某种人类免疫缺陷病毒I型核酸定量检测试剂盒的性能评估

目的对某种人类免疫缺陷病毒I型（HI-1）核酸定量检测试剂盒（PCR．荧光探针法）的临床应用性能进行评估。方法收集不同HIV感染状态人群的血液样品共计109份,分别使用HIV-1被评估试剂与参比试剂的核酸定量检测试剂盒进行平行对比试验。统计学处理使用Kappa值、砰和Bland—Ahman模型。结果被评估试剂检测结果相对于参比试剂,检测结果的总符合率为97．25％（95％CI：92．17％-99．43％）,Kappa值为0．92（P〈0．001）,一致性强度为最强。109例样本中,均在被评估试剂与参比试剂定量检测范围内的样本为84例,两种试剂盒检测结果的回归分析表现出较强的相关性（R2=0．8536）。使用Bland—Altman模型比较两种试剂检测结果的差异均值,结果显示对于未进行抗病毒治疗的HIV感染者样本两种试剂检测结果具有较好的一致性。结论被评估试剂和参比试剂对同一份血浆样本检测结果具有较好的定性符合程度和较强的相关性,对HIV感染者样本两试剂检测结果有较强的定量一致性。     

两种人类免疫缺陷病毒定量检测试剂的评价研究

目的比较罗氏公司与我国圣湘生物公司的Ⅰ型人类免疫缺陷病毒(HIV-1)病毒载量定量检测试剂的性能。方法首先,对国产新开发的HIV-1试剂定量线性范围和灵敏度做了初步评估,然后,收集227例疑似HIV感染者样本血浆,分别用两个公司的试剂进行检测,采用Kappa检验分析两种试剂检测的一致性;并对于线性检测范围内的阳性样本,采用Bland-Altman和Pearson法分析比较两种试剂病毒载量检测的一致性和相关性。结果圣湘生物研发的HIV-1检测试剂可测定的线性定量范围为50IU/ml-1.00E+08IU/ml,灵敏度达到50IU/ml;两种试剂检测227例样本,阳性一致性为100.00%,阴性一致性为98.15%,总一致性为99.56%,其Kappa值为0.988,P=0.012,表明两种试剂在定性检测上具有很好的一致性;两种试剂对病毒载量定量检测的线性相关性系数R=0.775、P=0.022,仅2.31%的点(4个样本)在95%的一致性界限外。结论国产新型HIV-1定量检测试剂具有很好的检测线性范围和灵敏度,与Roche Cobas TaqMan RT-PCR HIV-1V2.0试剂对227份临床样本的定量检测结果对比,两者具有很好的线性相关性和一致性。     

国内某人类免疫缺陷病毒I型(HIV-1)核酸检测试剂盒的自动化应用性能评估

目的对国内某人类免疫缺陷病毒Ⅰ型(HIV-1)核酸定量检测试剂盒的自动化应用性能进行评估。方法收集150份血液样品,用待评试剂和参比试剂及自动化设备进行双盲检测。2种试剂定性结果用符合率和卡方检验等统计方法分析;2种试剂的定量结果用相关性分析、回归分析等统计方法分析。结果 2种试剂检测结果的总体符合率为100.00%,Kappa值为1.00。2种试剂盒定量检测结果的相关性分析显示2种试剂检测结果一致,配对t检验显示2种试剂具有等效性。结论待评试剂和参比试剂对同一血液样本检测结果具有较高的定性符合率、较强相关性以及定量一致性。     

