Quidel QuickVue At-Home OTC Covid-19 Test - Nasal Swab, 10 Minute Rapid Results

Who Uses This Product? The at-home antigen test can be self-performed by individuals ages 14 years and older. An adult must perform specimen collection for children 2 to 13 years of age.

Why Give It a Try? It is a simple nasal swab test that provides straightforward results in just 10 minutes.

Overview

The Quidel QuickVue At-Home OTC Covid-19 Test is a test that detects the nucleocapsid protein antigen from SARS-CoV-2 and provides rapid results within 10 mintues. Using an at-home test is beneficial for individuals who are exhibiting symptoms to determine infection status. It is also ideal for the screening of asymptomatic individuals. The antigen test provides a convenient, cost-effective option when a negative test result is required prior to travel or surgery.

The QuickVue Antigen OTC Test kit makes it simple and easy to self-perform or administer to another person. The nasal specimen is collected and inserted into a pre-filled vial to ensure hassle-free testing. There is no measuring, dispensing, or second-guessing if the correct amount of solution was added. Best of all, there is no sending off the test to a lab to wait for results.

The Quidel QuickVue At-Home OTC Covid-19 Test strip provides straightforward results within 10 minutes. If the protein is present, a pink and blue line indicates a positive test result and a single blue line is negative. Note: The kit contains two tests so that a second test can be performed within three days of the initial test.

Features and Benefits

• Convenient At-Home Test
• No Measuring or Counting Drops
• Fast Results Without Sending Specimen to the Lab
• Three-Step Process
• Results Within 10 Minutes
• Made in the USA
• No Prescription Required

Product Specifications

• Manufacturer: Quidel
• Brand: QuickVue
• Product Number: 20402
• Detects: Nucleocapsid Protein Antigen
• No. of Tests: 2
• Test Type: Antigen Test
• Test Results: Visual/10 Minutes
• Sample Type: Nasal Swab
• Rx Required: No
• Application: For Use Under an Emergency Use Authorization (EUA)¹

Cautions for QuickView AT-Home OTC Test

• Positive results indicate the presence of viral antigens. The individual's medical history and other diagnostic information must also be considered to determine infection status.
• Positive results do not rule out bacterial infection or co-infection with other viruses. Individuals who test positive with the QuickVue At-Home OTC Antigen Test should self-isolate and seek follow-up care with their physician or healthcare provider.
• Negative results should be treated as presumptive; do not rule out SARS-CoV-2 infection when making infection-control decisions.
• The kit is authorized for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
• Results are intended to be read at 10 minutes; if the test is read before this timeframe or it is read more than five minutes after the indicated read-time, results may be inaccurate and the test should be repeated.

Manuals and Documents

•    Sell Sheet

Footnotes

• ¹ In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2." FDA - April, 22 2021