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2019冠状病毒病检测:修订间差异

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*[http://news.rapidmicromethods.com/2020/03/abbott-launches-5-minute-covid-19.html Abbott Launches 5-Minute COVID-19 Isothermal Point-of-Care Test]
*[http://news.rapidmicromethods.com/2020/03/abbott-launches-5-minute-covid-19.html Abbott Launches 5-Minute COVID-19 Isothermal Point-of-Care Test]
*[https://www.medsci.cn/article/show_article.do?id=01c8191028af 5分钟!FDA紧急使用授权批准雅培COVID-19即时检测!]</ref>,而有报道称目前雅培病毒检测设备的结果准确度不尽令人满意<ref>{{cite news|url=https://www.wsj.com/articles/coronavirus-testing-hampered-by-disarray-shortages-backlogs-11587328441?mod=hp_lead_pos5 |title=Coronavirus Testing Hampered by Disarray, Shortages, Backlogs |website=Wall Street Journal |date=2020-04-19}}</ref><ref>{{cite news|url=https://k.sina.com.cn/article_2780297340_va5b7f87c01900q3pn.html?from=health|title=5分钟出新冠检测结果…美国这个“黑科技”靠谱吗? |website=新浪网 |date=2020-04-24}}</ref><ref>[https://www.biorxiv.org/content/10.1101/2020.05.11.089896v1 Performance of the rapid Nucleic Acid Amplification by Abbott ID NOW COVID-19 in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution]</ref><ref>[https://www.bloomberg.com/news/articles/2020-05-13/false-negatives-raise-more-questions-about-virus-test-accuracy?sref=IjU66rxU Prognosis: False Negatives Raise More Questions About Virus Test Accuracy]</ref><ref>[https://www.npr.org/sections/coronavirus-live-updates/2020/05/14/856531970/fda-cautions-about-accuracy-of-widely-used-abbott-coronavirus-test FDA Cautions About Accuracy Of Widely Used Abbott Coronavirus Test]</ref>。
*[https://www.medsci.cn/article/show_article.do?id=01c8191028af 5分钟!FDA紧急使用授权批准雅培COVID-19即时检测!]</ref>,而有报道称目前雅培病毒检测设备的结果准确度不尽令人满意<ref>{{cite news|url=https://www.wsj.com/articles/coronavirus-testing-hampered-by-disarray-shortages-backlogs-11587328441?mod=hp_lead_pos5 |title=Coronavirus Testing Hampered by Disarray, Shortages, Backlogs |website=Wall Street Journal |date=2020-04-19}}</ref><ref>{{cite news|url=https://k.sina.com.cn/article_2780297340_va5b7f87c01900q3pn.html?from=health|title=5分钟出新冠检测结果…美国这个“黑科技”靠谱吗? |website=新浪网 |date=2020-04-24}}</ref><ref>[https://www.biorxiv.org/content/10.1101/2020.05.11.089896v1 Performance of the rapid Nucleic Acid Amplification by Abbott ID NOW COVID-19 in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution]</ref><ref>[https://www.bloomberg.com/news/articles/2020-05-13/false-negatives-raise-more-questions-about-virus-test-accuracy?sref=IjU66rxU Prognosis: False Negatives Raise More Questions About Virus Test Accuracy]</ref><ref>[https://www.npr.org/sections/coronavirus-live-updates/2020/05/14/856531970/fda-cautions-about-accuracy-of-widely-used-abbott-coronavirus-test FDA Cautions About Accuracy Of Widely Used Abbott Coronavirus Test]</ref>。
*{{link-en|快速抗原检测|Rapid antigen test}}:抗原检测最近应用于检测COVID-19病毒带来的特有的蛋白分子,有速度快的优点,但也有灵敏度方面的不足:[[假阴性]]检测结果的比例较高。<ref>[https://www.theverge.com/2020/5/9/21253105/fda-covid-19-antigen-test-coronavirus FDA authorizes rapid COVID 19 antigen test: The test is quicker than PCR tests but has a high rate of false negatives]</ref><ref name=cnn_test_types>{{cite web |url=https://www.cnn.com/2020/04/28/us/coronavirus-testing-pcr-antigen-antibody/index.html |title= What to know about the three main types of coronavirus tests |publisher=CNN |access-date=30 April 2020|date =29 April 2020 }}</ref> 快速检测结果为阴性的[[樣品 (物質)|样品]]可经由上面提到的核酸检测进一步确认。
