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QuickVue at-Home OTC COVID-19 Test Kit

On Backorder

SKU: QU20398-MI
$42.00 to $315.00

Notice: This item is strictly non-returnable.

QuickVue At-Home OTC COVID-19 Test lets you get rapid results, in the privacy of your own home. Available over-the-counter, everything you need is in the package and taking the test is simple. QuickVue At-Home OTC COVID-19 Test utilizes trusted technology used for decades by healthcare professionals and makes simple, easy-to-use COVID-19 tests accessible for the good of our families, our communities and the world. The test is authorized for home use with self-collected anterior nasal (nares) swab samples in individuals aged 2 and older. This test is also authorized for home use for individuals aged 2 through 14 with an adult performing the test. The test is intended to be used twice over two to three days, with at least 24 hours and no more than 36 hours between tests. Take 10 Minutes. Take Charge. Fast. Easy. Ready When You Are.

Features

  • The test uses a gentle self-collected anterior nasal (nares) swab sample to determine a positive or negative COVID-19 result. The swab is swirled in a tube of reagent solution, then removed, before a test strip is inserted. After ten minutes, you can take the strip out of the tube and see your results.
  • In a clinical study, the QuickVue At-Home OTC COVID-19 Test identified positive cases 83.5% of the time, and identified negative cases 99.2% of the time(83.5% PPA, and 99.2% NPA, respectively), when compared to PCR.
  • 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 aged 2 years 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.
QuickVue At-Home OTC COVID-19 Test Kit
Sample typeAnterior nares swab
Time to results10 minutes
Shelf life24 months from date of manufacture
Kit storage conditions Room temperature (15°C to 30°C/59°F to 86°F)
Internal controlsIncluded
External controlsPositive and negative included
CLIA complexityWaived*
PPA (Reference Extracted SARS-CoV-2 RT-PCR Assay)96.6%
NPA (Reference Extracted SARS-CoV-2 RT-PCR Assay)99.3%
  • The product warranty is applicable as per the terms and conditions provided by the product manufacturer.

Please call us for specific details.

Notice: This item is strictly non-returnable.