U.S. FDA authorizes the first COVID-19 test to screen asymptomatic people
-
Last Update: 2020-07-29
-
Source: Internet
-
Author: User
Search more information of high quality chemicals, good prices and reliable suppliers, visit
www.echemi.com
Guide: This Emergency Use Authorization (EUA) is the LabCorp COVID-19 RT-PCR Test!----the FDA has urgently authorized the first COVID-19 diagnostic test for extensive screening, including testing for people who have shown no symptoms and have not been exposed to confirmed cases, and allowed to combine sample testsThis Emergency Use Authorization (EUA) was obtained by the LabCorpCOVID-19RT-PCR testOn March 16 this year, LabCorp's new coronavirus diagnostic test was first approved by the FDA, but only for prescriptions, to detect people who show signs of early viral infections, such as fever, as well as high-risk groups and first-line health care workersThe regulator again authorized the test to be extended to anyoneLabCorp provides scientific data showing that its tests can detect SARS-CoV-2 in general asymptomatic populationsIn addition, reauthorization includes allowing up to five samples to be combined and analyzed at once, and the sample pool allows for less testing overall, saving resources and potentially evaluating more samples faster and speeding up screeningMost diagnostic methods have not been proven to be accurate enough, including unacceptable false positive or negative results, and cannot screen large populationsAccording to the FDA review, labCorp tests were as accurate in a wider range of asymptomatic populations as those in suspected COVID-19"The FDA's authorization of the first diagnostic test for anyone is a step toward extensive screening that can help ensure the safety of employees, patients, students and others," FDA Director Stephen MHahn said in a statementAt the same time, combining samples increases the likelihood that patients will get results more quickly and save important test supplies"The FDA last week sent the first EUA for sample consolidation testing to QuestDiagnostics, in preparation for a new long-term monitoring phase for the U.Sresponse to an influenza pandemicOverall, LabCorp and Quest provide more than half of the U.Scommercial lab testing services However, the bulk testing strategy works best in areas with low virus prevalence, and it retains the test to individuals until the first test returns a positive result But in many parts of the United States, infection rates are still soaring, with tens of thousands of new cases added every day It is understood that the current Quest and LabCorp tests still need a prescription In addition, LabCorp cautions that negative results from mixed tests should not be considered certain, as this approach reduces the sensitivity of the test In addition, only swabs collected by medical professionals can be tested as a batch
This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only.
This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of
the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed
description of the concern or complaint, to
service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content
will be removed immediately.