{"id":4643,"date":"2022-11-30T15:00:25","date_gmt":"2022-11-30T15:00:25","guid":{"rendered":"https:\/\/www.apbiocode.com\/?p=4643"},"modified":"2022-12-27T08:29:33","modified_gmt":"2022-12-27T08:29:33","slug":"%e7%91%9e%e7%a3%81abc-ky-%e9%86%ab%e7%a7%91%e5%b1%95%e4%b8%bb%e6%89%93%e5%85%a8%e9%9d%a2%e7%af%a9%e6%aa%a2%e5%a4%9a%e5%85%83%e6%aa%a2%e6%b8%ac%e6%96%b9%e6%a1%88","status":"publish","type":"post","link":"https:\/\/www.apbiocode.com\/tw\/%e7%91%9e%e7%a3%81abc-ky-%e9%86%ab%e7%a7%91%e5%b1%95%e4%b8%bb%e6%89%93%e5%85%a8%e9%9d%a2%e7%af%a9%e6%aa%a2%e5%a4%9a%e5%85%83%e6%aa%a2%e6%b8%ac%e6%96%b9%e6%a1%88\/","title":{"rendered":"\u745e\u78c1ABC-KY \u91ab\u79d1\u5c55\u4e3b\u6253\u5168\u9762\u7be9\u6aa2+\u591a\u5143\u6aa2\u6e2c\u65b9\u6848"},"content":{"rendered":"<div class=\"container\"><div class=\"row\"><div class=\"col-xxs-12\">\n<h1 class=\"wp-block-heading\"><strong>\u4e09\u5927\u7522\u54c1\u7372<\/strong><strong>TFDA<\/strong><strong>\u4e0a\u5e02\u8a31\u53ef<\/strong> 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Bernard\u9032\u4e00\u6b65\u8868\u793a\uff0c\u570b\u969b\u5927\u5ee0Luminex\u8207BioFire Filmarray\u96d6\u4e5f\u6709\u4f9d\u75c7\u72c0\u5168\u9762\u6aa2\u6e2c\u7684\u985e\u4f3c\u7522\u54c1\uff0c\u4f46Luminex\u5728\u7f8e\u570bFDA 510(k)\u5be9\u67e5\u4e0a\u6709\u90e8\u5206\u7522\u54c1\u88ab\u6a19\u793a\u300cPresumptive\u300d\uff0c\u610f\u6307\u8a72\u9805\u75c5\u539f\u9ad4\u7684\u967d\u6027\u7d50\u679c\uff08Positive Result\uff09\u4ecd\u8981\u900f\u904e\u7b2c\u4e8c\u7a2e\u7d93FDA\u6838\u51c6\u7684\u65b9\u6cd5\u78ba\u8a8d\u5f8c\uff0c\u624d\u80fd\u78ba\u5be6\u5224\u5b9a\u70ba\u967d\u6027\uff0c\u56e0\u6b64\u5927\u5e45\u7e2e\u9650\u5176\u61c9\u7528\u5e02\u5834\u3002BioFire Filmarray\u7684\u7522\u54c1\u5247\u591a\u4f7f\u7528\u5728\u6025\u75c7\u3001\u4ee5\u53ca\u9ad8\u984d\u7684\u81ea\u8cbb\u5e02\u5834\u3002<\/p>\n<p>\u76f8\u8f03\u4e4b\u4e0b\uff0c\u745e\u78c1\u7684\u7522\u54c1\u4e0d\u50c5\u662f\u57fa\u65bc\u9ad8\u901a\u91cf\u5e73\u53f0\u958b\u767c\uff0c\u6191\u85c9\u7368\u5275\u7684BMB\u5e73\u53f0\u6280\u8853\u66f4\u80fd\u964d\u4f4e\u591a\u5143\u6aa2\u6e2c\u7684\u6210\u672c\uff0c\u7784\u6e96\u91cf\u5927\u4e14\u50f9\u683c\u89aa\u6c11\u7684\u6aa2\u6e2c\u5e02\u5834\u3002\u6b64\u5916\uff0c\u745e\u78c1\u7684\u6aa2\u6e2c\u7522\u54c1\u80fd\u63d0\u4f9b\u63a9\u853d\uff08Masking\uff09\u529f\u80fd\uff0c\u53ef\u4ee5\u8b93\u5be6\u9a57\u5ba4\u5f48\u6027\u6311\u9078\u6aa2\u6e2c\u9805\u76ee\u8207\u51fa\u5831\u544a\u7684\u9805\u76ee\uff0c\u7b26\u5408\u4fdd\u96aa\u7d66\u4ed8\u4e0a\u9650\uff0c\u9032\u4e00\u6b65\u4fdd\u969c\u5ba2\u6236\u5229\u6f64\uff0c\u5275\u9020\u5ba2\u6236\u8207\u745e\u78c1\u7684\u96d9\u8d0f\u5c40\u9762\u3002<\/p>\n<p>\u745e\u78c1\u4e26\u8868\u793a\uff0c\u6aa2\u6e2c\u5e73\u53f0\u7684\u5e02\u5834\u50f9\u503c\u53d6\u6c7a\u65bc\u63d0\u4f9b\u6aa2\u6e2c\u9805\u76ee\u6578\u91cf\u7684\u591a\u5be1\u3002\u70ba\u52a0\u901f\u64f4\u5927\u71df\u904b\u91cf\u9ad4\uff0c\u516c\u53f8\u5df2\u898f\u5283\u65bc\u660e\u5e74\u63a8\u51fa\u771f\u83cc\u6aa2\u6e2c\u8207\u6027\u50b3\u67d3\u75c5\u6aa2\u6e2c\u7684\u7814\u7a76\u7528\uff08RUO\uff09\u7522\u54c1\uff0c\u540c\u6642\u8457\u624b\u958b\u767c\u6297\u85e5\u6027\u6aa2\u6e2c\u3001\u6ccc\u5c3f\u9053\u8207\u9670\u9053\u708e\u7b49\u591a\u5143\u5206\u5b50\u6aa2\u6e2c\u9805\u76ee\uff0c\u6a39\u7acb\u9ad8\u901a\u91cf\u591a\u5143\u8a3a\u65b7\u7684\u9818\u5c0e\u54c1\u724c\u3002<\/p>\n 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