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Home / News / Company News / Goldsite obtains CE self-testing certificate for the SARS-CoV-2 Nasal Antigen Self-Test

Goldsite obtains CE self-testing certificate for the SARS-CoV-2 Nasal Antigen Self-Test

Author: Scarlett     Publish Time: 2021-11-13      Origin: Site

Goldsite today announced it has received CE mark for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing. The test will be available in countries accepting the CE mark through pharmacies and other locations, in packs of 1/3/5/7/25 tests.


EC certificate for self testing


An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since May 2021 such as France. With the CE Mark, the SARS-CoV-2 Antigen Kit for Self Testing of COVID-19 test with nasal swab has received official approval following the traditional registration pathway (based on the Directive 98/79/EC of EU AKA IVDD Annex III, paragraph 6 or Annex IV, paragraph 3 and Annex VII)and can now also be used in markets that have not established regulatory exemption pathways.

By following simple instructions, individuals can perform the test at home using a nasal swab without special training or the supervision of a healthcare worker. The test provides results in as little as 12 minutes and can help people to conveniently check if they are likely to be infectious from the comfort of their home.


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Main Features of Goldsite SARS-CoV-2 ATK for self-test

  • EASY. No special equipment and expertise needed.

  • Accurate. Clinical performance of sensitivity and specificity: 100%, 97.17%

  • RAPID. Only 12 mins waiting time.

  • Nasal, nasopharyngeal and oropharyngeal swabs acceptable

  • Good correlation with RT-PCR detection.

  • Room temperature storage


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Goldsite Diagnostics Inc., founded in 1999, is a leading Chinese diagnostics manufacturer specializing in in-vitro diagnostics devices and reagents.

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