新型冠状病毒患者标本采集技术专家共识

标本采集在促进临床诊断新型冠状病毒感染中发挥着重要的角色。为规范临床医务人员进行新冠肺炎患者标本采集技术行为,减少医务人员职业暴露,提高送检标本的合格率和标本质量,笔者团队严格按专家共识制订规范要求,完成文献检索、文献评价及总结和两轮专家函询会,最终形成了《新冠肺炎患者标本采集技术专家共识》,并顺利通过中华护理学会团体标准委员会的审核。本共识提出了新冠肺炎患者标本采集技术的适用范围、术语和定义、缩略语、标本采集基本要求、操作程序、及标本采集期间意外事件的应急处理,供临床参考。     

新型冠状病毒（COVID-19）感染的肺炎患者进行 超声影像学检查的应用

新型冠状病毒( 2019-nCoV) 感染的肺炎是由新型冠状病毒引起的以肺部炎性病变为主的疾病,还可引起肠道、肝脏和神经系统的损害和相应症状,严重者可出现多器官功能衰竭、脓毒症、肾功能衰竭、感染性心内炎等危急并发症。2019-nCov肺炎自2019年12起自武汉爆发流行,其病毒传染力强,潜伏期长,至今蔓延到全国,确诊病例已有4万余人。目前检测和排查疑似病例,进行早期治疗和隔离,是眼下的当务之急。而检查手段有患者分泌物的核酸检测,一是对呼吸道标本或血标本实时荧光RT-PCR检测新型冠状病毒核酸阳性,二是呼吸道标本或血液标本病毒基因测序与已知的新型冠状病毒高度同源。而核酸检测假阴性的患者也较多。超声对于2019-nCov重症肺炎患者多出现双侧或单侧胸腔积液、胸膜下出现病灶、肺组织实变等,相对比与CT检查更加便捷快速,也有便于临床上胸腔积液的引流进行实时定位,在检测和排查2019-nCov肺炎患者和处理2019-nCov肺炎患者临床并发症的过程中起到很好的辅助作用。     

新型冠状病毒肺炎患者痰标本采集及送检的安全管理策略

总结新型冠状病毒肺炎感染病区患者痰标本采集及送检的安全管理经验。包括对病区布局和病区环境严格消毒灭菌、规范化培训护理人员、制订规范采集标本措施、安全及时送检流程。从收治新冠肺炎患者开始累计采集痰标本1749份,40名护理人员参与操作,标本采集及送检率达到100%,无标本污染,未发生标本丢失和相关人员感染事件。     

四川省新型冠状病毒相关实验室检测及生物安全操作专家共识

2019年底湖北武汉爆发了新型冠状病毒感染,并迅速蔓延到全国及国外100余国家和地区。截至2020年3月初,我国新型冠状病毒肺炎确诊病例已超过八万例,导致三千多人死亡。新型冠状病毒肺炎的相关实验室检测,包括核酸检测,为该病的诊断和治疗提供重要依据。为提高四川省新型冠状病毒肺炎相关实验室检验流程的规范化,并保障我省检验人员安全,四川省临床检验中心联合四川省质控中心、四川省医学会检验专委会,组织我省检验领域专家,制订新型冠状毒肺炎的相关实验室检验和生物安全防护专家共识。该共识内容包括适用范围、新型冠状病毒肺炎的病原学及流行病学特点,实验室安全原则,生物安全防护,标本的采集、转运、标接收和前处理,检测流程,检测后标本及相关废弃物处理,生物安全意外事故的处理等11个方面的内容,旨在指导四川省临床实验室建立新型冠状病毒相关实验室检测和实验室生物安全标准流程。     

新型冠状病毒肺炎检验标本闭环管理经验分享

目的运用检验标本闭环管理理念并依据感染防控要求对新型冠状病毒肺炎及疑似患者标本转运流程进行规范,保障标本安全及时送达隔离实验室,防止感染扩散,提高工作效率。方法依据豫卫医[2020]6号文下发的《检验标本院内转运感染防控流程》,构建我院标本闭环管理方案并对医护人员进行培训后实施。结果采用检验标本闭环管理,对100例确诊及疑似新型冠状病毒肺炎标本进行转运,无标本延时、标本丢失、标本引起的感染等不良事件发生。结论应用规范化的标本闭环信息管理系统能够保证新型冠状病毒肺炎标本安全转运并提高工作效率。     

