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FDA批准罗氏CMV检测 FDA Approves Roche's CMV Test

文章来源:网络发布日期:2017-06-24浏览次数:185

近日,罗氏宣布其公司用于Cobas 6800/8800分子诊断仪的Cobas巨细胞病毒检测已通过美国FDA批准。 Cobas巨细胞病毒检测基于实时PCR技术,用于评估移植患者对治疗的反应。 罗氏公司表示,该公司的扩展线性范围从34.5 IU / mL到1E + 07 IU / mL,具有较强的跨基因型覆盖率,并补充说,该测试可大限度地减少变异性和复杂性测试,从而降低实验室开发测试中实验室的工作量和风险。 罗氏说,Cobas CMV检测可以同时在Cobas 6800/8800系统上进行HIV-1和HCV检测。 它也被标准化为世界卫生组织国际标准,用于改善医院机构CMV测试结果的协调统一。 罗氏诊断公司负责人Uwe Oberlaender在一份声明中表示,通过第二代测试,“临床医生现在可以跨机构获得更快,更可靠,标准化的结果,这是优化CMV管理移植决策所必要且重要的一步骤。”

ROCHE
Roche today announced the US Food and Drug Administration has approved the company's Cobas cytomegalovirus test for use on the fully automated Cobas 6800 and 8800 systems.
The real-time PCR-ba[x]sed Cobas CMV test is for assessing how transplant patients on therapy respond to treatment. It offers an expanded linear rage from 34.5 IU/mL to 1E+07 IU/mL with robust coverage across genotypes, Roche said, adding that the test minimizes variability and complexity testing, reducing workload and risk for laboratories offering laboratory-developed tests.
The Cobas CMV test can be simultaneously run with HIV-1 and HCV assays on the Cobas 6800/8800 systems, Roche said. It also is standardized to the First World Health Organization International Standard for improving harmonization in CMV testing results across hospital institutions.
Uwe Oberlaender, head of Roche Diagnostics, said in a statement that with the second-generation test, "clinicians can now receive faster, more reliable, standardized results aligned across institutions. This is a required and important step toward optimizing CMV management decisions for transplant patients."