QuickVue At-Home OTC COVID-19 Test kit

Product Description

Results in just 10 minutes

Least expensive COVID-19 test

Non-invasive design

For home, office, schools, shelters, etc.

No prescription required

Easy and straightforward results

Includes 2 nasal swab tests

Made in the USA

For Use Under an Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2

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 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 aged 2 years or older

Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status

Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the QuickVue At-Home OTC COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary

Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions

Negative results should be considered in the context of an individuals recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management

Individuals should provide all results obtained with this product to their healthcare provider for public health reporting

This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens

The test is intended to be read at 10 minutes; If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate and the test should be repeated

Quantity : 2 Covid-19 Tests per Box

Time To Results : 10 Minutes

Test Type : Antigen Test

Contents : Individually Wrapped Sterile Foam Swabs, Individually Packaged, (2) Single-Use Test Strips, Pre-Filled Tubes, Tube Holder, Instruction & Fact Sheets

Reading Type : Visual Read

Sample Type : Direct Anterior Nasal (NS) Swab Sample

Test Format : Test Strip Format

Test Method : Lateral Flow Immunoassay