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BD Veritor系統獲得FDA批準

BD2011年12月26日 14:38 點擊:2821

美國BD Becton, Dickinson 美國食品藥品監督管理局(FDA,U.S. Food and Drug Administration)


BD公司的BD Veritor系統獲得FDA批準。BD公司稱,該系統可以在10分鐘內快速診斷甲型和乙型流感,并且比現有的流感快速測試方法更準確和易于讀取結果。

New BD Veritor™ System for Rapid Detection of Flu A+B Receives 510(k) Clearance and CLIA Waiver
 


New Influenza Test Receives FDA CLIA Waiver Offers Users Strong Performance, Coupled with Easy-to-Read Results

 

Franklin Lakes, NJ (December 19, 2011) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today that it received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the BD Veritor™ System for rapid detection of Flu A+B.  This is the first rapid influenza test system that incorporates a digital read out of results to receive CLIA waiver.

The BD Veritor System delivers very good analytical sensitivity and specificity, offering healthcare professionals a new and different option in rapid influenza testing versus current visually read CLIA-waived assays.  The BD Veritor System provides objective results on an easy to read digital display, unlike current CLIA-waived rapid influenza tests, which require a subjective visual test interpretation to determine a positive or a negative test result.

“The new BD Veritor System provides a new approach for CLIA-waived rapid tests for influenza A+B by offering a combination of speed, accuracy and convenience with an objective read that physicians can trust,” said Tom Polen, President, BD Diagnostics – Diagnostic Systems.  “We believe the BD Veritor System has the potential to change the way doctors view in-office rapid flu testing.”

The BD Veritor System rapid flu immunoassay reports performance measured against polymerase chain reaction (PCR) results, the highest sensitivity standard currently available.  This newly designed system incorporates BD’s novel Nano Detection Particle and Adaptive Read Technology.  With this unique combination of technologies in a CLIA-waived Flu assay, the BD Veritor System offers users:

  • A convenient workflow
  • Few, easy steps requiring very little sample preparation
  • No sample incubation required prior to running the test
  • Ten-minute period for the test to run and ten seconds of instrument read for final results.

The assay for rapid detection of Flu A+B on the BD Veritor System represents the first of many different assays that are planned on this new platform.

For more information on the BD Veritor System, please visit http://www.bd.com/ds/veritorsystem.

About BD

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.

Contact: Alyssa Zeff
BD Public Relations
(201) 847-4358
Email: [email protected]

(來源: BD )


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