*{{link-en|快速抗原检测|Rapid antigen test}}:抗原检测最近应用于检测COVID-19病毒带来的特有的蛋白分子,有速度快的优点,但也有灵敏度方面的不足:[[假阴性]]检测结果的比例较高。<ref>[https://www.theverge.com/2020/5/9/21253105/fda-covid-19-antigen-test-coronavirus FDA authorizes rapid COVID 19 antigen test: The test is quicker than PCR tests but has a high rate of false negatives]</ref><ref name=cnn_test_types>{{cite web |url=https://www.cnn.com/2020/04/28/us/coronavirus-testing-pcr-antigen-antibody/index.html |title= What to know about the three main types of coronavirus tests |publisher=CNN |access-date=30 April 2020|date =29 April 2020 }}</ref> 快速检测结果为阴性的[[樣品 (物質)|样品]]可经由上面提到的PCR核酸检测进一步确认。
*{{link-en|抗体检测|Serology#Serological_tests}}:基于[[血清学|血清]]抗体的[[免疫分析|免疫测定法]]通过人体对病毒入侵导致的[[免疫系统#适应性免疫|免疫反应]]间接检测COVID-19病史。因为产生抗体相对病毒感染有一段时间滞后,抗体检测对人体初期感染不敏感,准确度的一致性比较差;现有各种抗体检测产品[[假阳性]]结果经常出现<ref>{{cite web |url=https://www.cbsnews.com/news/coronavirus-antibody-testing-inaccurate-data-60-minutes-2020-06-28/ |title= Flawed COVID-19 antibody tests shipped without FDA review |publisher=CBS News |access-date=28 June 2020</ref> 相对优点是检测操作便捷、采样感染风险低,往往可以在一小时内获得结果,并比较适合于对群体疫情进行{{link-en|疫情监测|Public health surveillance|监测}}及接触者追踪等相关{{link-en|流行病学分析|Epidemiological method}}。<ref name="nature20200323"/><ref name="wired20200325">{{cite web|url=https://www.wired.com/story/researchers-push-for-mass-blood-tests-as-a-covid-19-strategy/|title=Researchers Push for Mass Blood Tests as a Covid-19 Strategy|website=www.wired.com}}</ref><ref name="bloomberg20200327"/><ref name="smithsonian20200407"/><ref name=cnn_test_types/>
*{{link-en|抗体检测|Serology#Serological_tests}}:基于[[血清学|血清]]抗体的[[免疫分析|免疫测定法]]通过人体对病毒入侵导致的[[免疫系统#适应性免疫|免疫反应]]间接检测COVID-19病史。因为产生抗体相对病毒感染有一段时间滞后,抗体检测对人体感染初期(一周内)不敏感,准确度的一致性比较差;<ref name="nih20200625">{{Cite journal|last=Deeks|first=Jonathan J.|last2=Dinnes|first2=Jacqueline|last3=Takwoingi|first3=Yemisi|last4=Davenport|first4=Clare|last5=Spijker|first5=René|last6=Taylor-Phillips|first6=Sian|last7=Adriano|first7=Ada|last8=Beese|first8=Sophie|last9=Dretzke|first9=Janine|last10=Ferrante di Ruffano|first10=Lavinia|last11=Harris|first11=Isobel M.|date=June 25, 2020|title=Antibody tests for identification of current and past infection with SARS-CoV-2|url=https://www.ncbi.nlm.nih.gov/pubmed/32584464|journal=The Cochrane Database of Systematic Reviews|volume=6|pages=CD013652|doi=10.1002/14651858.CD013652|issn=1469-493X|pmid=32584464|via=}}</ref> 现有各种抗体检测产品[[假阳性]]结果经常出现<ref>{{cite web |url=https://www.cbsnews.com/news/coronavirus-antibody-testing-inaccurate-data-60-minutes-2020-06-28/ |title= Flawed COVID-19 antibody tests shipped without FDA review |publisher=CBS News |access-date=28 June 2020</ref> 此类测试是否适用于检测[[亞臨床感染|亚临床]]或轻微感染导致的较低水平抗体,也有待进一步研究。<ref name="nih20200625"/> 相对优点是检测操作便捷、采样感染风险低,往往可以在一小时内获得结果,并比较适合于对群体疫情进行{{link-en|疫情监测|Public health surveillance|监测}}评估及接触者追踪等相关{{link-en|流行病学分析|Epidemiological method}}。<ref name="nature20200323"/><ref name="wired20200325">{{cite web|url=https://www.wired.com/story/researchers-push-for-mass-blood-tests-as-a-covid-19-strategy/|title=Researchers Push for Mass Blood Tests as a Covid-19 Strategy|website=www.wired.com}}</ref><ref name="bloomberg20200327"/><ref name="smithsonian20200407"/><ref name=cnn_test_types/><ref>{{cite web |url=https://www.statnews.com/2020/03/27/serological-tests-reveal-immune-coronavirus/ |title= The next frontier in coronavirus testing: Identifying the full scope of the pandemic, not just individual infections |publisher= STAT|access-date=30 April 2020|date = 27 March 2020}}</ref>


