在美国美国食品药品监督管理局批准了另外两项易于购买和执行的在家测试后，更多的美国人将很快能够在当地药店或零售店购买无需处方的非处方快速冠状病毒测试。
美国食品和药物管理局周四授权美国新冠肺炎检测制造公司雅培公司进行新冠肺炎抗原自我检测。它还授权诊断保健品制造商魁地尔进行快速Vue测试。
两者都不需要处方。
雅培表示，其新冠肺炎抗原自检将适用于有症状或无症状的个人。
雅培公司总裁兼首席执行官罗伯特·福特说:“与疫苗一起，BinaxNOW自检将帮助美国人更有信心地回到他们想做和需要做的事情上，比如去上班、上学或看望朋友和家人。”
雅培的快速检测最初需要医疗保健提供商管理拭子和基于溶液的检测试剂盒，然后授权在家使用，由虚拟监督者观察过程，这包括在25美元的费用中。这一新的美国食品和药物管理局授权允许个人自己进行测试，无需医生处方，成本更低。
雅培发言人告诉美国广播公司新闻，这些测试预计将分两次出售，每次测试的费用不到10美元。这位发言人还表示，测试将在未来几周内进行。
根据该公司的说法，用户只需要进行微创的鼻拭子检查，而不是一些聚合酶链反应测试中常见的更深的鼻交换，并且可以在大约15分钟内得到结果。
Quidel的测试是为14岁或14岁以上的人自行收集的鼻拭子和成人收集的2岁及以上儿童标本而设计的。
与分子聚合酶链反应检测相比，快速抗原检测具有成本更低、供应更少、速度更快的优势，后者需要一到两天的实验室处理时间。聚合酶链反应检测可以检测到较低水平的复制病毒，但抗原检测旨在准确检测出一个人何时患病并最有可能传染的病毒。
食品和药物管理局已经讨论了这些限制一些快速抗原检测的准确性，并注意到它们可能会出现假阳性结果——尤其是在特定群体中没有大量活跃病毒或检测不正确的情况下。快速抗原检测的支持者指出，更多的人能够识别何时最具传染性，这样他们就知道立即隔离而不是传播病毒。仍然鼓励确认测试。
雅培公司的首席科学家玛丽·罗杰斯说:“这项测试的准确率超过95%，这是我们需要有信心回到我们喜欢做的所有事情上的水平。”"我们的生产部门准备每月提供几千万次测试."
泰德·沃伦/美联社档案
华盛顿州塔科马市的雅培实验室进行的比纳克索快速新冠肺炎测试。，2021年2月3日。
魁地奇，在一份新闻稿中该公司表示，其测试“在83.5%的阳性时间和99.2%的阴性时间提供与聚合酶链反应一致的结果”该公司没有说明发布测试的时间表。
新测试的涌入正值美国面临新冠肺炎测试日常管理的下降趋势，卫生保健工作者现在专注于分发疫苗注射。据英国《每日邮报》报道，全国新冠肺炎每日检测率刚刚超过100万约翰·霍普金斯冠状病毒资源中心。
公共卫生专家认为，随着新冠肺炎每天的病例量攀升，低检测数字并不是国家完全摆脱大流行的必要条件。
哥伦比亚大学邮差公共卫生学院流行病学和医学教授瓦法阿·埃尔·萨德尔博士说:“进行测试的人往往是接种疫苗的人。”“对一些供应问题的关注可能会影响对疫苗而非测试的关注。”
现在只有大约17%的美国人完全接种了疫苗，冠状病毒检测仍然是跟踪新病例和阻止传播的重要工具。
美国食品和药物管理局在3月份发布了额外的指南，为寻求紧急使用授权的测试开发商提供筛查大规模人群新冠肺炎感染的测试。这是一个指南，对于寻求保护免受冠状病毒感染的雇主和学校管理人员来说可能会派上用场。
“有了美国食品和药物管理局对多项测试的授权，公众可以放心，这些测试已经达到了我们紧急使用授权的科学标准，”美国食品和药物管理局设备和放射健康中心主任杰夫·庶人博士说。“就像我们一直说的那样，如果这是一个好的测试，我们会批准的。”
FDA authorizes rapid, non-prescription COVID-19 tests
More Americans will soon be able to purchase over-the-counter rapid coronavirus tests without a prescription at their local pharmacy or retail store following the U.S. Food and Drug Administration’s authorization of two more at-home tests that are easy to buy and perform.
