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Description

The LifeSign Status COVID-19 Antigen Rapid Test for Home Use is a lateral flow, rapid immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-Cov-2. This OTC (over-the-counter) test includes an anterior nasal swab that provides comfortable and easy collection.

Warranty: Until Use or Expiration.

The test is authorized for individuals with symptoms of COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.

Features

LifeSign Status COVID-19 Antigen Rapid Test for Home Use Features

  • FDA Emergency use authorization (EUA).
  • For home use, workplace, school, and clinics.
  • Visually read results in 15 minutes.
  • For individuals aged 14 years or older or adult-collected anterior nasal swab samples from individuals aged two years or older.

Package Quantities

LifeSign Status COVID-19 Antigen Rapid Test for Home Use Package Quantities

  • #33301: Box of One.
  • #33302: Box of Two.
  • #33325: Box of 25.

Frequently asked questions

How fast are the results for this rapid test?

This antigen rapid test provides visually readable results in just 15 minutes. This quick turnaround time makes it ideal for rapid screening in home, workplace, or school settings.

Does this test have FDA authorization?

Yes, the LifeSign Status COVID-19 Antigen Rapid Test is authorized under FDA Emergency Use Authorization (EUA). This designation confirms its suitability for various testing environments, including home use, workplaces, schools, and clinics.

Does this test detect the nucleocapsid protein?

Yes, the LifeSign Status COVID-19 Antigen Rapid Test is a lateral flow immunoassay specifically designed for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen. This is the target analyte used in the rapid test to determine the presence of the virus.

What is the recommended age range for using this test?

This test is authorized for individuals aged 14 years or older. For children aged two years or older, an adult must collect the anterior nasal swab sample.

Does this test deliver rapid results?

Yes, this is a rapid immunoassay designed to provide quick results. You will get visually readable results in just 15 minutes after performing the anterior nasal swab.

Does the test use rapid lateral flow technology?

Yes, the LifeSign Status COVID-19 Antigen Rapid Test uses lateral flow, rapid immunoassay technology.

This assay is designed for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen using a comfortable anterior nasal swab. The results are quick, providing a visual reading in just 15 minutes.

Is this test authorized for asymptomatic screening?

Yes, the LifeSign Status COVID-19 Antigen Rapid Test is authorized for screening both symptomatic and asymptomatic individuals under FDA Emergency Use Authorization (EUA). The test provides visually readable results in just 15 minutes and uses a comfortable anterior nasal swab.

The specific testing protocols authorized are:

  • Symptomatic Individuals: Test twice over three days, with tests taken 48 hours apart, starting within the first five days of symptom onset.
  • Asymptomatic Individuals: Test three times over five days, with tests taken 48 hours apart.
Is the LifeSign rapid test authorized for multiple settings?

Yes, the LifeSign Status COVID-19 Antigen Rapid Test is highly versatile and holds FDA Emergency Use Authorization (EUA) for over-the-counter (OTC) use in multiple environments.This authorization allows for rapid screening and diagnostic assessment in the following settings:

  • Home use
  • Workplaces
  • Schools
  • Clinics

This broad scope of use ensures flexibility for testing wherever it is most needed.

Does this test use a comfortable nasal swab?

Yes, the LifeSign Status COVID-19 Antigen Rapid Test is designed for user comfort. It utilizes an anterior nasal swab for comfortable and easy sample collection, making it ideal for home use.

Is this test a complete, all-in-one kit?

Yes, the LifeSign Status COVID-19 Antigen Rapid Test is designed as a complete, self-contained kit for Over-The-Counter (OTC) use. It includes everything necessary to perform the rapid immunoassay for SARS-CoV-2 antigen detection.

Key components included for each individual test unit (whether you select a Box of One, Two, or 25) are:

  • The rapid test device (cassette)
  • The comfortable anterior nasal swab for easy sample collection
  • Necessary reagents/buffer solution
  • Detailed instructions for use

This kit is highly convenient, delivering visually readable results in just 15 minutes, and it holds FDA Emergency Use Authorization (EUA).