===SARS-CoV-2病毒检测的采样方法===
===SARS-CoV-2病毒检测的采样方法===

2020年7月11日 (六) 20:34的版本

2019冠状病毒病检测(英語:COVID-19 testing)是通過核酸抗体抗原分子检测英语Molecular diagnostics手段[1][2][3]及胸腔CT断层成像等临床辅助手段,对人体是否感染2019冠状病毒(SARS-CoV-2)或患有2019冠状病毒病(COVID-19)予以诊断。

2019冠状病毒病检测在2019冠状病毒病疫情中,对于及时诊断、救治患者[1][2][4][5][6][7]疫情监视、恢复经济[8][9][10][3],起着非常重要的作用。 韩国[11][12]与德国[13]在疫情早期开始的广泛而卓有组织的检测、隔离和接触者追踪措施,被认为是其得以较为成功控制冠状病毒疫情的背后原因。 由于病毒携带者可能的无症状感染以及目前尚未开发出可普遍应用的有效疫苗治疗方法英语COVID-19 drug development,充分而及时的COVID-19检测(及相关接触者追踪、感染者隔离疫情监视)是尽早解脱目前普遍的居家隔离英语Stay-at-home order出行限制英语COVID-19 pandemic lockdowns、从经济衰退状态下安全重启经济的关键。

COVID-19分子与血清检测

COVID-19分子与血清检测的三类方法

SARS-CoV-2病毒检测的采样方法

核酸检测及抗原检测的灵敏度很大程度上取决于正确的采集方法和时机。采样类型包括:上呼吸道标本、下呼吸道标本(痰液、气道抽取物、肺泡灌洗液)、血液、粪便、尿液和结膜分泌物等。[26] 对门诊患者或初期病毒检测,应优先采集上呼吸道样本(鼻腔、喉咙取样)[27][28] ;对较严重的呼吸道疾病患者优先采集下呼吸道样本(气管内抽吸或支气管肺泡灌洗)。[28]

鼻咽拭子

上呼吸道 採集樣本方法包括:

COVID-19确诊方法

分子检测确诊方法

图为美国疾控中心的SARS-CoV-2病毒检测盒

针对感染SARS-CoV-2的病例,需要实时荧光RT-PCR检测病毒核酸呈阳性才能完全确诊。但是在临床实践中,不排除测试结果呈虚假的反应的可能出现,应结合流行病学接触史和临床特点进行综合分析。[32]这些确诊手段不影响对患有相关症状的病患由医院进行标准的诊断和治疗,确诊为病毒携带者后再会被送至定点医院进行定向治疗。[32][33]對感染新型冠狀病毒的疑似病例進行確診必須採集相關樣本,实时荧光RT-PCR检测新型冠状病毒核酸阳性者可以确诊。在對呼吸道樣本或血液樣本進行病毒基因測序後,若與已知的新型冠狀病毒高度同源,即為確診病例。[34]若無法透過RT-PCR確診,則臨床上疑似病例須結合流行病學接觸史和影像學檢查结果等臨床特点綜合分析。[34]

