Press release:
Tops Friendly Markets is proud to offer the community an [PA1] at-home COVID-19 testing kit manufactured by industry leader Quidel and distributed by McKesson. The kit costs $24.95.
QuickVue® At-Home OTC COVID-19 Tests* by Quidel provides you with rapid results in the privacy of your own home. This fast, easy, over the counter COVID-19 test is ready when you are. Everything you need is included in the package and using the test is simple.
The test is authorized under an FDA EUA* for home use with a gentle self-collected anterior nasal swab sample for those ages 2 years and older to determine a positive or negative COVID-19 result. (Adults must perform the test for those 2 to 14 years of age.) The kit includes two tests, which should be used over two to three days with at least 24 hours and no more than 36 hours between tests.
How it works: The swab containing the nasal sample is swirled in a tube of reagent solution, then removed, before a test strip is inserted. After just 10 minutes, you can remove the test strip out from the tube and see your results. Wait at least 24 hours, but no more than 36 hours, to use the second test. Positive results may require further follow up with your physician.
In a clinical study, the QuickVue At- Home OTC COVID-19 Test identified positive cases 83.5 percent of the time, and identified negative cases 99.2 percent of the time when compared to molecular PCR results, the standard lab test that on average takes four to five days before receiving results [KL2]
Still looking to receive a COVID-19 Vaccine? Vaccine appointments are available at Tops Pharmacies for those 12 years of age and older (where available) who elect to be vaccinated. For more information or to schedule a visit www.Topsmarkets.com/COVID19
*The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests. This home test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals ages 2 or older.
This home test has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA) for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This home test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.§360bbb-3(b)(1), unless authorization is terminated or revoked sooner.
[PA1] Note – Added required EUA disclaimer language below. It is not approved.
[KL2] Somewhat misleading as the molecular PCR test does take more lab time, but getting results back are a matter of logistics.