2013-2015年全国HIV-1病毒载量检测能力验证方法的比较

目的 通过分析2013-2015年全国HIV-1病毒载量检测能力验证（VQA-PT）结果,了解法国bioMerieux公司的NucliSens EasyQ HIV-1 v2.0（EasyQ）、美国Siemens Healthcare Diagnostics公司VERSANT HIV-1 RNA 3.0 assay（bDNA）、美国罗氏分子诊断公司COBAS AmpliPrep/COBAS TaqMan HIV-1 test（Taqman）、美国Abbott Molecular公司Abbott Real Time HIV-1 Kit（M2000）、中山大学达安基因股份有限公司和东北制药集团辽宁生物医药有限公司的HIV-1核酸定量检测试剂盒（国产试剂）5种方法检测结果之间的定量换算关系,为不同方法检测HIV-1病毒载量结果的横向比较提供参考。方法 参照《HIV-1病毒载量测定及质量保证指南》（2013版）的要求,由中国CDC性病艾滋病预防控制中心参比实验室统一组织全国HIV-1的VQA-PT。采用多中心回溯性研究方法,2013-2015年共计考核6次,考核实验室155家,涉及阳性样本22个,相应结果2 954个。针对每个阳性样本的所有结果,首先转换为对数值,而后按照检测方法分类,计算对数值的均值,获得不同方法检测相同样本的一组数据。对最终获得的22组数据进行Bland-Altman分析和线性回归分析。结果 Bland-Altman分析显示,EasyQ及bDNA与Taqman的一致性为100%,M2000及国产试剂与Taqman的一致性≥ 90%。回归分析结果显示,EasyQ、bDNA、M2000及国产试剂检测结果在数值上与Taqman之间存在相应的换算关系（P<0.01）。结论 对于我国HIV-1感染者,使用不同病毒载量检测方法获得的结果一致性良好,不同方法的结果之间可以转换,进而对治疗效果进行分析评价。     

血液唾液和尿液HIV抗体快速检测及免疫印迹试剂评估

目的对Calypte公司血液、唾液和尿液3种HIV-1／2抗体快速检测试剂与尿液和血液两种HIV-1抗体免疫印迹试剂进行评估，为引进检测性能良好的试剂提供参考。方法平行采集84位HIV阳性感染者指尖血、唾液、尿液和静脉血标本，分别用Calypte公司的3种快速试剂进行HIV-1／2抗体检测，并与梅里埃血液ELISA参比试剂检测结果比较；尿液和静脉血标本分别用Calypte公司的两种免疫印迹试剂进行检测，并与GerieLabs公司的血液免疫印迹参比试剂检测结果进行比较。结果血液、唾液和尿液快速检测试剂的敏感性分别为100％、100％和96．42％，3种快速试剂检测结果与梅里埃血液ELISA检测结果一致性分别为100％、100％和96．42％；血液和尿液HIV-1WB试剂检测结果与GeneLabs参比试剂的一致性为100％。结论Calypte公司3种HIV-1／2抗体快速检测试剂和两种HIV-1抗体免疫印迹试剂与相应的参比试剂有很好的一致性。     

滤纸片干血斑在HIV-1 BED-CEIA新发感染检测方法中的应用

目的 探讨在HIV-1 BED-CEIA新发感染检测中应用滤纸片干血斑的价值。方法 研究纳入22个艾滋病自愿咨询检测（VCT）中心10 226名咨询者血浆及干血斑样本作为目标实施HIV抗体检测，对通过免疫印迹法（WB）明确诊断为350例HIV感染患者的血浆样本及干血斑样本需同时实施BED-CEIA检测，观察滤纸片干血斑在HIV-1 BED-CEIA新发感染检测方法中稳定性、重复性，对两种样本检测结果存在的差异性进行对比。结果 在HIV-1 BED-CEIA新发感染检测中应用滤纸片干血斑稳定性、重复性较高，重复性R2值可高达0.955 1。350例HIV感染患者样本检测结果中，其中295例患者样本被同时评估为长期感染，53例患者样本被同时评估为新近感染，两种样本对HIV BED-CEIA新发感染评估判定结果呈一致性（R2值=0.95），一致性为99.42%。血浆样本及干血斑样本得到不同结果，样本An值均处于临界值附近（P<0.05）。结论 在HIV-1BED-CEIA新发感染检测中应用滤纸片干血斑的价值较高，检测结果稳定性、重复性较好，虽然部分样本检测结果存在一定的差异，但与血浆样...     

一种血液艾滋病病毒抗体免疫印迹试剂的现场评估

目的对Cambridge血液艾滋病病毒（HIV）-1抗体免疫印迹（WB）试剂进行现场评估并考核其在不同的HIV感染状态的人群中确认试验检测的敏感性和特异性.方法选取不同的现场,分别采集不同的HIV感染状态人群的血液样品,共计645份.经酶联免疫吸附试验（ELISA）检测后,分别使用Cambridge血液HIV-1抗体WB试剂盒和HIV blot 2.2 HIV-1/2型WB确认试剂盒进行平行对比试验.结果在已知既往HIV感染者中,Cambridge血液WB与Genelabs WB检测结果均为阳性,在此人群中上述2种确认试剂的敏感性均为100%.在398例HIV抗体ELISA检测为阴性的人群中,Cambridge血液WB试验23例为不确定;Genelabs血液WB试验86例为不确定,在此类人群中上述2种确认试剂的特异性分别为94.22%（375/398）和78.39%（312/398）.结论Cambridge血液HIV-1抗体WB试剂盒与Genelabs诊断公司的HIV blot 2.2 HIV-1/2型WB试剂盒的试验结果对比,在特异性方面前者优于后者.     