系统性红斑狼疮导致血清新型冠状病毒IgM和IgG抗体假阳性1例分析

新型冠状病毒肺炎已经成为人类疾病史上的第六次大流行疾病,中华人民共和国国家卫生健康委员会发布的《新型冠状病毒肺炎诊疗方案(试行第七版)》,在原有对新型冠状病毒肺炎确诊需要核酸检测或测序基础上增加了血清学检测作为依据,即新型冠状病毒特异性IgM和IgG抗体阳性,或新型冠状病毒特异性IgG抗体由阴性转为阳性或恢复期较急性期4倍及以上升高也可确诊,并一直沿用。血清学检测由于检测条件容易实现、速度快、可以大量检测、患者接受度高等优点,与核酸检测联合成为新型冠状病毒肺炎确诊的一种重要方法,多篇文献也肯定了血清学抗体检测在临床诊断和流行病学方面的价值[1-2],但临床应用中血清学抗体检测假阳性造成对诊断干扰的案例鲜有报道。本例患者入院时在新型冠状病毒核酸不能及时检测情况下先行血清抗体检测,可以及时获知病毒感染情况,以免造成院内感染。     

新型冠状病毒肺炎疑似患者鼻咽拭子标本采集环节的管理实践

鼻咽拭子行核酸检测是确诊新型冠状病毒肺炎的主要手段之一。本文主要介绍了环节管理在新型冠状病毒肺炎疑似患者鼻咽拭子标本采集中的实践经验,包括护士抗压能力培训、穿脱防护环节管理、鼻咽拭子标本采集流程管理、质量考核等,通过加强环节管理质量,保障医务人员工作安全,稳步提升护理服质量。     

淮南市新型冠状病毒感染病例实验室核酸检测结果分析

目的分析淮南市336例新型冠状病毒疑似病例核酸检测结果,为控制淮南市新型冠状病毒肺炎提供实验室诊断依据。方法根据国家卫生健康委办公厅《新型冠状病毒防控方案(第四版)》及《新型冠状病毒防控方案(第五版)》要求,通过对淮南市336例新型冠状病毒疑似病例同时采集咽拭子和痰液标本进行实验室核酸检测,并对核酸检测结果按年龄、性别分布、发病时间与检测阳性率关系及标本类型检测进行分析。结果淮南市从发现到零确诊(2020年1月24日～2020年2月19日)共检测新型冠状病毒疑似病例336人,核酸检测阳性病例总数为27例,阳性率8.04%(咽拭子或痰液标本中有任何一个核酸检测结果阳性即判定该病例为阳性);27例阳性病例中有19例为家庭聚集性病例;阳性病例中最小年龄15岁,最大年龄78岁,年龄中位数为40岁;阳性病例中男性15例(55.56%)、女性12例(44.44%),男女比例为1.25∶1;核酸检测阳性病例数主要集中在发病1～14天,核酸检测阳性平均发病时间为5天;痰液标本核酸检测阳性率大于咽拭子标本核酸检测阳性率;痰液标本核酸检测Ct值普遍低于咽拭子标本核酸检测的Ct值;27例阳性病例中病情发展为普通型26例,重型1例;截至3月2日,27例病例中已出院病例23例,剩余4例病情基本稳定。结论通过对淮南市336例新型冠状病毒核酸检测结果分析,有利于对新型冠状病毒肺炎病例进行早期诊断;在新型冠状病毒肺炎实验室诊断病例及出院病人实验室诊断时不能仅以咽拭子标本核酸检测阴性作为排除感染及治愈标准,而需同时检测病人咽拭子和痰液标本进行综合判断;加强个人卫生管理及人员密集的密闭公共场所的环境消毒工作,更有利于新型冠状病毒肺炎疫情防控。     

新型冠状病毒肺炎患者多类型样本SARS-CoV-2 核酸检测在临床诊疗中的意义

目的　探讨不同类型样本新冠核酸检测结果在新型冠状病毒肺炎（COVID-19）临床诊治和疫情防控中的意义。 方法　选取 2020 年1 月23 日~2 月22 日延安大学附属医院确诊的5 例COVID-19 患者,采集不同部位标本进行核酸 检测,并进行统计学分析。结果　采集的123 例标本严重急性呼吸综合征冠状病毒2（SARS-CoV-2）核酸检测结果表明, 咽拭子25 例,阳性率44.0％（11/25）; 鼻拭子40 例,阳性率25.0％（10/40); 肛拭子40 例, 阳性率70.0％（28/40);18 例血标本核酸检测均阴性,5 例患者符合出院标准时粪便核酸检测均阳性。截止3 月5 日对5 例患者出院后追踪发现, 出院2 周或更长时间粪便 SARS-CoV-2 核酸仍阳性。结论　多样本新冠核酸检测对于新冠感染患者的确诊有重要价值; 患者治愈出院后应加强随访、教育和复查,做好排泄物的管理,有利于巩固疫情防控效果,减少接触感染的发生。     

