关于我国体外诊断试剂监督管理改革的建议

本文综述了美国、欧盟、日本、中国目前对体外诊断产品（试剂）监督管理的现状以及我国存在的问题。并根据我国具体情况提出了对体外诊断试剂监督管理的改革建议。     

How to Right a Wrong: Empirically Evaluating Whether Victim,Offender, and Assault Characteristics can Inform Rape Kit Testing Policies

ABSTRACT

Hundreds of thousands of previously untested sexual assault kits (SAKs) have been uncovered in police property storage facilities across the United States, representing a national failure in institutional response to sexual assault. Faced with this discovery, jurisdictions must now decide if and how they should test these kits. Some stakeholders have suggested prioritizing kits for testing by victim, offender, or assault characteristics, based on the belief that these characteristics can predict the likely utility of DNA testing. However, little research has examined the empirical merits of such prioritization. To address this gap in the literature and inform SAK testing policies, we randomly sampled 900 previously untested SAKs from Detroit, MI. The sampled SAKs were submitted for DNA testing, and eligible DNA profiles were entered into Combined DNA Index System (CODIS), the federal DNA database. Police records associated with each SAK were coded for victim, offender, and assault characteristics, and logistic regression analyses were conducted to test whether these characteristics predict which SAKs yield DNA profiles that match (“hit”) to other criminal offenses in CODIS. Testing this sample of previously-untested SAKs produced a substantial number of CODIS hits, but few of the tested variables were significant predictors of CODIS hit rate. These findings suggest that testing all previously-unsubmitted kits may generate information that is useful to the criminal justice system, while also potentially addressing the institutional betrayal victims experienced when their kits were ignored.     

HPV6b L1蛋白在昆虫细胞中的表达及其作为特异性诊断抗原的初步研究

目的：研究人乳头瘤病毒6b结构蛋白（HPV6b L1)在昆虫细胞系统的表达及其作为特异性诊断抗原的可行性,为HPV感染的血清学诊断及基因工程疫苗研究作准备。方法：采用HPV6b L1重组杆状病毒感染sf-9昆虫细胞制备HPV6b L1,经氯化梯度离心纯化,Western blot分析及电镜观察鉴定;用1μg、5μg和20μg三种剂量免疫小鼠,以检测小鼠血清抗体反应;并用HPV6b L1作为诊断抗原检测HPV感染者（尖锐湿疣及宫颈癌）和健康对照者共112例血清特异性抗体。结果：HPV6b L1在昆虫细胞中得到表达,并可自行组装形成VLPs,且予1μg剂量免疫小鼠就能产生阳性血清抗体反应,HPV6b L1 VLPs特异性抗体对HPV6感染的敏感性和特异性分别为78．6％和97．1％。结论：HPV6b L1 VLPs具较强的免疫原性和抗原性,血清中检测到的HPV6b L1抗体对HPV6感染具较高的特异性,可进一步用于HPV感染的血清学诊断及防治尖锐湿疣的基因工程疫苗研究。     

NOVA16急诊生化分析仪试剂包中A、R、H液的研制与应用

目的 研制ＮＯＶＡ１６全自动急诊生化分析仪试剂包中Ａ,Ｒ,Ｈ液。方法 根据电极法测定血浆（或全血）中Ｎａ＾＋、Ｋ＾＋、Ｃｌ＾－、ＴＣＯ２、Ｇｌｕ、Ｕｒｅａ、Ｃｒ等物质浓度（活度）和红细胞压积（Ｈｅｍａｔｏｃｒｉｔ,Ｈｃｔ）的原理及标准液配制的有关要求,配制类似血浆水的Ａ液、ＣＯ２释放液Ｈ及参比液Ｒ。结果 自配Ａ,Ｒ,Ｈ液与原装试剂的主要理化指标：ｐＨ、渗透压、电极斜率、线性范围及试剂的稳定性等方面     

