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FDA grants EUA to Quidel’s at-home Covid-19 test

02 Mar 2021 (Last Updated March 2nd, 2021 11:38)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Quidel’s QuickVue At-Home COVID-19 Test.

FDA grants EUA to Quidel’s at-home Covid-19 test
The test can qualitatively detect the nucleocapsid protein antigen from SARS-CoV-2 and provide results in ten minutes. Credit: Jarun Ontakrai / Shutterstock.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Quidel’s QuickVue At-Home COVID-19 Test.

The test can qualitatively detect the nucleocapsid protein antigen from SARS-CoV-2 and provide results in ten minutes. It needs a doctor’s prescription.

The test is authorised for use at home with self-collected anterior nares (NS) swab samples from people aged 14 years and older suspected of Covid-19 by a healthcare provider in the first six days of symptom onset.

Furthermore, the QuickVue At-Home COVID-19 Test can be used for adult-collected anterior NS specimens from those aged eight years and older suspected of the disease.

Quidel president and CEO Douglas Bryant said: “The flexibility of our QuickVue At-Home COVID-19 Test for meeting the urgent testing needs of individuals at home will save time and enable doctors and telemedicine providers to determine appropriate treatments without exposing their staff and other patients to a heightened risk of infection.”

Meanwhile, the National Institutes of Health-funded researcher team has begun a study to evaluate the performance and usability of a smartphone app, MyDataHelps, paired with the QuickVue At-Home COVID-19 Test.

Developed by CareEvolution, the app offers step-by-step instructions for carrying out the test and tools such as timers to guarantee that the steps are performed at accurate time intervals.

So far, the study has enrolled more than 200 subjects who will be tested daily for two weeks.

Last month, Quidel opened a new manufacturing facility for the mass manufacture of the company’s QuickVue SARS rapid antigen tests for Covid-19.

In a separate development, the FDA has granted EUA to Eurofins’ Clinical Enterprise’s direct-to-consumer (DTC) version of EmpowerDX COVID-19 Home Collection Kit.

With the authorisation, Eurofins can now market the test kit directly to consumers without requiring a prescription.

The kit consists of instructions, a shallow nasal swab, a test tube, and a pre-paid FedEx package for an easy return of specimens.

Users can access the test results from a secure patient portal in 48 hours.