COVID-19 At-Home Test

Testing the quick and easy way

 

The COVID-19 At-Home test further expands and decentralizes testing and allows for safer decision making by providing reliable results everywhere, with no medical assistance needed. It can potentially benefit various parties from individuals to healthcare systems.

The benefit of having a SARS-CoV-2 antigen test available

 

The SARS-CoV-2 virus causes respiratory tract infection. It is transmitted mainly via respiratory droplets after close contact, and primary viral replication is presumed to occur in mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx).2 At these locations viral load peaks within the first week after symptom onset, and then declines.3

A SARS-CoV-2 antigen test detects the presence of the SARS-CoV-2 virus from part of the upper respiratory tract swab specimens by identifying a nucleoprotein that is carried by the virus. The test identifies current infection during the acute phase of COVID-19, while the virus is still present in large quantities in the respiratory tract.

At Roche Diagnostics we believe wide accessibility to such high-performance, instrument-free and reliable Point of Care tests can contribute significantly to better managing the ongoing pandemic crisis.

The key benefits of the
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.

Kit content overview

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

  1. Test device 
  2. Buffer tube holder
  3. Nasal swab 
  4. Buffer tube 
  5. Nozzle cap 
  6. Quick Reference Instructions

SARS-CoV-2: An overview of virus structure, transmission and detection

 

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an enveloped, single-stranded RNA virus of the family Coronaviridae. Coronaviruses share structural similarities and are composed of 16 nonstructural proteins and 4 structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). Coronaviruses cause diseases with symptoms ranging from those of a mild common cold to more severe ones such as Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.2,3

SARS-CoV-2 is transmitted from person-to-person primarily via respiratory droplets, while indirect transmission through contaminated surfaces is also possible.4-7 The virus accesses host cells via the angiotensin-converting enzyme 2 (ACE2) receptor, which is most abundant in the lungs.8,9

The incubation period for COVID-19 ranges from 2 - 14 days following exposure, with most cases showing symptoms approximately 4 - 5 days after exposure.4,10,11 The spectrum of symptomatic infection ranges from mild (fever, cough, fatigue, loss of smell and taste, shortness of breath) to critical.12,13 While most symptomatic cases are not severe, severe illness occurs predominantly in adults with advanced age or underlying medical comorbidities and requires intensive care. Acute respiratory distress syndrome (ARDS) is a major complication in patients with severe disease. Critical cases are characterized by e.g., respiratory failure, shock and/or multiple organ dysfunction, or failure.12,14,15

Coronavirus illustration
  • Nucleocapsid protein (N)
  • Envelope protein (E)
  • Spike protein (S)
  • Membrane glycoprotein (M)
  • RNA

An aid in identifying individuals infected by SARS-CoV-21

 

The COVID-19 At-Home Test is a lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human nasal samples. This test is used to detect antigens of the SARS-CoV-2 virus in individuals suspected of having COVID-19 and is designed as a self-test.

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*COVID-19 At-Home Test has not been FDA cleared or approved in the United States. This test has been authorized by FDA under an EUA for use by authorized laboratories to be distributed and used in professional test locations outsides of the clinical laboratory environment. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.

References
 

  1. 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)

COVID-19 At-Home Test characteristics

  • Assay format

    Lateral flow test / immunochromatographic

  • Instrument

    No

  • Testing time

    20-30 minutes

  • Positive Percent Agreement

    95.3%

     

     

     

     

     

     

     

  • Negative Percent Agreement

    100%

     

     

     

  • Antigen

    Nucleocapsid (N)

  • Sample material

    Nasal Swab

*COVID-19 At-Home Test has not been FDA cleared or approved in the United States. This test has been authorized by FDA under an EUA for use by authorized laboratories to be distributed and used in professional test locations outsides of the clinical laboratory environment. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.