New Rutgers Saliva Test for Coronavirus Gets FDA Approval The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus, the first such approval granted by the federal agency. The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs (ADL), will allow for broader population screening than the current method of nose and throat swabs. “The impact of this approval is significant,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR, who also is a professor in the School of Arts and Sciences Department of Genetics at Rutgers University–New Brunswick. “It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections. We can preserve precious personal protective equipment for use in patient care instead of testing. We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections. All of this combined will have a tremendous impact on testing in New Jersey and across the United States.” Soon after the Rutgers-ADL team received notification from the FDA on Saturday, the White House’s COVID-19 testing task force called Brooks to offer congratulations and support and to ask about any specific hurdles to expanding testing and enabling other laboratories to benefit from the accomplishment. Shortly after the White House call, the research team was contacted by chief executive officers of some of the world’s largest life sciences companies that are involved in COVID-19 testing. “I have spoken with these companies’ leadership to not only share knowledge but to create opportunities for continuing to help innovate during this crisis,” Brooks said. “We will work closely with these new partners, the FDA and the White House task force to leverage everything Rutgers has to offer to not only help our community but also make a global impact.” Rutgers University President Robert Barchi called the new saliva test a “herculean effort that is great for the country and the world and by reflection great for our university.” “Saliva testing will help with the global shortage of swabs for sampling and increase testing of patients, and it will not require health care professionals to be put at risk to collect samples,” Brooks said. “Saliva testing will also be important for people who are in quarantine because they don’t know how long it will be until they are no longer infectious. This will allow health care workers to release themselves from quarantine and safely come back to work.” “The test can help hospital-based and private physicians to accurately assess the infection status of more patients, with RUCDR Infinite Biologics doing the analysis,” said Jay A. Tischfield, the founder, chief executive officer and scientific director of RUCDR and a Distinguished Professor also in the Department of Genetics at Rutgers–New Brunswick and at Rutgers Robert Wood Johnson Medical School. “Rutgers is proud to be on the cutting edge of the fight against the COVID-19 pandemic,” said Rutgers Biomedical and Health Sciences Chancellor Brian Strom. “We have long said our researchers and health care employees are working to help make the world well, but never has it been more true than now.” Rutgers University–New Brunswick Chancellor Chris Molloy agrees. “Rutgers has always been on the leading edge of research and discovery. We are proud of the work we do and the positive impact it has on the world.” The FDA’s approval of the new saliva testing approach is the second major announcement in recent days from RUCDR, which launched a genetic testing service for the coronavirus that can test thousands of samples daily. With the new saliva test, that number may increase to tens of thousands of samples daily. The tests are available to the RWJBarnabas Health network, which has partnered with Rutgers University and is New Jersey’s most comprehensive health care system, including Robert Wood Johnson University Hospital, University Hospital in Newark and many other facilities, including several county health departments. Starting Wednesday, Rutgers, in partnership with the Middlesex County government and RWJBarnabas Health, will make the test available to county residents at a drive-thru testing facility at 33 Kilmer Road, Edison, New Jersey.
The 100% accuracy title is 100% WRONG. The text mentioned that saliva samples are 100% in AGREEMENT with swaps. That does not mean the test is 100% accurate, it only means the test results from saliva samples are the same with the ones from swabs, the swabs may not be correct. Not to mention sample size is 60... I have yet to know any screening test that has a 100% accuracy. Still good news though, saliva samples are much easier than nasal swabs and will make the test much more accessible to the general public.
