'Home testing kit' for new coronavirus infection finally approved by US government
The U.S. Food and Drug Administration (FDA), which oversees regulation and management of pharmaceuticals in the United States, approved a test kit developed by LabCorp, a major clinical laboratory, that can perform PCR test of new coronavirus infection (COVID-19) at home. did. This is the first time the FDA has approved a new coronavirus test kit.
COVID-19 | Pixel by LabCorp
Coronavirus (COVID-19) Update: FDA Authorizes First Test for Patient At-Home Sample Collection | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection
LabCorp COVID-19 Self-collection Test Kit Receives FDA Emergency Use Authorization | LabCorp
https://www.labcorp.com/coronavirus-disease-covid-19/labcorp-newsroom/labcorp-covid-19-self-collection-test-kit-receives-fda-emergency-use-authorization
The COVID-19 home-based test kit manufactured by LabCorp in the United States, which operates the world's largest clinical test network, allows users to post samples of their own nose taken with a cotton swab to their research facility. The test results can be confirmed from the company's website, and the user can complete the test from home completely.
Regarding approval, the FDA has confirmed that 'Sample collection using the test kit in question is as safe and accurate as sample collection performed in clinics, hospitals, etc.' We have increased the number of convenient and reliable choices for taking samples comfortably and safely at home. '
LabCorp will make the test kit available to consumers in almost every state in the United States over the next few weeks, but for the time being, healthcare workers will be given priority. A PCR test using this test kit costs $ 119 (about 13,000 yen) each time, and the company needs to answer a simple questionnaire test to acknowledge the necessity of the test in order to purchase the test kit I am.
Also, this approval is only for PCR tests using a home test kit developed by LabCorp, not a sample collection kit using a cotton swab or something else, or an approval for PCR test at home FDA says I am emphasizing. The FDA also cautions against taking samples with cotton swabs other than those included in the LabCorp-developed home test kit, because the genetic material contained in the cotton swabs can affect the test results.
LabCorp said the company's home test kit has been approved by the FDA. `` Our developed COVID-19 home test kit was tested for health care workers and emergency responders who show COVID-19 symptoms. As part of our ongoing commitment to providing the highest availability and availability of the test, allowing individuals to collect samples at home, preventing the risk of spreading the infection to others, masks, gloves, and We can reduce the consumption of
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