FDA Approves First Home-Use Rapid Screening Unit for New Coronary Pneumonia; the results will be known in 30 minutes | TechNews 科技 新 报



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Facing the second wave of the epidemic, the number of daily diagnoses in the United States continued to set a record. Many experts worry that the upcoming Thanksgiving will cause another spike in infections. The United States Food and Drug Administration (FDA) first released a new wreath for Lucira Health on the 17th. The rapid pneumonia detection team provides emergency clearance in hopes of helping stop the epidemic.

According to the FDA statement, the Lucira COVID-19 all-in-one test kit authorized for emergencies contains all the tools for COVID-19 testing at home, suitable for anyone over 14 years of age. use.

Similar to the steps carried out at the detection station, people must use cotton swabs to collect samples from inside the nose, place the cotton swabs in a vial bottle containing a special solution, and then Place the vial in the test device, which will pass through the light in 30 minutes. No. Confirm the result.

Although home rapid detection is quite convenient, this tool still requires a prescription for application. The physician who issued the rapid detection prescription should report the results to the public health department to help local authorities better assess the local transmission situation.

Like all rapid detection tools, Lucira’s rapid detection suite is not perfect and there may still be errors in judgment, but from the attached instructions, the new rapid detection can correctly distinguish 94% positive and 98% negative reactions . Excluding cases with extremely low virus levels, the positive accuracy can be as high as 100%.

The FDA has previously approved other rapid screening tools, but the Lucira rapid screening unit is the first test that can provide timely results. Although it is not 100% safe to help judge the outcome, when people have evidence to suspect they are infected, they will be able to more quickly isolate themselves and seek emergency testing and treatment to help contain the pandemic.

Michael Mina, an epidemiologist at Harvard University, said he believes that as long as as many Americans as possible are required to get tested each week, the pandemic in the United States is expected to be brought under control. If there are concerns about the results incorrect, other detection methods can also be used. Second confirmation.

Lucira All-in-One COVID-19 Quick Screen is understood to cost less than US $ 50 and will be manufactured locally in the United States. Initially provided to Sutter Health in Northern California and Cleveland Clinic in Miami, Florida (Cleveland Clinic Florida), it is estimated to be available throughout the United States in spring 2021.

(Source of the first image: shutterstock)





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