The story has been updated with information from Quidel and the NIH.
NEW YORK – The US Food and Drug Administration said on Monday it has issued Emergency Use Authorization for Quidel's QuickVue At-Home COVID-19 test.
The rapid, antigen test, which uses a lateral flow format, can be used by certain individuals to rapidly collect their samples at home without having to send them to a laboratory for analysis. The test is authorized for prescription home use with self-collected anterior nasal swabs from individuals 14 years or older and individuals as young as 8 years old with swabs collected by an adult, the FDA said.
The test is authorized for use for people suspected of having COVID-19 within the first six days of the onset of symptoms. In a statement Quidel said the test can return results in 10 minutes and it showed positive results that agreed with PCR testing 84.8 percent of the time and negative results that agreed with PCR results 99.1 percent of the time.
The test is the fourth rapid, antigen test for SARS-CoV-2 by Quidel to receive EUA from the FDA. The San Diego-based company received the first EUA for a rapid, COVID-19 antigen test last May.
Quidel further noted that it has started building out a new 128,000-square-foot manufacturing facility in Carlsbad, California, which is expected to begin operations in the second half of this year. Initially, it will produce more than 50 million QuickQue rapid, antigen tests per month, or 600 million each year, at full capacity.
Separately, the US National Institutes of Health said on Monday it has launched a study to evaluate the performanc and utility of a smartphone app for use with Quidel's QuickVue At-Home COVID-19 test, which was developed with support from NIH's Rapid Acceleration of Diagnostics (RADx) program. More than 200 participants have enrolled in the study which is assessing an app called MyDataHelps developed by CareEvolution. It would allow users to interpret their own test results while also providing an independent confirmation of the test result by photographing the test strip with a smartphone camera.