国产化学发光法弓形虫IgM抗体诊断试剂结果评价

摘要:目的　评价国产化学发光法弓形体抗体诊断试剂应用价值。方法　本次临床试验以国产的弓形虫IgM抗体测定试剂盒（化学发光法）作为评价试剂,以意大利DiaSorin的弓形虫IgM抗体检测试剂盒（化学发光法）为比对试剂,对临床血浆样本进行一致性评价。结果　两种试剂同时共计检测352例血浆样本,其中评价试剂与比对试剂定性检测结果同为阴性的样本数为308例,阴性符合率为98.72%（95%CI:96.75%～99.50%）;检测结果同为阳性的样本数为40例,阳性符合率为100%（95%CI:91.24%～100%）;总符合率为98.86%（95%CI:88.05%～100%）。一致性分析Kappa系数＝0.946（95%CI:0.893～0.999）,P＜0.05,显示两种试剂具有较高的一致性（Kappa＞0.8）。对4例不符样本进行了第三方验证,其结果显示,比对试剂检测为阴性、评价试剂与第三方试剂检测为阳性的样本有1例;评价试剂检测为阳性、比对试剂与第三方试剂检测为阴性的样本有3例;评价试剂的阳性预测值为93.18%,阴性预测值为100%。结论　两种试剂具有较高的一致性（Kappa＞0.8）。评价试剂能够满足医疗卫生机构用于诊断弓形体感染的要求。     

7种新型冠状病毒核酸检测试剂变异株检测性能比对分析

目的 评价常用的7种新型冠状病毒（2019-nCoV）核酸检测试剂（荧光定量PCR法）对2019-nCoV变异株的检测性能。方法 收集已知2019-nCoV核酸检测阳性的变异株样本,包括Alpha变异株、Beta变异株、 Eta变异株样本。比较7种2019-nCoV核酸检测试剂的灵敏度和特异度,采用Kappa系数对7种检测试剂的检测结果与基因测序结果进行一致性评价。结果 7种检测试剂对3种变异株的灵敏度均>85%,特异度均为100%,Kappa系数均>0.8。结论 7种2019-nCoV核酸检测试剂在检测现有流行变异株时均具有较高灵敏度和特异度,未造成脱靶和漏检,且与基因测序结果相比一致性好。     

一种国产化学发光法检测HSV1/2型及HSV-2型抗体的临床比对研究

目的评价国产化学发光法检测单纯疱疹病毒HSV1/2型及HSV-2型抗体,和市售进口同类产品进行临床比对试验,了解该产品在临床使用中的效果。方法收集华西医院送检检测HSV 1/2型IgG抗体350例、HSV 1/2型IgM抗体350例及HSV-2型IgG抗体样本353例,以进口HSV1/2 IgG、HSV1/2 IgM及HSV-2 IgG试剂作为比对系统,分别评价国产化学发光法HSV1/2 IgG、HSV1/2 IgM及HSV-2 IgG试剂盒的诊断性能,结果不一致的标本运用第三方试剂进行复核。采用Kappa一致性检验分析定性结果的一致性,运用Bland-Altman分析定量数据的结果一致性。结果与进口试剂相比,HSV1/2 IgG评价试剂的总符合率是99.71%,Kappa值是0.986,P0.05;HSV1/2 IgM评价试剂的总符合率是98.57%,Kappa值0.972,P0.05;HSV-2 IgG评价试剂的总符合率是98.30%,Kappa值为0.971,P0.05;此外,Bland-Altman分析结果显示,对于HSV1/2 IgG和HSV-2 IgG 2个定量项目,国产试剂和进口试剂之间量值差值(偏倚)均处于95%的一致限内,符合方法学比对一致性的统计学要求(5%)。结论国产试剂盒与进口试剂盒在检测HSV1/2型及HSV-2型抗体方面具有良好的一致性,可以满足临床需求。     

The human drama of genetics: 'hard' and 'soft' media representations of inherited breast cancer