国内外结核菌聚合酶链反应试剂盒的临床检测结果比较

目的用相同标本比较国内外结核菌聚合酶链反应诊断试剂盒的临床检测效果,并初步探讨结核菌聚合酶链反应荧光诊断试剂盒在临床应用中定量检测结核菌数量的可行性。方法用聚合酶链反应技术,荧光探针杂交技术、酶联免疫反应技术以及常规细菌学方法检测并经双盲编号的84份临床痰标本和8份含痰结核菌标准品。结果在59例结核病患者痰标本中,国产PCR-酶联免疫检测试剂盒与PCR荧光试剂盒分别检出26例阳性和24例阳性,国外试剂盒检出24例阳性;在25例非结核病患者痰标本中,国产PCR-酶联免疫检测试剂盒与PCR荧光试剂盒分别检出21例真阴性和24例真阴性,国外试剂盒检出23例真阴性;细菌学各级别检查结果与PCR荧光检测CT值不呈递减关系。结论国内外结核菌聚合酶链反应诊断试剂盒对临床标本的检测结果无显著性差异;结核菌聚合酶链反应荧光诊断试剂盒尚不能定量检测痰标本中的结核菌数量,有待更多的临床数据加以证实。     

4个Y-miniSTR基因座荧光标记复合扩增体系的建立

目的:构建DYS456,DYS392,DYS439,Y-GATA-H4等4个Y-mini STR基因座复合扩增体系,评价其检测敏感度、数据库兼容性和对降解检材的分型能力。方法:设计4个Y-mini STR的引物,用FAM、JOE、ROX、TAMRA分别标记其上游引物,构建复合扩增体系。利用本体系的引物扩增稀释过的Y23试剂盒的ladder,制备等位基因分型标准物。比较该体系与Promega Power PlexY23试剂盒在普通检材、降解检材的分型能力、敏感度和分型结果。结果:同一样本体系分型结果和商业化试剂盒Y23 STR分型结果相同,4个Y-mini STR复合扩增体系和对降解检材的分型成功率更高,敏感度一致,具有数据库兼容性。结论:本研究中的4个Y-mini STR复合扩增体系对降解检材的检测具有应用价值,敏感性较好,具有数据库兼容性,可以作为对降解检材分型时商业化试剂盒的补充。     

胎儿染色体非整倍体无创基因检测试剂盒的临床验证

目的 验证胎儿染色体非整倍体(T21、T18、T13)基因检测试剂盒(联合探针锚定连接测序法)在临床检测上的准确性和有效性.方法 选择广东省东莞市妇幼保健院的孕妇外周血样本,采用胎儿染色体非整倍体(T21、T18、T13)基因检测试剂盒通过联合探针锚定连接测序法检测,并将结果与临床诊断金标准染色体核型分析结果或出生随访结果作对比.对灵敏度、特异性、总符合率和一致性系数Kappa值进行评价,以验证该试剂盒在临床检测上的准确性和有效性.结果 共完成有效样本389例,测序法检出T21阳性6例,T18和T13均未检出阳性,与染色体核型分析结果相符,检测为阴性共383例,经电话随访至出生未发现非整倍体胎儿.统计分析结果显示,测序法与核型分析法总符合率为100％,Kappa=1(≥0.8),其中检测T21的灵敏度、特异性、阳性预测值、阴性预测值均为100％;检测T18和T13的特异性、阴性预测值均为100％.结论 采用试剂盒通过联合探针锚定连接测序法检测T21、T18、T13的结果准确度高且方法安全,可以在临床上推广使用.     

Emergency anaphylaxis protocols: A cross-sectional analysis of general practice surgeries and pharmacies in both the urban and rural setting in Ireland

Background: The incidence of anaphylaxis appears to be increasing worldwide with cases in the community outnumbering those in the hospital setting. General practice (GP) surgeries and pharmacies, based in the community, are often the first point of contact for many patients suffering from anaphylaxis.

Objectives: To determine if studied GP surgeries and pharmacies have an anaphylaxis protocol on site and have access to an anaphylaxis kit; to explore GP’s and pharmacists’ personal experiences with management of anaphylaxis.

