雅培的雅培炎病丙型肝炎病毒检测技术成功地通过FDA审批

2011-05-19 15:47 · pobee

摘要： 近日， Abbott to

摘要：近日，丙毒检内科医生可以检测出极微量的型肝病毒由于检验病毒药物是否有效。鉴于其灵敏性，测技这一技术在2000个样本中检测丙型肝炎病毒，术成A审这一技术是功地基于实时定量PCR研制而成。雅培公司证实食品药品管理局（FDA）已经核查并批准该公司丙型肝炎病毒检测技术，通过

Abbott today announced the US Food and 雅培炎病Drug Administration has approved its RealTime PCR-based test for hepatitis C.

The test, which runs on the Abbott m2000 platform, measures HCV in human plasma or serum. According to Abbott, it is the only test for which the limit of detection and limit of quantitation are the same, 12 IU/mL. At this level of sensitivity, physicians can measure very low levels of the virus in order to determine whether antiviral drug treatments are working, the company added.

In a statement, Joseph Jacobs, associate medical director for Abbott, said that the addition of the HCV assay to the m2000 system makes Abbott the only molecular diagnostic company in the US offering viral load assays for HIV, HBV, and HCV, and a combination test for chlamydia and gonorrhea on one platform.

"This enables laboratories to consolidate sexually transmitted and infectious disease testing to improve workflow and productivity," Jacobs said. "Also, having a single manufacturer of these tests provides the clinician with a level of assurance of consistency and quality when managing patients."

The RealTime HCV assay is used to help manage HCV-infected patients undergoing antiviral therapy. It measures HCV RNA levels at baseline and during treatment, and can be used to predict sustained and non-sustained virological response to HCV therapy, Abbott said.

Test results must be interpreted "within the context of all relevant clinical and laboratory findings," it said, adding the test is not for screening blood, plasma, serum, or tissue donors for HCV. It also is not for use as a diagnostic for the presence of the virus.

In addition to Abbott, several other firms are developing a molecular diagnostic test for HCV, and last fall Roche received FDA clearance for its second-generation real-time PCR Cobas TaqMan HCV test. Siemens Healthcare received FDA clearance for an HCV monitoring test in 2008.

Also in the fall, Abbott and Qiagen entered into a broad-based molecular diagnostics agreement , and as part of the deal, Abbott is providing a quantitative HCV test, to be optimized and labeled for use on Qiagen's QIAsymphony RGQ instrument. The test, which is anticipated to launch at the end of 2012, will be marketed under the Abbott name in the US and Canada.

鉴于其灵敏性，丙毒检这一技术在2000个样本中检测丙型肝炎病毒，型肝这一技术是测技基于实时定量PCR研制而成。内科医 生可以检测出极微量的术成A审病毒由于检验病毒药物是否有效。雅培公司证实食品药品管理局（FDA）已经核查并批准该公司丙型肝炎病毒检测技术，功地