新型冠状病毒肺炎的实验室分子诊断及生物安全

该文就新型冠状病毒肺炎的病原体核酸检测及生物安全等方面进行了概述,包括病例定义、检测适应证、标本类型和标本采集、标本包装和运输、标本处理和核酸提取、病毒分子检测和结果判读,以及实验室生物安全,旨在提升临床实验室的检测质量,保障生物安全。     

2例新型冠状病毒肺炎粪便SARS-CoV-2核酸阳性临床启示

目前中国新型冠状病毒肺炎(COVID-19)疫情仍十分严峻,及时、早期地识别COVID-19患者是控制疫情的关键步骤。而新型冠状病毒(SARS-CoV-2)核酸检测作为诊断COVID-19的金标准,不但对检测技术提出更高的要求,同时对不同病程患者如何选择标本类型也是一个挑战。本文报道2例COVID-19确诊病例的诊疗经过,并分析采用不同类型标本检测SARS-CoV-2核酸的检出情况,为临床诊断COVID-19时如何选择标本类型和如何提高核酸检出率提供参考。     

Prevention program for the COVID-19 in a children’s digestive endoscopy center

The pneumonia caused by the coronavirus disease-2019(COVID-19)outbreak in Wuhan,China constitutes a public health emergency of international concern.The gastrointestinal symptoms of vomiting,diarrhea and abdominal pain and the detection of COVID-19 nucleic acid from fecal specimens in a small number of patients suggest the possibility of transmission via the gastrointestinal tract.People of all ages are vulnerable to this virus,including children.Digestive endoscopy is an invasive procedure during which children cannot wear masks;therefore,they have higher risks of exposure to COVID-19,and the digestive endoscopy center is a relatively high-risk area for COVID-19 infection.Based on these factors and in combination with related policies and regulations,a prevention and control program for the COVID-19 pneumonia in a children's digestive endoscopy center was established to prevent the COVID-19 nosocomial infection.     

Accuracy and Acceptance of a Self-Collection Model for Respiratory Tract Infection Diagnostics: A Concise Clinical Literature Review

BackgroundNurses are the primary clinicians who collect specimens for respiratory tract infection testing. The specimen collection procedure is time and resource-consuming, but more importantly, it places nurses at risk for potential infection. The practice of allowing patients to self-collect their diagnostic specimens may provide an alternative testing model for the current COVID-19 outbreaks. The objective of this paper was to evaluate the accuracy and patient perception of self-collected specimens for respiratory tract infection diagnostics.MethodsA concise clinical review of the recently published literature was conducted.ResultsA total of 11 articles were included the review synthesis. The concept of self-collected specimens has a high patient acceptance rate of 83-99%. Self-collected nasal-swab specimens demonstrated strong diagnostic fidelity for respiratory tract infections with a sensitivity between 80-100%, this is higher than the 76% sensitivity observed with self-collected throat specimens. In a comparative study evaluating a professionally collected to a self-collected specimen for COVID-19 testing, a high degree of agreement (k = 0.89) was observed between the two methods.ConclusionAs we continue to explore for testing models to combat the COVID-19 pandemic, self-collected specimens is a practical alternative to nurse specimen collection.     

Data monitoring committees for clinical trials evaluating treatments of COVID-19

The first cases of coronavirus disease 2019 (COVID-19) were reported in December 2019 and the outbreak of SARS-CoV-2 was declared a pandemic in March 2020 by the World Health Organization. This sparked a plethora of investigations into diagnostics and vaccination for SARS-CoV-2, as well as treatments for COVID-19. Since COVID-19 is a severe disease associated with a high mortality, clinical trials in this disease should be monitored by a data monitoring committee (DMC), also known as data safety monitoring board (DSMB). DMCs in this indication face a number of challenges including fast recruitment requiring an unusually high frequency of safety reviews, more frequent use of complex designs and virtually no prior experience with the disease. In this paper, we provide a perspective on the work of DMCs for clinical trials of treatments for COVID-19. More specifically, we discuss organizational aspects of setting up and running DMCs for COVID-19 trials, in particular for trials with more complex designs such as platform trials or adaptive designs. Furthermore, statistical aspects of monitoring clinical trials of treatments for COVID-19 are considered. Some recommendations are made regarding the presentation of the data, stopping rules for safety monitoring and the use of external data. The proposed stopping boundaries are assessed in a simulation study motivated by clinical trials in COVID-19.     

