确保消化内镜清洗消毒的质量和有效追溯。方法使用后的消化内镜按标准化流程进行回收、清洗、消毒、干燥、储存,对其全过程进行相关记录,实施全程质量追溯管理。结果 2006年1月-2010年1月共实施120 906例次消化内镜的清洗消毒,经医院感染管理与疾病控制科,每季度对消毒后消化内镜进行生物学监测的抽查,均消毒合格,记录具有可追溯性。结论对消化内镜清洗消毒全程进行质量追溯管理的方法,有效地确保了消化内镜清洗消毒的质量,并对于预防与控制医院感染具有举证的重要依据。     

自建系统谷草／谷丙转氨酶量值溯源性研究

目的确保患者标本在日立自建系统与罗氏配套检测系统上谷草／谷丙转氨酶的检测结果可溯源到同一测量基准。方法通过日立自建系统与罗氏配套系统对新鲜混合血清测定结果进行对比分析,找出日立自建系统存在的系统偏差,井对日立系统校准值进行修订,修订后对日立系统进行二次校准,然后进一步进行两系统对比分析。结果第一次对比两系统偏差超过1／2CLIA’88规定的最大允许误差范围,第二次两系统偏差小于1／4CLIA’88规定的最大允许误差范围。结论通过对比分析从而对自建系统校准血清的校准值重新赋值,是实现自建系统检测结果准确性和可溯源的有效途径。     

提高生化检测结果准确性的研究进展

近年来随着检验医学的发展和对检测质量要求的提高,人们开始认识和关注检测系统的重要性。目前,国际上特别强调使用固定组合的检测系统——"封闭系统",其检验结果具有溯源性和可比性。然而,国内实验室大多使用不同的检测系统(封闭系统、开放系统)测定相同检验项目,致使开放系统检验结果的准确性、溯源性与封闭系统的结果不一致性。这是一个极大的现实问题,也是目前检验界关注和讨论的热点。现就如何提高开放检测系统生化结果的准确性予以综述。     

临床化学检验结果的误差分析及可比性探讨

[目的]分析临床化学检验结果误差来源，探索减少误差提高结果可比性的方法。[方法]运用数学模型纠正实验误差，参照ISO17025标准为检验结果进行溯源性分析和不确定度赋值。[结果]运用数学公式可以修正实验误差，检验结果带有不确定度更具可比性。[结论]修正实验误差和不确定度赋值使检验结果具有世界范围的可比性。