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Ustar Obtained the First EU CE Certificate for COVID-19 Nucleic Acid Self Test

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  • Time of issue:2022-04-27
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(Summary description)COVID-19 RNA Test, a single-use at-home self test developed by Ustar, has obtained CE IVD Self-Testing certificate.

[Top]

Ustar Obtained the First EU CE Certificate for COVID-19 Nucleic Acid Self Test

(Summary description)COVID-19 RNA Test, a single-use at-home self test developed by Ustar, has obtained CE IVD Self-Testing certificate.

  • Categories:Latest News
  • Author:
  • Origin:
  • Time of issue:2022-04-27
  • Views:0
Information

April 22, 2022 ---COVID-19 RNA Test, a single-use at-home self test developed by Ustar, has obtained CE IVD Self-Testing certificate (EC Certificate No.1434-IVDD-109/2022).

The COVID-19 RNA Test is the first EU CE-approved nucleic acid self test for COVID-19, which means this self-test product now has an access to 27 European Union Member States and countries that recognize the EU CE certification. You can also buy it in pharmacies, stores and online platforms.

Back to April 2021, the COVID-19 RNA Test for professional use was registered in European market. Since then, it has been exported to Germany, France, the United Kingdom, Spain, Italy and totally over 30 countries and regions, and gained good feedback from our customers.

In 2022, a clinical study* of the COVID-19 RNA Test was carried out in European labs and results indicated that: compare with RT-PCR,

-Sensitivity≥95.4%, Specificity≥99.8%

-Positive percent agreement=95.4% (97.8% for Ct value ≤ 35; 81.3% for CT value > 35)

-Negative percent agreement=99.8%

-Overall percent agreement=99.0%

-Samples with CT value of 39.26 could be detected successfully

At present, another clinical trial of this test is ongoing in the United States.

*Ustar clinical evaluation report (2021.9-2022.1)

 

The COVID-19 RNA Test integrates nucleic acid lysis, extraction, amplification and detection in a portable and compact test cassette.

-Simple operation: less than 2 minutes of hands-on time, you can get the result in 35 minutes

-Accurate: LoD=3,000 copies/mL

-Sensitive: detect major SARS-CoV-2 variants, including Alpha, Beta, Delta and Omicron

Enable a rapid and accurate self testing accessible at home.

  In addition to the COVID-19 test, our self testing platform is going to be compatible with extensive testing items, including flu, sexually transmitted infections, veterinary diagnosis and food safety.

Ustar Biotechnologies (Hangzhou) Ltd, a leading point-of-care molecular diagnosis provider for tuberculosis, COVID-19, malaria and other major communicable diseases. With continuous investment in research and development, we aim to provide more affordable and better solutions for the prevention and control of human communicable diseases, as we stated as our core value: molecular testing, anywhere!    

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Contact us

Ustar Biotechnologies (Hangzhou) Ltd.  (Headquarters)
Add: 6/F, Building 2, 611 Dongguan Road, Binjiang District, Hangzhou, Zhejiang, P.R. China
Zip: 310053

Email: sales@bioustar.com    service@bioutsar.com
Tel: +86-571-88939358 (Sales) 
       +86-400-870-7025 (Service)

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