SCIEX Topaz临床液质联用系统

  SCIEX Diagnostics是SCIEX的体外诊断部门，宣布推出首款完全集成的LC-MS临床诊断系统SCIEX Topaz™。Topaz系统专为满足临床诊断实验室的独特需求而设计，降低了采用LC-MS的障碍，使整个临床实验室工作人员可以使用它。该系统的核心在于创新的ClearCore™MD软件，这是一个简化工作流程和方法开发的平台，并结合了增强可用性的功能，以帮助新用户快速增加熟练程度。

　　此外，第一个通过LC-MS的维生素D测定试剂盒（通过从头途径）通过SCIEX维生素D 200M测定法，用于SCIEX Topaz系统。据美国CDC，LC-MS技术是测试维生素D的金标准方法，因为它提供了比免疫测定方法更高的特异性和更少的交叉反应性。维生素D 200M测定试剂盒已经成功地满足了CDC维生素D标准化认证计划（VDSCP）制定的严格的性能标准。该测定分别定量维生素D2和D3，同时分离出D3差向异构体，提供了精确测量维生素D状态的能力。

　　Topaz系统提供了zei终的灵活性，既有用于实验室开发测试（LDT）的开放系统和用于运行锁定，预先验证的测定的封闭系统，另外，FDA批准的维生素D解决方案可立即实施，因此实验室工作人员可以快速启动和运行。Topaz系统使临床实验室能够快速扩展其测试服务，并在内部实现以前的外包测试，在更少的时间内，以较少的复杂性实现更低的成本节省，从而有利于提供优质的患者护理。

　　SCIEX Topaz系统通过使这种强大的技术可供所有用户使用，降低了对临床诊断实验室采用LC-MS的障碍

　　“SCIEX的目标是为临床实验室简单地进行质谱分析，其结果是第一个基于LC-MS的集成式IVD系统，其设计开放并在需要时关闭。” SCIEX诊断总监兼总经理Aaron Hudson博士说，“创新的ClearCore MD软件可简化工作流程和方法开发，将SCIEX LC-MS技术的功能带入常规用户手中。结合第一次通过FDA批准的（通过de novopathway）维生素D LC-MS测定，Topaz系统使实验室能够做更多的工作，节省更多，并提供更自信的结果来支持临床医生。

　　Emory大学医学院病理与实验室医学教授Jim Ritchie博士说：“SCIEX Diagnostics的Topaz系统是中型临床实验室一直在等待的LC-MS。我相信这个系统在很多方面正接近化学分析仪的自动化阶段。在我们的临床实验室中轻松培训医学技术，轻松学习操作，采用和维持。我们相信，为了方便使用而设定了新的标准。”

　　Topaz系统的推出进一步扩大了丹纳赫公司提供的临床诊断解决方案，其中包括Beckman Coulter，Cepheid，Leica Biosystems，Radiometer和SCIEX Diagnostics。该组合的广度从临床和解剖病理实验室的新型诊断技术到护理点测试。丹纳赫的诊断公司凭借丰富的创新历史和创新传统，致力于开发新的独特诊断方法，以改善优质的病人护理，并帮助医疗系统建立全面高效的诊断服务，具有高度的自动化程度，通过标准化和数据连接的准确性。

SCIEX launches the Topaz™ LC-MS/MS System for Clinical Diagnostics in Europe

A fully-integrated CE-marked and FDA Class I medical device demonstrating both open design and capability for locked methods, will be showcased at MSACL EU 2017

September 08, 2017

WARRINGTON UK — SCIEX Diagnostics, the in vitro diagnostics division of SCIEX, a global leader in life science industry, will be showcasing the SCIEX Topaz™ System for Clinical Diagnostics at the 4th Annual European Congress & Exhibition of the Association for Mass Spectrometry: Application to the Clinical Lab (MSACL EU 2017) in Salzburg, Austria on September 10-14. This fully integrated LC-MS/MS system for clinical diagnostics will be showcased in the SCIEX booth (#12-13) and live software demonstrations will be offered throughout the exhibition. The Topaz System is designed specifically to meet the unique needs of the clinical diagnostic lab, lowering the barriers to adoption of LC-MS/MS and making it accessible to the entire clinical lab staff.

The Topaz System offers unique flexibility; with both an open system designed for lab-developed tests (LDTs) and for the capability for running locked, SCIEX pre-developed assays kits. The easy-to-use Topaz System enables clinical labs to expand their testing services and bring previously outsourced tests in-house, providing opportunities for cost savings along with gold-standard accuracy, in less time, with less complexity - all for the benefit of supporting quality patient care. The system’s innovative ClearCore™ MD software simplifies and streamlines workflows and method development, and incorporates features that enhance usability to help new users build proficiency quickly.

“SCIEX set out with the goal of making mass spectrometry simple for clinical labs, and the outcome is the integrated LC-MS-based IVD system that is open by design and closed when you need it,” said Dr. Aaron Hudson, Sr. Director and GM of SCIEX Diagnostics. “The innovative ClearCore MD software simplifies and streamlines workflows and method development, bringing the power of SCIEX LC-MS technology to the hands of the routine user.”

During the exhibition, SCIEX will present a seminar entitled “Introducing the new SCIEX Topaz™ System, a CE-marked integrated LC-MS IVD system” for those interested in hearing more about this unique system. The seminar will be presented on Wednesday 13th September, 14:00 - 14:30, in the Papageno Room at the Salzburg Congress Centre. Attendance to the seminar is open to all MSACL EU 2017 delegates, including press. There will also be a poster presented on this topic during the poster session of the conference. For more information on the Topaz system or SCIEX´s other leading analytical technologies and solutions, please contact Carmen.Boxheimer@sciex.com to arrange a meeting at MSACL EU 2017, or visit SCIEX at booth #12-13 during the show or visit https://sciex.com/events/msacl-eu-2017.