Quidel 20387 QuickVue SARS Covid 19 Antigen Rapid Test Kit -
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QuickVue SARS Covid 19 Antigen Rapid Test Kit - Box of 25

SKU: MD551341
MFG Part#: 20387
In Stock
This product is non returnable
Sale:

$164.51

25 / Kit
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What's In The Box:
  • (25) Individually Packaged Test Strips
  • (25) Reagent Tubes
  • (25) Vials of Reagent Solution with 340 µL Salt Solution
  • (25) Sterile Nasal Swabs
  • SARS Positive Control Swab
  • Negative Control Swab
  • Package Insert
  • Procedure Card
Manufacturer’s Downloads
Description

The QuickVue SARS Antigen Test has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This 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.

Features
  • Dipstick test format.
  • Results in 10 minutes.
  • Two-color result.
  • All components are included in the kit.
  • Room temperature storage.
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Product Specifications
Sample type: Anterior nares swab
Time to results: 10 minutes
Kit storage conditions: Room temperature (15°C to 30°C/59°F to 86°F)
Country of Origin: USA
External controls: Positive and negative included
PPA (Reference Extracted SARS-CoV-2 RT-PCR Assay): 96.6%
NPA (Reference Extracted SARS-CoV-2 RT-PCR Assay): 99.3%
CLIA complexity: Waived
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Frequently Asked Questions (FAQs)
The test kit uses lateral flow immunoassay technology to detect specific proteins (antigens) from the SARS-CoV-2 virus in nasal swab specimens. The test kit contains all the necessary components, and the sample is added to the test device, where it interacts with antibodies to produce a visible line if the virus is present.
The QuickVue SARS-CoV-2 Antigen Rapid Test Kit has demonstrated high accuracy in detecting SARS-CoV-2 infections. However, like any diagnostic test, there is a possibility of false positives or false negatives. It is crucial to follow the instructions carefully and consult healthcare professionals for further confirmation or guidance.
The QuickVue SARS-CoV-2 Antigen Rapid Test Kit is intended for professional use in clinical settings.
The QuickVue SARS-CoV-2 Antigen Rapid Test Kit provides results in approximately 10 minutes after the sample is applied to the test device. It offers a quick turnaround time compared to some other diagnostic tests, allowing for prompt decision-making and management of potential COVID-19 cases.
The QuickVue SARS-CoV-2 Antigen Rapid Test Kit has obtained emergency use authorization (EUA) from regulatory agencies such as the U.S. Food and Drug Administration (FDA) for its specific use in certain situations.
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