RT-PCR

RT-PCR测试是现有的对SARS-CoV-2病毒进行检测的主流方式。[32][35]有研究从效率和成本上就这类方式提出其他替代方式,且指出在临床实践中RT-PCR测试针对SARS-CoV-2的劣势。[36][37]在COVID-19患者感染后期,医护人员采用RT-PCR测试复核症状消退的患者是否消除体内病毒。有研究发现有些患者依然存在弥漫性肺泡损伤,其中主要浸润的免疫细胞只有CD68+ 巨噬细胞、CD20+ B细胞以及CD8+ T细胞。[36]因此,尽管利用鼻拭子样本进行的测序显示为阴性,可在病患的肺部组织中发现残留的病毒存在。这一发现建议,针对患者应当更多使用支气管肺泡灌洗液为样本来做PCR,并对已出院的患者跟踪检查。[36]

针对RNA病毒,北京大学清华大学的研究者联合发表了一种新型确认病人感染新型冠状病毒的测序手段SHERRY。这种手段透過基于Tn5转座酶的转录组测序,相比传统的smart-seq2技术有更好的效率,减少了样本的需求量。新型冠状病毒是SHERRY首次在临床上进行应用的对象。[38]

2020年3月12日,瑞士制药罗氏公司宣布该公司基于核酸检测的商业化检测方法得到了美国食品和药物管理局(FDA)的紧急使用授权英语Emergency Use Authorization[39]。该测试可以在全自动设备上大量进行,极大地提高了检测效率。罗氏表示,利用该公司的cobas 6800&8000分子测试系统,可以在24小时之内检测分别检测1440,4128个样本。[40]

CRISPR

针对SARS-CoV-2常用的检测手段为RT-PCR。[41]有研究认为,现在主要的qRT-PCR检测耗时从获取样本到得出结果超过24小时,因此试图利用CRISPR技术在实践中提供更快的检测。[42]这一研究中开发的DETECTR检测技术基于Cas12蛋白,由于其试剂的便携性认为可以用于在实验室外的地方以提高效率。[42]

恒温扩增

影像学检测

对患者使用胸腔断层扫描检查,可观察到影像学异常。早期患者的肺部会呈现多发小斑片影及间质改变,以肺外带明显。经发展后,肺炎患者被观察到双肺多发毛玻璃狀病變英语Ground-glass opacity、浸润影。严重者则会进一步发展为次节叶或大叶性肺实变英语Pulmonary consolidation影像表现,胸腔积液少见[43]。有一部分的病人,可能在逆轉錄聚合酶鏈式反應測試(RT-PCR)陰性的情形下,在電腦斷層上卻出現早期典型的肺實變[44]

胸部電腦斷層

在胸部電腦斷層的檢查中,可能有三種較常見的表現,分別為:[45]

  • 雙側周邊為主的毛玻璃狀病變:約90%[45]
  • 肺部血管增厚(Vascular Thickening):約59%[45]
  • 網狀陰影變化(Fine Reticular Opacity):約56%[45]

以下三種表現在COVID-19較為少見表現,需考慮其他肺炎可能性:[45]

相关数据、条目及链接

各国检测相关数据

应用抗体检测与核酸检测对美国COVID-19患者数目的估计

美国疾病控制与预防中心官员依据抗体检测英语Serology#Serological_tests数据估计,美国正在或曾经罹患COVID-19患者可能达到两千万人,约十倍于经由核酸检测英语Nucleic acid test确诊的官方数字(230万至240万之间)。[46]

各国次级行政区检测数据

2020年4月,湖北省武昌实验中学组织高三学生免费开展核酸检测 迎接复课
次级行政区 检测数 时间
广东省 3600000 累计截至4月11日[47]
湖北省 89685 累计截至2月5日[48]
武汉市 5427937 5月14日至21日[49]


相关条目

外部链接

参考资料

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