The FDA on Thursday authorized BinaxNOW, a COVID-19 antigen self-test by Abbott, a U.S. COVID-19 testing manufacturing company. It also authorized the Quick Vue test by Quidel, a diagnostic health care product manufacturer.
Neither requires a prescription.
Abbott says its COVID-19 antigen self-test will be available to individuals with or without symptoms.
"Together with vaccines, the BinaxNOW self-test will help Americans get back to doing what they want and need to do -- like going to work and school or seeing friends and family -- with greater confidence," said Robert Ford, Abbott’s president and chief executive officer.
Abbott’s rapid test initially required a health care provider to administer the swab and solution-based test kit, and then it was authorized for at-home use with a virtual proctor watching the process, which was included with the $25 fee. This new FDA authorization allows an individual to perform the test themselves, without a doctor’s prescription and at a lower cost.
An Abbott spokesperson told ABC News the tests are expected to be sold in packs of two and will cost under $10 dollars per test. The spokesperson also said the test should be available in the coming weeks.
Users will only need to perform a minimally invasive nasal swab, not the deeper nasal swaps common in some PCR tests and can expect results in about 15 minutes, accordiing to the company.
Quidel's test is designed for self-collected nasal swabs for people 14 or older and for adult-collected specimens of children 2 years and up.
Rapid antigen tests provide the advantage of lower costs, fewer supplies and speed than molecular PCR tests, which take one to two days for laboratory processing. PCR tests can detect lower levels of replicating virus, but antigen tests are intended to be accurate at detecting virus when a person is actively sick and most likely contagious.
The FDA has discussed the limitationsof the accuracy of some rapid antigen tests and noted that they may be subject to false positive results – especially if there is not a lot of active virus in a specific community or if they are performed incorrectly. Proponents of rapid antigen tests point out the benefit of more people being able to identify when they are most contagious so they know to immediately isolate and not pass on the virus. Confirmation testing is still encouraged.
"The test performs at greater than 95% accuracy, and that’s the kind of level that we need to have the confidence to return to all the many things that we love to do," said Mary Rodgers, principal scientist at Abbott. "We are prepared with our manufacturing to supply tens of million tests a month."
Quidel, in a press releasesaid its test "provides results in agreement with PCR 83.5% of the time when positive and 99.2% when negative." The company did not indicate a timeline for the release of its tests.
The influx of new tests comes as the nation faces a downward trend in the daily administration of COVID-19 tests, with health care workers now focused on distributing vaccine shots. The daily national COVID-19 testing rate is just over 1 million a day, according tothe Johns Hopkins Coronavirus Resource Center.
Public health experts argue that the low testing numbers are not where the nation needs to be to fully pull itself out of the pandemic, as the daily COVID-19 caseload creeps upward.
"The same people who are doing the testing are often the same ones doing the vaccinations," said Dr. Wafaa El-Sadr, professor of epidemiology and medicine at Columbia University Mailman School of Public Health. "And the attention to some of the issues around supply may affect the focus turning to vaccines rather than tests."
With just about 17% of Americans now fully vaccinated, coronavirus testing remains an important tool in tracking new cases and putting a halt to spread.
The FDA in March issued additional guidance for test developers seeking emergency use authorization of tests screening large groups of individuals for COVID-19 infections. It is guidance that could come in handy for employers and school administrators looking for protection from bouts of coronavirus infection.
"With the FDA’s authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization," said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. "As we’ve said all along, if it’s a good test, we’ll authorize it."