洛城24小时 2020/04/13 17:31 pm
收藏
分享
【洛杉矶华人资讯网编辑LEO LU编译】 美西时间4月13日，据美联社报道，罗格斯大学(Rutgers University)的研究人员已获得美国政府批准，进行首次唾液测试，以帮助诊断COVID-19新冠病毒。这种新方法，有助于扩大测试选项，并降低医护人员感染的风险。
有了这种新的基于唾液的测试，病人将得到一个塑料试管，他们可以向里面吐几次唾沫，然后将试管交还给医护人员进行实验室处理。 “这避免了医护人员不得不面对一个有症状的人，” 罗格斯大学实验室开发这项测试的负责人安德鲁布鲁克斯(Andrew Brooks)说。 一名没有参与这项测试的传染病专家说，这将有助于减轻测试者的一些不适，并降低提取样本时遇到的困难。 约翰霍普金斯大学（Johns Hopkins University）的阿达尔贾（Amesh Adalja）博士说:“我们希望可以在各种情况下都有很多种选择，这样我们就可以以最合适的方式进行尽可能多的测试。”阿达尔贾指出，类似的唾液测试还有助于扩大艾滋病毒和其他疾病的检测范围。 罗格斯通过采集60名患者的唾液和拭子样本来测试该方法的准确性，病人唾液样本的检测结果与拭子的结果100%吻合。 罗格斯利用来自美国犹他州Spectrum Solutions公司的唾液收集工具，开发出了这种实验室测试方法。Spectrum Solutions公司为基于DNA的血统测试服务提供类似的设备。布鲁克斯说，罗格斯大学的实验室目前每天可以处理1万个病人样本。 FDA在给罗格斯大学的授权信中说，这项测试应该只在“经过培训的医疗工作者监督下的医疗机构”进行。目前一些公司已经宣布将开始进行家庭测试的计划，但FDA还没有批准COVID-19在家庭中进行测试。 此外，FDA表示，使用唾液试剂盒检测结果呈阴性的患者应该用第二种检测方法来确认他们的结果。
相当于验孕纸和OB确诊怀孕的关系。
验孕纸可以确保90%以上的准确性，但是考虑到验孕纸过期，还有假阳性等问题，最后还是要OB确诊的。
专测阳性，阳的就错不了了
应该讲是测抗体或者病毒， 如果抗体或者病毒浓度不够就测不到。
不是阳的测不了，是告诉你，你已经有很严重的传染性了。
阳性的就确诊了，不用再用鼻咽取样了呀。阴性的再测，就初筛过一遍了
新冠不是有人有味觉丧失吗？说明病毒有侵入口腔在那里繁殖吧
https://news.google.com/articles/CBMic2h0dHBzOi8vcGhpbGFkZWxwaGlhLmNic2xvY2FsLmNvbS92aWRlby80NTEyMTQ1LXJ1dGdlcnMtdW5pdmVyc2l0eXMtbmV3LXNhbGl2YS10ZXN0LWZvci1jb3ZpZC0xOS1nZXRzLWZkYS1hcHByb3ZhbC_SAXdodHRwczovL3BoaWxhZGVscGhpYS5jYnNsb2NhbC5jb20vdmlkZW8vNDUxMjE0NS1ydXRnZXJzLXVuaXZlcnNpdHlzLW5ldy1zYWxpdmEtdGVzdC1mb3ItY292aWQtMTktZ2V0cy1mZGEtYXBwcm92YWwvYW1wLw?hl=en-US&gl=US&ceid=US%3Aen
是真的！
阳性测出就删去最恐怖的一类，逐次渐进法本来就是科学与数学的一个基本方法。
他们是在原有的Ebola 之类的工作上发展出的，不是突变。
呵呵呵恭喜恭喜
当年申请faculty，贵校不要我
病毒不在口腔繁殖。
上呼吸的病毒是下呼吸道漫上去的。
上呼吸道能检出，说明下面已经水漫金山了。
同不理解. 那准确率达100%是怎么来的? 而且哪儿有测试是100%的?
不是说近距离说话,溅到一点口水就传染吗? 还没有症状的时候也会传染. 那说明口水里肯定有,而且不少吧.
我其实更想要个敏感性很高的测试. 只要是阴性就是绝对没有. 如果是阳性就需要再去测一次.
好消息，赞一个
不对。最新研究是新冠病毒一开始能在上呼吸道繁殖，所以病情初期无症状就可以感染别人，和SARS完全不同。据分析和新冠有Furin蛋白酶切割点有关系，导致ACE2表述少的上呼吸道能被感染。
所以唾沫能测新冠是意料中的事，主要是精度问题。鼻涕样本估计应该更适合一些。
不懂了，病毒不是从口鼻眼进入体内的吗？难道不是自上而下的吗？
这个是真的，昨天看了英文报道，周三开始,一天可以测1万个
这个是真的，昨天看了英文报道，周三开始,一天可以测1万个
有人不是每个人，失去味觉只是非常少一部分人。
我们市的医院已经用上15分钟的那个测试方法了，加上护士取样，送lab 到取结果，差不多30-45分钟就能确诊了。
唉？我去找找paper。
意思就是不比现在的其他测试方法效果差
写中文题目的人是SB