14 May 2021 - - US-based rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems provider Quidel Corp's (NASDAQ: QDEL) non-prescription QuickVue At-Home OTC COVID-19 Test is now available in the United States to consumers for online order through e-commerce retailer Amazon (NASDAQ: AMZN), the company said.

The QuickVue At-Home OTC COVID-19 Test allows consumers to easily perform the test themselves without a doctor's prescription and get results in 10 minutes from nasal swab samples.

The QuickVue At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% of the time, delivering confidence to individuals running the test and helping to prevent asymptomatic virus spread.

A 2-pack COVID test is currently available for sale on amazon.com for USD 24.95 with free shipping.
The QuickVue At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration's Emergency Use Authorization.

The QuickVue At-Home OTC COVID-19 Test has not been FDA cleared or approved.

The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Federal Food, Drug and Cosmetic Act, 21 USC. § 360bbb-3(b) (1), unless the declaration is terminated or authorization is revoked sooner.

Quidel is a manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe.

An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the US.

Under trusted brand names Sofia, Solana, Lyra, Triage and QuickVue, Quidel's comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.

With products made in America, Quidel's mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world.