抗原|天津九安医疗电子股份有限公司 关于子公司收到iHealth新冠抗原家用自测OTC试剂盒 针对Omicron变异病毒测试性能实验报告的公告( 二 )
The FDA continues to authorize the use of these tests as directed in the authorized labeling and individuals should continue to use them in accordance with the instructions included with the tests. Antigen tests are generally less sensitive and less likely to pick up very early infections compared to molecular tests. In following the FDA's long-standing rapid test recommendations, if a person tests negative with an antigen test but is suspected of having COVID-19, such as experiencing symptoms or have a high likelihood of infection due to exposure, follow-up molecular testing is important for determining a COVID-19 infection. If a person tests positive with an antigen test, they should self-isolate and seek follow-up care with a health care provider to determine the next steps.
FDA官方网站就上述内容的发表链接如下:
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-
cov-2-viral-mutations-impact-covid-19-tests#omicronvariantimpact
特此公告 。
天津九安医疗电子股份有限公司
董事会
2022年1月7日
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