新时代检验医学发展定位与思考

检验医学作为医学科学的重要支撑学科,在疾病早期诊断、病情监测、预后判断与风险评估等方面发挥着重要作用。21世纪是数字信息时代,高新检测技术、计算机科学及互联网大数据等,为检验医学的发展带来巨大的机遇与挑战,新时代下如何借助信息科技革命实现检验医学新发展是检验工作者面临的重要课题。该文回顾检验医学的发展历程,重点关注检验医学在新时代的发展定位及未来发展方向,以求开创检验医学发展新局面。     

Efficacy of recombinant Marek’s disease virus vectored vaccines with computationally optimized broadly reactive antigen (COBRA) hemagglutinin insert against genetically diverse H5 high pathogenicity avian influenza viruses

The genetic and antigenic drift associated with the high pathogenicity avian influenza (HPAI) viruses of Goose/Guangdong (Gs/GD) lineage and the emergence of vaccine-resistant field viruses underscores the need for a broadly protective H5 influenza A vaccine. Here, we tested experimental vector herpesvirus of turkey (vHVT)-H5 vaccines containing either wild-type clade 2.3.4.4A-derived H5 inserts or computationally optimized broadly reactive antigen (COBRA) inserts with challenge by homologous and genetically divergent H5 HPAI Gs/GD lineage viruses in chickens. Direct assessment of protection was confirmed for all the tested constructs, which provided clinical protection against the homologous and heterologous H5 HPAI Gs/GD challenge viruses and significantly decreased oropharyngeal shedding titers compared to the sham vaccine. The cross reactivity was assessed by hemagglutinin inhibition (HI) and focus reduction assay against a panel of phylogenetically and antigenically diverse H5 strains. The COBRA-derived H5 inserts elicited antibody responses against antigenically diverse strains, while the wild-type-derived H5 vaccines elicited protection mostly against close antigenically related clades 2.3.4.4A and 2.3.4.4D viruses. In conclusion, the HVT vector, a widely used replicating vaccine platform in poultry, with H5 insert provides clinical protection and significant reduction of viral shedding against homologous and heterologous challenge. In addition, the COBRA-derived inserts have the potential to be used against antigenically distinct co-circulating viruses and future drift variants.     

Cytologic and histologic samples from patients infected by the novel coronavirus 2019 SARS-CoV-2: An Italian institutional experience focusing on biosafety procedures

The 2019 coronavirus pandemic, which started in Wuhan, China, spread around the globe with dramatic and lethal effects. From the initial Chinese epicenter, the European diaspora taxed the resources of several countries and especially those of Italy, which was forced into a complete social and economic shutdown. Infection by droplets contaminating hands and surfaces represents the main vehicle of diffusion of the virus. The common and strong efforts to contain the pandemic have relevant effects on the management of samples from histopathology laboratories. The current commentary reports and focuses on the protocols and guidelines in use at a large tertiary Italian hospital that accordingly are proposed for adoption in Italian laboratories as a potential model for national guidelines for the coronavirus emergency.     

桂枝芍药知母汤对类风湿性关节炎患者实验室指标和免疫功能的影响

目的:探讨桂枝芍药知母汤对类风湿性关节炎患者实验室指标和免疫功能的影响。方法:选取2014年12月至2016年12月南京中医药大学附属南京市中西医结合医院收治的类风湿关节炎患者110例作为研究对象，按照随机数字表法分为对照组和观察组，每组55例。对照组采用常规西医治疗，观察组在对照组的基础上联合桂枝芍药知母汤治疗，2组均治疗1个月。比较2组临床效果、临床症状改善情况、实验室指标及免疫功能指标水平；统计2组不良反应发生率。结果:观察组总有效率为92.73%，高于对照组（78.18%，P<0.05）。与治疗前比，治疗1个月后，2组握力均增大，且观察组大于对照组（P<0.05）；2组晨僵时间、20 m步行时间均缩短，且观察组短于对照组（P<0.05）；2组关节压痛数、关节肿胀数、ESR、MPV、PDW及血清CRP、血浆IgA、IgG、IgM、RF水平均降低，且观察组低于对照组（P<0.05）；2组血清C3水平均升高，且观察组高于对照组（P<0.05）。治疗期间，观察组不良反应发生率为0.00%，低于对照组（10.91%，P<0.05）。结论:桂枝芍药知母汤治疗类风湿性关节炎，可改善患者实验室指标，增强免疫功能，提高疗效，安全性较高。     

Relationship between biological variation and delta check rules performance

ObjectivesThe performance of delta check rules has been considered to be dependent on the biological variation characteristics of the analyte of interest. The assumed relationships have not been formally studied. The mathematical relationship between biological variation and delta check rules is explored in this study.Design and methodsFrom the mathematical model for absolute difference delta check, the threshold for specificity and sensitivity are observed to be normalized differently. For specificity, the threshold is normalized by the within-subject biological variation (expressed as a coefficient of variation, ${\mathit{CV}}_i$), whereas for sensitivity the threshold is normalized by the between-subject biological variation (expressed as a coefficient of variation, ${\mathit{CV}}_g$). This highlights the different roles the two biological variations play in affecting the absolute difference distribution for correct and switched patient samples. Analogous to absolute difference delta checks, for relative difference delta checks, the expressions for specificity and sensitivity are scaled by ${\mathit{CV}}_i$ and ${\mathit{CV}}_g,$ respectively. However, the expressions are independent of ${\mu }_g$(the average of the population).ResultsA comparison between the mathematical model and empirical/ historical laboratory data obtained from patients was conducted for both absolute and relative difference delta checks. In general it was found that the specificity obtained from the historical laboratory data was less than the model predicted values, while on the other hand, good correspondence was obtained between the experimental sensitivity and predicted sensitivity.ConclusionsThe difference in within-subject biological variation in different patients may contribute to the observed discrepancy in predicted and empirical delta check performance.