This paper examines media coverage of 'breast cancer genetics', and explores its implications for public understanding. We present a content analysis of coverage in British newspapers and look at a variety of popular forms, including women's magazines, television soap opera and radio drama. Genetic/inherited risk receives a great deal of coverage across a wide range of media formats and outlets. Much of this attention has focused on individuals from 'high risk families' and dilemmas around prophylactic mastectomies. Through examining media coverage, combined with interviews with media personnel and their sources, we show why this story proved so attractive to the media and highlight the different production values which influence coverage. Finally, we introduce preliminary findings from focus group discussions to demonstrate how such 'human interest' framing has engaged audience attention and influenced public understandings. The paper concludes by highlighting the implications for analysing, predicting, and engaging with, media representations of science.     

The occurrence of antimicrobial substances in toilet,sink and shower drainpipes of clinical units: A neglected source of antibiotic residues

Antibiotics represent one of the most important drug groups used in the management of bacterial infections in humans and animals. Due to the increasing problem of antibiotic resistance, assurance of the antibacterial effectiveness of these substances has moved into the focus of public health. The reduction in antibiotic residues in wastewater and the environment may play a decisive role in the development of increasing rates of antibiotic resistance. The present study examines the wastewater of 31 patient rooms of various German clinics for possible residues of antibiotics, as well as the wastewater of five private households as a reference.To the best of our knowledge, this study shows for the first time that in hospitals with high antibiotic consumption rates, residues of these drugs can be regularly detected in toilets, sink siphons and shower drains at concentrations ranging from 0.02?μg·L^?1 to a maximum of 79?mg·L^?1. After complete flushing of the wastewater siphons, antibiotics are no longer detectable, but after temporal stagnation, the concentration of the active substances in the water phases of respective siphons increases again, suggesting that antibiotics persist through the washing process in biofilms. This study demonstrates that clinical wastewater systems offer further possibilities for the optimization of antibiotic resistance surveillance.     

Worker education in the primary prevention of occupational dermatoses

This paper reports the evaluation of a skin care education programmeconducted on a fine chemicals manufacturing site where over1,000 employees are located. Approximately 60% are involvedin chemical manufacture. Over a 12 month period production staffreceived training in prevention of occupational dermatoses linkedto a site-wide poster initiative. The incidence of new casesof occupational dermatoses fell from 0.055 (70 cases in 1,277employees) to 0.021 (27 cases in 1,277 employees) before andafter the intervention respectively (p<0.0001). After otherfactors such as chemicals handled, observer bias and changesin reporting related to socioeconomic climate were taken intoaccount it is concluded that this study demonstrates the importanceof worker education as a tool for primary prevention of disease.Training materials such as video and poster presentations maybe effectively used in the chemical manufacturing industry asan adjunct to prevention and control of exposure to substanceshazardous to the skin. Such methods may also be used in otherindustries where there are significant risks of dermatoses.     

Regional Variation in Travel-related Illness acquired in Africa,March 1997–May 2011

To understand geographic variation in travel-related illness acquired in distinct African regions, we used the GeoSentinel Surveillance Network database to analyze records for 16,893 ill travelers returning from Africa over a 14-year period. Travelers to northern Africa most commonly reported gastrointestinal illnesses and dog bites. Febrile illnesses were more common in travelers returning from sub-Saharan countries. Eleven travelers died, 9 of malaria; these deaths occurred mainly among male business travelers to sub-Saharan Africa. The profile of illness varied substantially by region: malaria predominated in travelers returning from Central and Western Africa; schistosomiasis, strongyloidiasis, and dengue from Eastern and Western Africa; and loaisis from Central Africa. There were few reports of vaccine-preventable infections, HIV infection, and tuberculosis. Geographic profiling of illness acquired during travel to Africa guides targeted pretravel advice, expedites diagnosis in ill returning travelers, and may influence destination choices in tourism.     

