SARS-CoV-2 Antigen Self Test Nasal

SARS-CoV-2 Antigen Self Test Nasal
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An aid in identifying individuals infected by SARS-CoV-21

 

The SARS‐CoV‐2 Antigen Self Test Nasal 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 for the general public.

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

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 SARS-CoV-2 Antigen Self Test Nasal

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.
SARS-CoV-2 Antigen Self Test Nasal

Testing the quick and easy way

 

Testing process for the SARS-CoV-2 Antigen Self Test Nasal1

Make sure to follow the steps below carefully

Make sure to follow the steps below carefully

Always read the Instructions for Use carefully.

icon wash hands

Wash your hands...

icon use sanitizer

... or use hand sanitizer.

icon prepare materials

Place the needed material in front of you.

icon keep a timer

Keep a timer to track the readout time.

Always read the Instructions for Use carefully.

icon collect sample

Collect Nasal Sample

Blow your nose once using a tissue. Open swab packet and make sure to only hold the swab at the bottom. Do not touch the tip. Insert the sterile swab 2 cm into your nostril and rotate the swab 4 times for about 15 seconds against the nasal wall.

icon collect sample

Repeat process

in the other nostril with the same swab.

icon prepare sample

Prepare the sample

Insert the swab into the extraction buffer tube, squeeze the tube tight at the bottom and stir the swab more than ten times.

icon remove swab close the tube

Remove the swab

while squeezing the sides of the tube. Press the nozzle cap tightly onto the tube.

Always read the Instructions for Use carefully.

icon add drops

Add 4 drops of extracted sample to the specimen well of the test device.

icon set timer

Set timer and read the results after 15 minutes and before 30 minutes have passed.

icon keep a timer

Risk of incorrect results. Do not read test result after 30 minutes.

icon read out time

15 - 30 min

Control line C

Confirms the test is working correctly

Test line T

Visible if SARS-CoV-2 antigen was detected

Positive

Positive result

Negative

Negative result

Invalid

Invalid result
Positive test result

If both the colored line C and T are visible the test result is positive. This means the test detected the virus protein in the sample. The tested person is likely infected with SARS-CoV-2.

 

What now?
icon

You need to self-isolate immediately.

icon

Contact your doctor and...

icon

... you may be required to undergo a PCR test to confirm the test result.

Negative test result

A visible control line C means the test worked correctly. The test result is negative. There was no virus protein detected in the sample.
 

 

What now?
icon

There is a very low chance you are currently infectious to others.

icon

Note that this result is only valid for the day you take the test.

icon

Continue to follow the hygiene guidelines.

Invalid test result

If there is no line visible, or only the line marked with a T, the test did not work correctly and needs to be repeated with another test device.
 

 

What now?
icon

To get a valid result you will have to do a new test (with new test material and new sample).

icon

Make sure to follow the instructions carefully.

References
 

  1. SARS-CoV-2 Antigen Self Test Nasal Package Insert 2021-04 V 1.0
  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 Juen 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)

SARS-CoV-2 Antigen Self Test Nasal Test characteristics

  • Assay format

    Lateral flow test / immunochromatographic

  • Instrument

    No

  • Testing time

    15-30 minutes

  • Specificity

    99.6%

     

  • Sensitivity

    91.1% (Ct value ≤ 30)

     

  • Antigen

    N

  • Sample material

    Nasal Swab

  • Reagents

    mAb anti-COVID19 antibody, mAb anti-Chicken IgY, mAb anti-COVID-19 antibody‑gold conjugate, Purified chicken IgY‑gold conjugate