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.     

粪便中A群轮状病毒检测在小儿急性腹泻中的价值

目的：探讨粪便中A群轮状病毒检测在小儿急性腹泻中的价值。方法回顾性分析2013年12月-2015年12月在长春市儿童医院检验科进行A群轮状病毒检测的急性腹泻患儿298例,对检测结果进行分析总结。结果298例急性腹泻患儿中A群轮状病毒阳性率为32.2%,6个月~2岁患儿的阳性率为47.8%,与0~6个月(21.7%),2~5岁(15.9%)相比差异有统计学意义(P<0.05),0~6个月和2~5岁阳性率相比差异无统计学意义(P>0.05),男孩患儿阳性率为31.4%,女孩患儿阳性率为29.7%,相比差异无统计学意义(P>0.05)。结论粪便中A群轮状病毒检测在小儿急性腹泻的诊断中意义重大,值得在临床上推广应用。     

血清分离后室温放置24小时内多肽质谱的变化

目的探讨血清分离后室温放置24h内多肽质谱的变化,为确立血清多肽质谱分析最适时间提供参考。方法募集6名志愿者(男性2名,女性4名,平均年龄30岁)分别采集静脉血,离心分离血清后,根据在室温下放置的时间(0h、2h、6h、10h、24h)分装血清冻存并分成5组待测。用弱阳离子磁珠提取多肽,用Clin-TOF平台进行检测,通过BioExplorer软件和SPSS 22.0进行多肽峰的比较。结果5个不同时间组共出峰58个,5个多肽峰差异有统计学意义(P<0.05),在5组峰强度最大的前10个多肽峰中,8个均相同,且峰强无差异(P>0.05);6h组和10h组正态分布的血清多肽峰最多(51个),全峰强度6h组最高(1599499);峰强度大于300的血清多肽峰数为6h组最高(24.7±1.37),峰强累积值为6h组最高(132674);根据正态分布多肽峰个数、全峰强度、峰强大于300的多肽峰数、差异峰4049.9m/z的峰强度这4个因素综合评价,6h组得分最高。结论在室温条件放置24h之内血清多肽变化不足以影响分析,最优的检测时间是采血分离血清后室温放置6h,在这一条件下进行质谱检测,出峰均一性最佳,且峰强度最大,较易获得阳性结果。     

Guidelines for the Validation and Use of Immunoassays for Determination of Introduced Proteins in Biotechnology Enhanced Crops and Derived Food Ingredients

Recent advancements in agricultural biotechnology have created a need for analytical techniques to determine introduced proteins in crops enhanced through modern biotechnology techniques. These proteins are expressed in plant tissues and may be present in food ingredients. Immunoassays are ideally suited for protein detection and may be used as both quantitative and threshold methods. Microplate ELISA and lateral flow devices are two of the most commonly used immunoassay formats for agricultural biotechnology applications. This paper provides general background information and a discussion of criteria for the validation and application of immunochemical methods to the analysis of proteins introduced into plants and food ingredients using biotechnology methods. It is the result of a collaborative effort of members of the Analytical Environmental Immunochemical Consortium. This collaborative effort represents the combined expertise of several organizations to reach consensus on establishing guidelines for the validation and use of immunoassays. Further, the paper offers developers and users a consistent approach to adopting the technology as well as aid in producing accurate and meaningful results.     

复方氨基酸注射液细菌内毒素检查法的研究

复方氨基酸注射液(18AA)对细菌内毒素检查有抑制作用,通过稀释的方法可排除其干扰,其最大非干扰浓度为12.5mg·ml-1(总氮基酸)。结果表明,选择适宜灵敏度的鲎试剂,18AA的热原检查可用细菌内毒素检查法代替家兔法。     

中国4省艾滋病单阳家庭配偶告知方式和影响因素调查分析

目的 了解艾滋病单阳家庭配偶告知方式(感染者本人告知/由他人告知)的情况及可能的影响因素.方法 采用自行设计的调查问卷,以面对面的调查方式,对我国河南、云南、广西、四川地区的艾滋病单阳家庭进行调查,内容主要包括人口学信息、艾滋病相关知识与行为、配偶告知的方式等;并结合艾滋病综合防治数据信息系统的资料收集调查对象的感染途径等信息.结果 共调查艾滋病单阳家庭感染者及其配偶770对,其中414名感染者(53.77%)自报是本人将感染状况告知配偶,由医务人员告知的344人(44.68%).影响告知方式的因素有性别、民族、文化程度和感染途径.女性、汉族、文化程度高者、既往采供血感染者,更倾向于由感染者本人进行配偶告知.结论 民族和传播途径是告知方式的重要影响因素,应重点加强以性传播和/或静脉注射吸毒传播为主的地区以及少数民族地区的配偶告知工作.     

基层单位怎样选择交叉配血试验方法

临床输血在抢救患者的生命过程中起着非常重要的作用.在输血之前,需要鉴定患者的ABO血型和Rh血型,还必须做交叉配血试验,这是确保病人安全输血必不可少的.过去传统方法是盐水交叉配血,它只能检测完全抗体,近年来为了临床输血更安全,要求配血时采用两种方法进行,达到取长补短,发挥高效的作用.我科采用盐水交叉配血和凝聚胺试验交叉配血联合进行,收到了较好的效果.现报告如下.     

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。     

比较大蒜对不同真菌抑制活性的研究

目的:检测大蒜提取液对青霉菌、白假丝酵母菌及新型隐球菌的抑制作用。方法:采用K-B法(纸片扩散法),测量大蒜提取液对受试菌种的抑菌环直径大小。结果:大蒜对以上3种真菌均有较强的抑制作用,且以新型隐球菌的抑菌效果最优,白假丝酵母菌次之,青霉菌居后。