2019冠状病毒疾病临床Testing & Labs

访问重要的技术和跨功能体验,以满足您的COVID-19测试需求。作为世界领先的临床研究中心实验室网络,科文斯中心实验室提供全球一致、可操作的数据,以推动COVID-19研究的向前发展——更快。

Connect with our COVID-19 response team

支持您的COVID-19的分析和生物标记物需求

Extract the most value out of our globally integrated central laboratory network with the help of our scientific and operational experts. With deep experience gained from more than 4,400 clinical trials during the past five years across all therapeutic areas, we know how to optimize your studies and mitigate potential issues to meet the fast-pace associated with coronavirus (COVID-19) studies.

分子分析

  • RT-qPCR分析
  • 测序分析
  • 专业分析

免疫化学

  • COVID-19感染的血清学检测
  • Immunoassays – inflammatory and immunologic response

Cell-Based and Micro Assays

  • Viral culture
  • Neutralizing antibody assays
  • BSL3 capabilities

COVID-19分析可用性

COVID-19的几种分析正在进行加速验证,以满足试验测试标准。

病毒载量(qPCR)

  • 建立在Labcorp紧急使用授权Diagnostic, which was made available in early March
  • Now available for clinical trials

病毒中和试验

  • Expected availability for clinical trials in early Q3 of 2020

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2019冠状病毒疾病筛选/Rapid Detection by PCR

  • Validation will begin immediately following FDA approval of the GeneXpert® assay from Cepheid
  • 试剂盒可用后3周临床试验的预期可用性

Antibody Detection by ELISA

  • 已启动IgG和IgA的验证;预计2020年6月临床试验可用性
  • Additional evaluations of IgM and quantitative serology tests will begin immediately upon availability of kits and reagents and be completed within 6-8 weeks

排除分析

可用于排除其他呼吸疾病的分析面板已经验证,以满足临床试验测试标准。

  • BioFire®FilmArray®呼吸小组排除了21different respiratory illnesses. BioFire Diagnostics is adding COVID-19 to the panel; expanded panel expected to be available for clinical trials 3-4 weeks following reagent kit availability.

传染病& Vaccine Lab Testing Experience

每年,我们都会产生5500多万报告的结果(资料来源:Covance CLA内部度量2018)

传染病

疫苗


加速研究设置

To speed up study startups, we've created a the Streamlined Study Start-Up (SSSU) team to help liaise with key departments to shorten timelines. We've seen unprecented speeds, including a 5-business-day turnaround.

Discover how technology innovation expedites your study startup.


生物分析法

  • 阿巴卡韦/达芦那韦/特拉韦林
    /拉米夫定/奈韦拉平/
    萨奎纳维/斯塔夫定/齐多夫定
    –组合方法
  • Amprenavir
  • Amprenavir/Ritonavir – combo method
  • Atazanavir/Ritonavir – combo method
  • Azithromycin
  • Emtricitabine
  • Emtricitabine/Tenofovir – combo method
  • 洛皮那韦/利托那韦-组合法
  • Maraviroc
  • 雷特格韦
  • Ribavirin
  • Rilpivirine
  • 利托那韦
  • 泰诺福韦

批准用于COVID-19试验的专有方法:
Hydroxychloroquine

CMC Analytical

  • 分析control strategy and plan to align with product CQAs
  • 方法开发、阶段适当资格和验证(GMP/ICH)
  • Potency assays and formulation development
  • 分析testing (including in-process): safety, identity, strength, quality and purity
  • Routine global lot release and stability testing under commercial GMP conditions

    Available for clinical trials

    • 病毒载量(qPCR)

      建立在Labcorp紧急使用授权Diagnostics, which was made available in early March 2020

      2020年4月临床试验预期可用性

    疫苗类型

    • 衰减活
    • Inactivated
    • 病毒载体
    • 类病毒颗粒
    • Protein subunit
    • Loaded nanoparticles
    • Polysaccharide subunit
    • DNA
    • 信使核糖核酸
    • Polyvalent
    • 合成的
    • Liposomes

    相关实验室内容

    吉涅xpert® 是造父的商标

    BioFire® FilmArray® is a trademark of BioFire Diagnostics LLC

    与我们的COVID-19响应团队联系

    Contact Us