The Food and Drug Administration has granted the primary emergency use authorization to diagnostic healthcare company Quidel Corp. for the first COVID-19 antigen test, the company announced. Antigen assessments can temporarily detect the coronavirus, but are usually regarded as less correct than other sorts of tests that seek out the virus.
Antigen assessments for COVID-19 are similar to fast flu or strep checks. This take a look at may also be run in a lab or in a doctor’s administrative center, and only takes about 15 minutes.
The exams in most cases used to diagnose COVID-19, called PCR tests, seek out the genetic collection of the coronavirus in a swab collected from a affected person’s nose or throat. Antigen tests, at the other hand, look for molecules at the surface of the virus. They return effects a lot more temporarily, however are much less correct. If the check says a affected person sample is positive, it’s more likely to be proper. However Quidel’s take a look at has a prime charge of fake negatives: it best accurately identifies patient samples that contains the coronavirus 85 % of the time, the company’s leader govt instructed the Wall Boulevard Journal.
The FDA says negative effects from an antigen test should be confirmed with a PCR take a look at.
Quidel’s CEO told the WSJ the corporate is ramping up manufacturing to extend manufacturing of the test, formally referred to as the Sofia 2 SARS Antigen FIA, with a function of producing 1 million every week.