Methods: A cross-sectional, questionnaire-based study was performed examining anaphylaxis protocols in a sample of general practices and pharmacies from some counties in Ireland. This consisted of a sample from rural and urban settings. The study commenced in October 2014.

Results: Nineteen of 24 GPs (79%) and 9 (29%) pharmacies had an anaphylaxis protocol (P?<?0.001). Twenty-four (100%) GP practices and 12 pharmacies (39%) surveyed had an anaphylaxis kit on site. Twelve GPs (50%) had treated a patient with anaphylaxis in the surgery while 8 (33%) had treated a patient in the community. One pharmacist (3%) had witnessed anaphylaxis in practice. Two pharmacies and one GP had been contacted by local businesses to alert them to a case of anaphylaxis.

Conclusion: In contrast to national and international guidelines only 79% of GPs and 29% of pharmacies in this study from Ireland had an anaphylaxis protocol onsite.     

HIV自我快速检测试剂使用现状调查

目的了解目前网络销售的艾滋病病毒(HIV)自我快速检测试剂使用现状。方法针对自检过程涉及的各环节设计调查问卷;2019年6-9月,通过HIV感染高危人群社区组织微信群、QQ群和微博招募HIV自我快检试剂使用者,通过微信和QQ在电脑或手机端完成问卷。结果共6042人完成网络问卷调查,年龄中位数为26岁(15~88岁),大学及以上73.2%(4422人),全职工作者4013人(66.4%)。最近一次自检时,选用指尖血快检试剂的占45.5%,选择指尖血+口腔黏膜渗出液(OMT)组合试剂者占26.9%。离退人员选用OMT检测试剂的占32.2%,选用尿液试剂的占7.7%。绝大多数人认为保护隐私是HIV自检最主要的优点,缺乏相关咨询服务是HIV自检最主要的缺点。HIV自检发现阳性的比例为7.0%(421/6042),使用指尖血、OMT和尿液检测试剂检出阳性的比例分别为8.8%(241/2752)、6.9%(55/798)和4.9%(36/739)。50.4%自检后将试剂和生活垃圾一起丢弃。结论HIV自检发现了相当比例的阳性者,快检试剂的选用和处理存在一定的知识和风险控制需求,建议利用网络向潜在自检者提供检测前咨询,同时基于社区加强检测后结果解释、废弃物处理等宣传教育,做好自检后咨询及与后续诊疗服务的紧密连接。     

Effect of the bracket types on microbial colonization and periodontal status

Objective:To evaluate the effect of different bracket types on the levels of Streptococcus mutans (SM) and Lactobacillus (LB) in saliva, in plaque, and on the periodontal condition.Materials and Methods:Forty patients aged 14 to 16 years, who had Angle Class I malocclusion with minimal crowding, were nonsmokers, were without systematic disease, and did not use antibiotics or oral mouth rinses during the 3-month period before the study were randomly selected. The patients were subdivided into two groups with random allocation of bracket type: conventional brackets (CB; Avex Mx, OPAL orth.) with steel wire ligature or self-ligating brackets (SLB; F1000, Leone S.p.A.). Microbial and periodontal records were obtained before bonding (T₁) and 1 month after bonding (T₂). Microbial samples were collected from the stimulated saliva and the plaque from the labial surfaces of the upper and lower lateral incisors. To estimate the number of colony-forming units of SM and LB, Dentocult SM and LB kits were used. The plaque index (PI), gingival index (GI), and pocket depth (PD) values were recorded to evaluate the periodontal condition. Paired t-test and Mann-Whitney U-test were used to compare the groups statistically.Results:No significant differences occurred in SM or LB colonization between the groups. In the SLB group, PI, GI, and PD values increased significantly (P < .05). A greater increase was found in PD value in the SLB group (0.98 mm) compared with the CB group (0.04 mm; P < .05).Conclusions:The F1000 SLB do not have an advantage over Avex Mx CB with respect to periodontal status and colonization of SM and LB.