Molecular Designs 流感与呼吸道合胞病毒联检面板11月13日获食品药品管理局510(k)许可：编号 K262789
美国阿拉巴马州 Birmingham，Molecular Designs 于11月13日宣布，美国食品药品管理局已授予其 SimplicityDx Panel FluA/FluB/RSV 检测面板 510(k) 许可，编号 K262789，这是该公司首个获得食品药品管理局许可的检测产品。
该面板为多重实时逆转录聚合酶链式反应检测，用于对有呼吸道感染症状与体征的患者前鼻拭子样本中的甲型流感病毒、乙型流感病毒与呼吸道合胞病毒核糖核酸进行定性检测与区分。面板包含内对照，设计上与该公司的 Simplicity Dx Extraction 提取产品配合使用。
公司表示，该面板采用可拆分形式，实验室可只运行所需的检测数量，移液步骤少，并支持批量处理，在呼吸道检测量波动时可减少试剂浪费与库存压力。
这一许可仅限处方使用，并限于通过临床实验室改进修正案认证的高复杂度实验室。此次发布未提供临床性能数据表、出结果时间、价格或商业上市日期。
图中是甲型流感病毒的透射电子显微镜图像
Molecular Designs Wins FDA 510(k) Clearance K262789 on November 13 for Its SimplicityDx Flu A, Flu B and RSV Panel
Birmingham, Alabama, United States. Molecular Designs said on November 13 that the U.S. Food and Drug Administration has granted 510(k) clearance, K262789, for its SimplicityDx Panel FluA/FluB/RSV, the company's first FDA-cleared assay.
The multiplex real-time RT-PCR test is designed to qualitatively detect and distinguish influenza A, influenza B and respiratory syncytial virus RNA from anterior nasal swabs collected from patients with signs and symptoms of respiratory infection. The panel includes an internal control and is intended to work with the company's Simplicity Dx Extraction products.
The company said the panel uses a breakaway format so laboratories can run only the number of tests needed, with minimal pipetting and support for batch processing, an approach it said may reduce reagent waste and inventory pressure when respiratory testing volumes fluctuate.
The clearance is limited to prescription use in CLIA-certified high-complexity laboratories. The release did not provide clinical performance tables, turnaround time, pricing or a commercial launch date.
来源：Molecular Designs
发布：GSM·美国（发布链接）
图片来源：图：甲型流感病毒的透射电子显微镜图像。来源：美国疾病控制与预防中心／Erskine Palmer博士，公共领域，维基共享资源。 / Photo: Transmission electron micrograph of influenza A virus. Credit: CDC / Dr. Erskine Palmer, public domain, via Wikimedia Commons.
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