Self-reported health problems among Swedish miners one year after unemployment

Unemployment is considered to be a public health concern sincedeterioration in the health of the unemployed is often anticipated.However, for some groups, such as miners, unemployment mightimprove health due to a cessation of potentially harmful occupationalexposures. This study evaluates the health of 79 miners in oneSwedish iron-ore mine, and 226 age-matched controls from thegeneral population, during one year after the closure of themine. The participants received a questionnaire regarding medicalhistory and subjective symptoms at the beginning of the studyperiod, and after one year. Statistically significant negativeeffects on self-reported health attributable to unemploymentwere not found, although neuropsychiatric symptoms were morecommon among the unemployed miners. The miners reported a statisticallysignificant improvement in grip force (p=0.031). They had asignificantly higher prevalence of symptoms associated withmining related exposures when compared with the population controls;pain in the upper extremities [relative risk (RR)=2.27, 95%confidence interval (Cl)=1.44–3.59), back pain (RR=1.84;Cl=1.237–2.75), vasospastic disease of the fingers (RR=2.05;Cl=1.18–3.57) and obstructive respiratory symptoms (attacksof dyspnea and wheezing: RR=3.67; Cl=1.167–11.6).     

Excès de cas humains et animaux de tularémie en France au cours de l’hiver 2007–2008 : émergence ou phénomène isolé ?

Context

Tularemia is a zoonosis affecting humans and hares in France. We describe the results of surveillance in both species, in 2007 and 2008.

Methods

Human tularemia cases are mandatorily notifiable in France since 2003. In hares, surveillance relies on volunteer hunter associations in all districts of the country. Data from mandatory reports and volunteer surveillance in 2007/2008 were analyzed and compared with previous results.

Results

In 2007/2008, 144 cases were reported in humans and 117 cases in hares. This was a 100% increase compared to previous years. Human cases differed from those of previous years only by the frequency of contact with breeding animals. Human cases without any documented risk exposure were also more frequent.

Conclusion

An increase of tularemia cases occurred in 2007/2008 in both species. Complementary studies are needed to identify the species reservoir in France to understand the causes of this peak of cases.     

Fatigue and health in a seafaring population

Background Occupational fatigue is relatively common withinthe general population and has been linked to reduced performance,injury and longer term ill-health. Despite growing acknowledgementof this problem in the maritime sector, little research hasbeen conducted into the risk factors, prevalence and consequencesof seafarers' fatigue. Aims To examine the prevalence of fatigue among seafarers, identifypotential risk factors and assess possible links with poor performanceand ill-health. Methods Cross-sectional questionnaire survey of seafarers workingin the offshore oil support, short-sea and deep-sea shippingindustries. A number of tools were used including the fatiguesubscale of the profile of fatigue-related symptoms, the CognitiveFailures Questionnaire, the General Health Questionnaire andthe SF36 General Health scale. Results In all, 1855 questionnaires were completed giving anoverall response rate of 20%. Fatigue symptoms were associatedwith a range of occupational and environmental factors, manyunique to seafaring. Reporting a greater number of risk factorswas associated with greater fatigue [e.g. OR = 2.53 (1.90–3.35)for those with three or four risk factors and OR = 9.54 (6.95–13.09)for those with five or more risk factors]. There was also astrong link between fatigue and poorer cognitive and healthoutcomes, with fatigue the most important of a number of riskfactors, accounting for 10–14% of the variance. Conclusions Seafarers' fatigue could impact on safety withinthe industry and may be linked to longer term individual ill-health.It can only be addressed by considering how multiple factorscombine to contribute to fatigue.     

The design of hazard risk assessment matrices for ranking occupational health risks and their application in mining and minerals processing

Two hazard risk assessment matrices for the ranking of occupational health risks are described. The qualitative matrix uses qualitative measures of probability and consequence to determine risk assessment codes for hazard-disease combinations. A walk-through survey of an underground metalliferous mine and concentrator is used to demonstrate how the qualitative matrix can be applied to determine priorities for the control of occupational health hazards. The semi-quantitative matrix uses attributable risk as a quantitative measure of probability and uses qualitative measures of consequence. A practical application of this matrix is the determination of occupational health priorities using existing epidemiological studies. Calculated attributable risks from epidemiological studies of hazard-disease combinations in mining and minerals processing are used as examples. These historic response data do not reflect the risks associated with current exposures. A method using current exposure data, known exposure-response relationships and the semi-quantitative matrix is proposed for more accurate and current risk rankings.     

Occupational health hazards in mining: an overview

This review article outlines the physical, chemical, biological, ergonomic and psychosocial occupational health hazards of mining and associated metallurgical processes. Mining remains an important industrial sector in many parts of the world and although substantial progress has been made in the control of occupational health hazards, there remains room for further risk reduction. This applies particularly to traumatic injury hazards, ergonomic hazards and noise. Vigilance is also required to ensure exposures to coal dust and crystalline silica remain effectively controlled.