Quick! Get Tested At Home
- Compliance Insight
- Mar 3, 2021
- 1 min read
FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test

On March 1, 2021, the FDA authorized another antigen for at-home sample collection and visual results without sending it to a lab for processing: Quidel’s QuickVue At-Home COVID-19. The test is prescribed by a healthcare provider within the first six days of symptom onset and is approved for individuals aged 14 years or older for self-collection and individuals aged 8 to thirteen years old with a sample collected by an adult. Both positive and negative tests should prompt self-isolation and follow up with your healthcare provider for next steps which could include a molecular test to verify results. It should be noted that the Quidel QuickVue test cannot differentiate between SARS-CoV and SARS-CoV-2.
The letter of authorization for the QuickVue At-Home COVID-19 Test goes into detail on performing the test correctly. Patients should review the instructions carefully before initiating test. The test includes “swabs, test strips, pre-filled tubes, a tube holder, instruction sheet, and Fact Sheet for Patients.” The steps are as follows:
Remove cap from pre-filled tube
Remove anterior nasal swabs from packaging
Self-collect specimen using swab
Insert swab into pre-filled tube and twirl or stir
Leave swab in tube for one minute and then remove
Insert test strip into tube for 10 minutes
Interpret results based on guide on instructions (presence or lack of purple/pink lines, including control line)
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