赣南地区护士新冠肺炎知信行现况及影响因素分析

目的 调查赣南地区临床护士对新型冠状病毒肺炎的知识、态度及行为水平的现状,并探讨其影响因素。方法 采用自行设计的新型冠状病毒肺炎知信行问卷对赣南地区二级以上医院的395名临床护士进行调查,并采用多元线性回归模型分析影响临床护士新冠肺炎知信行的因素。结果 共收回有效问卷395份,赣南地区临床护士新型冠状病毒肺炎相关知识、信念、行为及问卷总分的平均得分分别为41.17±8.04分、40.82±3.46分、45.07±3.81分、127.07±10.55分。多元线性分析发现职称、科室、是否有发热门诊工作经历与是否有隔离病区工作经历是新冠肺炎知识的影响因素,知识得分会影响临床护士对新冠肺炎的态度,态度得分会影响临床护士对新冠肺炎的行为。结论 临床护士新冠肺炎的知识有待进一步提升,但临床护士对新冠肺炎在工作及生活中的态度和行为较为积极,应加强新冠肺炎的培训和学术交流,重点关注低年资护士和未相关经历的临床护士新冠肺炎知识培训,护理管理者应创新护理管理及培训方式,根据不同护士的学习能力开展多样化的培训方式,以达到更好的培训效果。     

Use of convalescent plasma in COVID-19 patients with immunosuppression

In the absence of effective countermeasures, human convalescent plasma has been widely used to treat severe acute respiratory syndrome coronavirus 2, the causative agent of novel coronavirus disease 19 (COVID-19), including among patients with innate or acquired immunosuppression. However, the association between COVID-19-associated mortality in patients with immunosuppression and therapeutic use of convalescent plasma is unknown. We review 75 reports, including one large matched-control registry study of 143 COVID-19 patients with hematological malignancies, and 51 case reports and 23 case series representing 238 COVID-19 patients with immunosuppression. We review clinical features and treatment protocols of COVID-19 patients with immunosuppression after treatment with human convalescent plasma. We also discuss the time course and clinical features of recovery. The available data from case reports and case series provide evidence suggesting a mortality benefit and rapid clinical improvement in patients with several forms of immunosuppression following COVID-19 convalescent plasma transfusion. The utility of convalescent plasma or other forms of antibody therapy in immune-deficient and immune-suppressed patients with COVID-19 warrants further investigation.     

COVID-19 is a Real Headache!

After the emergence of a novel coronavirus named SARS-CoV-2, coronavirus disease 2019 (COVID-19) was initially characterized by fever, sore throat, cough, and dyspnea, mainly manifestations of respiratory system. However, other manifestations such as headache, abdominal pain, diarrhea, loss of taste and smell were added to the clinical spectrum, during the course of the COVID-19 pandemic. The reports on the neurological findings are increasing rapidly and headache seems to be the leader on the symptom list. Headache was reported in 11%-34% of the hospitalized COVID-19 patients, but clinical features of these headaches were totally missing in available publications. According to our initial experience, significant features of headache presentation in the symptomatic COVID-19 patients were new-onset, moderate-severe, bilateral headache with pulsating or pressing quality in the temporoparietal, forehead or periorbital region. The most striking features of the headache were sudden to gradual onset and poor response to common analgesics, or high relapse rate, that was limited to the active phase of the COVID-19. Symptomatic COVID-19 patients, around 6%-10%, also reported headache as a presenting symptom. The possible pathophysiological mechanisms of headache include activation of peripheral trigeminal nerve endings by the SARS-CoV-2 directly or through the vasculopathy and/or increased circulating pro-inflammatory cytokines and hypoxia. We concluded that as a common non-respiratory symptom of COVID-19, headache should not be overlooked, and its characteristics should be recorded with scrutiny.     

Convalescent plasma as a treatment modality for coronavirus disease 2019 in Sudan

Coronavirus disease 2019 (COVID-19) is a disease spreading rapidly in Sudan, the rest of the African continent and the world with no known definitive treatment or vaccines. However, among many treatment interventions being tested globally, beneficial effects and clinical improvements have been reported when convalescent plasma is used for treating COVID-19 patients. We prepared a guiding protocol for treating early to moderate COVID-19 patients with plasma transfusion from convalescent COVID-19 patients. This protocol was deduced based on previously published reports and studies that evaluated and tested convalescent plasma as a prospective therapy for COVID-19 patients. The protocol covers instructions on patient and donor selection criteria, plasma harvesting, plasma product specifications, dosage and precautions for convalescent plasma collection and transfusion process. Altogether, we prepared a treatment protocol that is tailored to the context of Sudan to be adopted by Sudan's health authority. Moreover, it will also provide reference for researchers to design open label clinical trials for convalescent plasma transfusion.