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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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Ustar Obtained the First EU CE Certificate for COVID-19 Nucleic Acid Self Test
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COVID-19 RNA Test, a single-use at-home self test developed by Ustar, has obtained CE IVD Self-Testing certificate.
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SGF, Boss Mustapha (2nd) inspecting Covid-19 test kits donated by Ustar, MD, CGCOC, Ye Shuijin (2nd R) showcasing Covid-19 test kits, PS (GSO), Dr. Nnamdi Maurice and a staff with CGCOC The Federal Government’s fight against Covid-19 pandemic received a boost with the donation of Covid-19 diagnostic test kits by Ustar Biotechnologies Company of China, aimed at enhancing the country’s diagnostic testing capacity of Covid-19 Virus. The Secretary to the Government of the Federation and the Chairman, Presidential Steering Committee (PSC) on Covid-19, Boss Mustapha, while receiving the donation from the Managing Director of CGCOC Group, Ye Shuijin, on behalf of Ustar Biotechnologies (Hangzhou) Limited in his office, thanked the Chinese biotechnological company for supporting the nation in the fight against Covid-19 pandemic. SGF said the donation of one set of the Nucleic Acid Amplification and Detection Analyzer (4-modules) with 500 diagnostic kits by the Company was timely as the nation is currently battling with the third wave of the Covid-19 pandemic as a result of the Delta Variant. According to him, the Covid-19 diagnostic test kits donated by Ustar biotechnologies Ltd have high capacity of rapid diagnostic tests of Covid-19 virus within a shortest time-frame. He added that the test kits will go a long way to boost the nation’s testing capacity as it grapples with the third wave of Covid-19 pandemic. He assured the Company that the PSC would ensure proper use of the test kits in ensuring that people know their status so as to mitigate the scourge of the pandemic. The Chairman stated that the PSC on Covid-19 is working out a protocol that would ensure equitable distribution of the 5 million Covid-19 vaccine to all eligible Nigerians across the country. He therefore, enjoined all eligible Nigerians to make sure they are vaccinated as the nation has flagged off its second phase of Covid-19 vaccination and to also abide by the laid down non-pharmaceutical interventions. Speaking earlier, the Managing Director of China Geo-engineering Company Overseas Construction Group Co. Ltd (CGCOC), Ye Shuijin, assured the SGF that the Covid-19 test kits are safe and effective in testing Covid-19 virus, saying the National Agency for Food and Drugs Administration and Control (NAFDAC) has given approval for use. He added the donation of the diagnostic test kits are borne out of the Company’s desire to assist the staff of the Office of the Secretary to the Government of the Federation on Covid-19 test. He also said that the testing machines have the capacity to deliver Covid-19 results within 15 minutes and are cost effective. Ustar Biotechnologies (Hanzhou) Ltd is a Chinese Biotechnological Company and a provider of molecular diagnostic overall solution and has focused on rapid nucleic and diagnostic technology research and application innovation. Willie Bassey Director (Information) 17 August, 2021
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SGF, Boss Mustapha (2nd) inspecting Covid-19 test kits donated by Ustar, MD, CGCOC, Ye Shuijin (2nd R) showcasing Covid-19 test kits, PS (GSO), Dr. Nnamdi Maurice and a staff with CGCOC The Federal Government’s fight against Covid-19 pandemic received a boost with the donation of Covid-19 diagnostic test kits by Ustar Biotechnologies Company of China, aimed at enhancing the country’s diagnostic testing capacity of Covid-19 Virus. The Secretary to the Government of the Federation and the Chairman, Presidential Steering Committee (PSC) on Covid-19, Boss Mustapha, while receiving the donation from the Managing Director of CGCOC Group, Ye Shuijin, on behalf of Ustar Biotechnologies (Hangzhou) Limited in his office, thanked the Chinese biotechnological company for supporting the nation in the fight against Covid-19 pandemic. SGF said the donation of one set of the Nucleic Acid Amplification and Detection Analyzer (4-modules) with 500 diagnostic kits by the Company was timely as the nation is currently battling with the third wave of the Covid-19 pandemic as a result of the Delta Variant. According to him, the Covid-19 diagnostic test kits donated by Ustar biotechnologies Ltd have high capacity of rapid diagnostic tests of Covid-19 virus within a shortest time-frame. He added that the test kits will go a long way to boost the nation’s testing capacity as it grapples with the third wave of Covid-19 pandemic. He assured the Company that the PSC would ensure proper use of the test kits in ensuring that people know their status so as to mitigate the scourge of the pandemic. The Chairman stated that the PSC on Covid-19 is working out a protocol that would ensure equitable distribution of the 5 million Covid-19 vaccine to all eligible Nigerians across the country. He therefore, enjoined all eligible Nigerians to make sure they are vaccinated as the nation has flagged off its second phase of Covid-19 vaccination and to also abide by the laid down non-pharmaceutical interventions. Speaking earlier, the Managing Director of China Geo-engineering Company Overseas Construction Group Co. Ltd (CGCOC), Ye Shuijin, assured the SGF that the Covid-19 test kits are safe and effective in testing Covid-19 virus, saying the National Agency for Food and Drugs Administration and Control (NAFDAC) has given approval for use. He added the donation of the diagnostic test kits are borne out of the Company’s desire to assist the staff of the Office of the Secretary to the Government of the Federation on Covid-19 test. He also said that the testing machines have the capacity to deliver Covid-19 results within 15 minutes and are cost effective. Ustar Biotechnologies (Hanzhou) Ltd is a Chinese Biotechnological Company and a provider of molecular diagnostic overall solution and has focused on rapid nucleic and diagnostic technology research and application innovation. Willie Bassey Director (Information) 17 August, 2021

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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) 
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