关于有多好的问题快速新冠肺炎测试工作当涉及到检测omicron变体时，领先的科学家现在让公众放心，他们确实在工作，并在正在进行的疫情中发挥宝贵的作用。
其中包括美国国立卫生研究院国家生物医学成像和生物工程研究所所长、负责快速加速诊断的顶尖科学家布鲁斯·特罗姆伯格博士。RADx是一个新的由政府资助的NIH项目，其任务是快速提高国家的测试能力，并研究面对新变种时测试的表现。
特罗姆伯格说:“这些测试是我们需要的一个重要组成部分，尤其是在奥米克隆发展非常迅速的时候。
虽然聚合酶链反应检测在检测少量病毒的存在方面非常有效，但快速检测已经成为确定一个人是否具有传染性的一种快速简单的方法。在周二的一份声明中，食品药品监督管理局表示，快速测试确实检测到了奥米克龙变异体，但在实验室环境中，它们的表现不如早期变异体。
美国食品和药物管理局的声明被一位专家描述为一种曲线球，缺乏具体的数字，并在一些专家和美国人中引发了困惑和沮丧，他们一直在使用快速检测来降低节日期间新冠肺炎病毒传播给亲人的风险。
迈克尔·米娜博士是增加快速测试使用的积极倡导者，也是eMed的首席科学官，他告诉美国广播公司新闻，“没有理由也没有数据支持这些测试检测奥米克隆病毒的能力较低。”
美国食品和药物管理局关于快速检测检测奥米克龙能力的消息是在拜登政府宣布美国将拥有5亿个奥米克龙之后发布的在家快速测试从一月份开始提供。
但特罗姆伯格表示，美国人“绝对不应该”被劝阻使用基于美国食品和药物管理局这一声明的快速检测，该声明是基于对来自多个患者的活病毒样本的初步实验室研究，并在相对较少的快速检测品牌上运行。
南y .嗯/美联社
周四，人们在芝加哥一个免费的聚合酶链反应和快速检测站排队接受新冠肺炎检测...
他说，这些测试显示了有效性的潜在下降，但“这并不意味着它们从地图上消失了”。美国食品和药物管理局还表示，还需要更多的临床研究。
在实验室进行的初步研究可以提供更多的线索，但不如在真实人群中进行的真实研究可靠。特罗姆伯格说，这些真实世界的临床研究目前正在进行，结果应该很快就会出来。
他预计临床研究将显示测试工作在可接受的水平。
“我们已经知道，临床表现比这种实验室台式表现更好，只是在我们获得的早期研究中。”
特罗姆伯格说:“我有信心，我们货架上的测试可以让奥米克龙振作起来。“将会有不同的表现水平，我们需要真正完成所有这些，并在每次测试中理解它们。”
米娜说，快速测试可能表现不同的一个原因是因为新变种的传染性增加了。
“是检测不太敏感，还是病毒传染性更强?”他说。
米娜说:“奥米克隆的传染性更强，因此，人们有可能在检测呈阳性前几个小时或一天开始传播病毒，但在此之后，当人们传染性最强时，检测仍将有效，就像他们一直在整个疫情工作一样。”。
特罗姆伯格说，即使一些快速测试的表现被削弱，“它们在中断病毒传播链方面仍然非常强大和有效。”
美国食品和药物管理局已经批准了43项快速抗原测试，包括至少十几项家庭测试。
几家测试公司表示，他们的测试仍在检测奥米克龙，雅培周二表示，该公司已经使用来自活病毒的奥米克龙变体测试了流行的BinaxNOW快速测试，发现该测试与之前的变体相比“以同等的灵敏度进行”。
但美国食品和药物管理局表示，如果进一步的测试显示需要更新，测试可能会更新。
美国食品和药物管理局发言人斯蒂芬妮·卡科莫说:“研究正在进行中，以确认敏感性明显下降的原因。“一旦知道了这一点，如果合适的话，每个开发人员都可以在美国食品和药物管理局的支持下对现有的测试进行调整。”
Top COVID-19 test scientist says there's no reason to stop using rapid tests
With questions swirling about how wellrapid COVID-19 testswork when it comes to detecting the omicron variant, leading scientists are now reassuring the public that they do work, and have a valuable role to play in the ongoing pandemic.
Among them is Dr. Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering at the NIH, and the top scientist in charge of Rapid Acceleration of Diagnostics. RADx, a new government-funded NIH program, was tasked with rapidly increasing the nation's testing capacity and studying how tests perform when faced with new variants.
"The tests are an essential component of what we need, especially in the time of very rapidly expanding omicron," Tromberg said.
While PCR tests are very effective at detecting the presence of even small amounts of virus, rapid tests have become a quick and easy way to determine if a person is contagious. In a Tuesday announcement, the Food and Drug Administration said rapid tests do detect the omicron variant, but in a laboratory setting they did not perform as well as they have with earlier variants.
The FDA announcement, described by one expert as a kind of curveball, lacked specific numbers and sparked confusion and dismay among some experts and Americans who have been using rapid tests to reduce the risk of spreading COVID-19 to loved ones over the holidays.
Dr. Michael Mina, a vocal advocate for increased rapid testing use and the chief science officer for eMed, told ABC News, "There is no reason and no data to support that the tests are less able to detect omicron virus."
News from the FDA about rapid tests' ability to detect omicron comes on the heels of the Biden Administration's announcement that the U.S. will have 500 millionat-home rapid testsavailable starting January.
But Tromberg said Americans should "absolutely not" be discouraged from using rapid tests based on this FDA announcement, which was based on preliminary laboratory studies on live virus samples combined from multiple patients and run on a relatively small number of rapid test brands.
Those tests showed a potential dip in effectiveness, but, "It's not like they fell off the map," he said. The FDA also said more clinical studies are needed.
Preliminary studies conducted in a lab can offer clues, but are not as reliable as real-world studies done on real people. Those real-world clinical studies are currently being conducted, and results should be available shortly, Tromberg said.
He expects clinical studies to show the tests are working at an acceptable level.
"We already know that the clinical performance is better than this laboratory benchtop performance, just in our early studies that we're getting."
"I have confidence that the tests that we have on our shelves can pick up omicron," Tromberg said. "There will be different levels of performance, we need to really work through all of those and understand them for every test."
One reason rapid tests might perform differently is because of the increased infectiousness of the new variant, said Mina.
"Is it that the test is less sensitive, or is the virus more infectious?" he said.
"Omicron is more infectious, and therefore, it is possible that people can start spreading the virus hours or a day before they are testing positive, but after that, the test will still work when people are most infectious just as they have been working throughout the entirety of the pandemic," Mina said.
Even if some rapid test performance is diminished, Tromberg said, "They still can be extremely powerful and effective at interrupting the chain of transmission of the virus."
The FDA has authorized 43 rapid antigen tests including at least a dozen at home versions.
Several testing companies have said their tests still work to detect omicron, with Abbott saying Tuesday that the company has tested the popular BinaxNOW rapid test using the omicron variant from live virus and found the test "performed at equivalent sensitivity" compared to prior variants.
But the FDA said tests could be updated if further testing shows updates are needed.
"Studies are underway to confirm the reason for the apparent decreased sensitivity," FDA spokespersons Stephanie Caccomo said. "Once that is known, adjustments to existing tests can be undertaken by each developer with support from the FDA, if appropriate."
