聖湘生物(688289.SH):全資子公司相關檢測產品獲得歐盟CE List A認證
格隆匯5月24日丨聖湘生物(688289.SH)公佈,公司全資子公司湖南聖維基因科技有限公司的產品乙型肝炎病毒、丙型肝炎病毒、人類免疫缺陷病毒(1+2型)核酸檢測試劑盒(PCR-熒光法)於近日獲得歐盟CE認證(IVDD List A類)。該試劑盒可用於血源篩查,一管檢測可區分乙肝、丙肝和艾滋病毒,通過高精度和自動化方案,助力全球用血安全和院感防控。這是繼乙肝、丙肝和艾滋三款核酸檢測產品後,公司及全資子公司獲得的第四個歐盟CE List A類認證,在歐盟CE認證的類別中,List A類產品受法規監管程度最高,技術要求嚴格,其所需進行的驗證、評估和審核強度較高,認證難度較大,獲得此項認證充分體現了公司的研發創新實力、產品質量與可靠性能。
該產品主要運用磁珠法核酸提取技術,結合實時熒光PCR擴增技術,可用於定性檢測血漿或血清樣本中的HBVDNA、HCVRNA、HIV-1RNA和HIV-2RNA病毒,通過高精度和自動化方案,準確和高效地進行病毒檢測。在佈局血液篩查的同時,公司積極進行了多中心臨牀研究,將血篩應用於術前傳染病篩查,發揮核酸檢測靈敏度高、特異強等優勢,進一步助力用血安全和院感防控。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.