Article

Roche Diagnostics SARS-CoV-2 Rapid Antigen Test

An aid in identifying individuals infected by SARS-CoV-215

 

The SARS-CoV-2 Rapid Antigen Test is a reliable, rapid chromatopgraphic immunoassay for the qualitative detection of specific antigens of SARS-CoV-2 present in the human nasopharynx. 

This test is an aid in detecting antigen from the SARS-CoV-2 virus in individuals suspected of COVID-19. This product is strictly intended for professional use in laboratory and Point of Care environment. 

Test kit information

 

The kit is ready for use and contains all equipment needed to perform a test.

 

The following components are needed for a test and included in the kit:

  • Test device (individually in a foil pouch with desiccant)
  • Extraction buffer tube
  • Nozzle cap
  • Sterile swap
  • Film (can be attached to the test device when performing outdoor testing) 
  • Instructions for use
  • Quick Reference Guide

 

SARS-CoV-2-Antigen-test-kit
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Testing the quick and easy way

 

Testing process for the SARS-CoV-2 Rapid Antigen Test15

Testing process

1. Collecting a sample (nasypharyngeal swab)

 

Insert a sterile swab into the patient's nostril, swab the surface of the posterior nasopharynx. Withdraw the swab from the nasal cavity.

Testing process

2a. Preparing a sample

 

Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab more than 5 times.

Testing process

2b. Preparing a sample

 

Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.

Testing process

2c. Preparing a sample

 

Press the nozzle cap tightly onto the tube. Continue with 3a. Performing a test.

Testing process

3a. Performing a test

 

Apply 3 drops of extracted sample to the specimen well of the test device.

Testing process

3b. Performing a test

 

Read the test result at 15 to 30 min.

Warning: Risk of incorrect results. Do not read the test result after 30 min.

Testing process

4. Interpreting results

 

A colored line appears in the top section of the result window to show that the test is working properly. This is the control line (C). Even if the control line is faint, the test should be considered to have been performed properly. If no control line is visible the test is invalid. 

In case of a positive result, a colored line appears in the lower section of the result window. This is the test line (T). Even if the test line is very faint or not uniform, the test result should be interpreted as a positive result.

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References

 

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  2. 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)
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  9. WHO. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200403- sitrep-74-covid-19-mp.pdf. Published April 3, 2020. Accessed April 15, 2020. 
  10. Lauer SA et al.-Ann Intern Med 2020;172(9):577-82-The Incubation Period of COVID-19 (v1.0)
  11. Rothe, C et al-N Engl J Med 2020;382(10):970-971-2020-Lab Infectious Diseases Respiratory tract infec (v1.0)
  12. Kupferschmidt K-Science. https://www.sciencemag.org/news/2020/02/paper-non symptomatic-patienttrans (v1.0)
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  15. SARS-CoV-2 Rapid Antigen Test Package Insert 2020-09, V 1.0.