Another diagnostic test for the 2009 H1N1 influenza virus received an Emergency Use Authorization by the U.S. Food and Drug Administration on July 24.

The Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third H1N1 diagnostic test to be authorized by the FDA under the Emergency Use Authorization since a public health emergency involving the virus was declared 3 months ago, the agency said in a written statement. The Emergency Use Authorization allows use of unapproved medical products or unapproved uses of approved medical products following a declaration of emergency.

The Focus Diagnostics test is an unapproved device. The authorization ends once the emergency is terminated or when the FDA revokes the authorization.

Focus Diagnostics will be permitted to distribute the test to laboratories certified under the U.S. Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests.

“This authorization will contribute to the nation’s capacity for accurate testing for the 2009 H1N1 influenza virus,” Dr. Daniel G. Schultz, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

Focus Diagnostics is a subsidiary of Quest Diagnostics and is located in Cypress, California.

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7月24日，又有一种针对2009年H1N1流感病毒的诊断试验获得了美国食品药品管理局（FDA）的“紧急使用授权”（Emergency Use Authorization）。

 

FDA在一份书面声明中说，Focus 诊断公司的H1N1流感（2009年）实时逆转录聚合酶链反应（RT-PCR）诊断试验是FDA授权的第三种H1N1流感病毒诊断试验。FDA的这一授权是根据“紧急使用授权”的规定作出的，因为3个月前宣布的突发公共卫生事件与此病毒有关。“紧急使用授权”允许在正式宣布处于紧急状态后使用未经批准的医疗产品，或者虽是已批准上市的医疗产品但用于其未经批准的用途。

 

Focus 诊断公司的这一诊断仪器尚未被批准。一旦紧急状况结束或者FDA撤销授权，授权便终止。

 

Focus 诊断公司将被允许在美国临床实验室促进修正法案（CLIA）认证的各实验室开展这一高度复杂的检验项目。“这一授权将有利于加强检测2009年H1N1流感病毒的准确性”，FDA的仪器与放射健康中心主任Daniel G医生在一份声明中说。

 

Focus 诊断公司是Quest诊断公司的一个子公司，该公司座落于加利福尼亚州的Cypress。

 

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