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Ordering Inquiries for Pilot COVID-19 At-Home Test

COVID-19 At-Home Test

The Pilot COVID-19 At-Home Test:
Accuracy Matters

93.2% relative sensitivity and 100% relative specificity


The accuracy of the Pilot COVID-19 At-Home Test provides you with a result you can trust and the confidence you need to take control.  Whether you're responsible for on-campus students, employee testing programs, large scale events this test provides you with the accuracy you need.

When you need a COVID-19 test, Accuracy Matters.

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Interested in bulk orders for your Healthcare facility or business?

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About the Test

Benefits of Home Testing

Download the Quick Reference Instructions

Test Specifications

Pilot COVID-19 At-Home Test characteristics

  • Assay format

    Lateral flow test / immunochromatographic

  • Instrument

    No

  • Testing time

    20-30 minutes

  • Positive Percent Agreement

    93.2%

     

     

     

     

     

     

     

  • Negative Percent Agreement

    100%

     

     

     

  • Antigen

    Nucleocapsid (N)

  • Sample material

    Nasal Swab
COVID-19 At-Home Test

Kit content overview

Your Pilot COVID-19 At-Home Test kit
contains the following components:

  1. Test device (x4)
  2. Buffer tube holder (x1)
  3. Nasal swab (x4)
  4. Tube with liquid (x4)
  5. Nozzle cap (x4)
  6. Quick Reference Instructions

The key benefits of the
Pilot COVID-19 At-Home Test

The benefits for society, healthcare systems and workers:

  • Testing is possible everywhere: Decentralized testing minimizes the possibility of exposure of healthcare workers to potentially infected individuals while protecting healthcare capacity.
  • A tool to safely re-open the economy: Tested individuals might be able to travel and participate in events, while reducing the risk of spreading the virus.
  • Real-world evidence: Independent performance studies with large sample sizes, including professional collection, self-collection and self-testing groups.
 

The benefits for the general public:

  • Reliable answers: High test quality and performance.1
  • Quick results: Faster results compared to laboratory testing.
  • Easy repetitive testing: No need to visit a healthcare professional or schedule an appointment.
  • Easy handling procedure: Reduced handling errors and waste.
  • Increased user protection: Virus inactivation by extraction buffer after 2 minutes.
  • Peace of mind: Worrying symptoms can be put into perspective.
 

Additional Resources

Related information

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    ...

    This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of this product 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 the declaration is terminated or authorization is revoked sooner.

    References

    1. Pilot COVID-19 At-Home Test Package Insert
    2. Su S, Wong G, Shi W, et al.-Trends Microbiol. 2016;24(6):490–502.-2016-Elecsys Anti-SARS-CoV-2 -L (v1.0)
    3. Zhu, N., Zhang, D., Wang, W. et al.-N Engl J Med 382(8) 727-733-2020-Elecsys Anti-SARS-CoV-2 -Lit (v1.0)
    4. Chan, J.F., Yuan, S., Kok, K.H., To, K.K., Chu, H., Yang, J. et al.-Lancet. 395, 514–523.-2020- El (v1.0)
    5. U.S. CDC. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. Published April 2, 2021. Accessed June 11, 2021. 
    6. WHO. https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations. Published March 29, 2020. Accessed June 11, 2021
    7. Kampf, G., Todt, D., Pfaender, S., Steinmann, E.-J Hosp Infect. 104(3), 246–251.-2020- Elecsys Ant (v1.0)
    8. Letko, M., Marzi, A., Munster, V. (2020).-Nat Microbiol. 1–8. doi:10.1038/s41564-020-0688-y.-2020- (v1.0)
    9. Hoffmann, M., Kleine-Weber, H., Schroeder, S. et al.-[published online ahead of print, 2020 Mar 4]. (v1.0)
    10. WHO. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200403- sitrep-74-covid-19-mp.pdf. Published April 3, 2020. Accessed June 11, 2021. 
    11. Lauer SA et al.-Ann Intern Med 2020;172(9):577-82-The Incubation Period of COVID-19 (v1.0)
    12. Rothe, C et al-N Engl J Med 2020;382(10):970-971-2020-Lab Infectious Diseases Respiratory tract infec (v1.0)
    13. Kupferschmidt K-Science. https://www.sciencemag.org/news/2020/02/paper-non symptomatic-patienttrans (v1.0)
    14. Bai Y et al-JAMA 2020;323(14):1406-1407-2020-Lab Infectious Diseases Respiratory tract infections Co (v1.0)
    15. Mizumoto K et al-Euro Surveill 2020;25(10):2000180.-2020-Lab Infectious Diseases Respiratory tract (v1.0)