{"id":22421,"date":"2020-05-20T19:48:47","date_gmt":"2020-05-20T10:48:47","guid":{"rendered":"https:\/\/arita.com\/ar\/?p=22421"},"modified":"2020-05-20T20:10:36","modified_gmt":"2020-05-20T11:10:36","slug":"%e6%96%b0%e5%9e%8b%e3%82%b3%e3%83%ad%e3%83%8a%e6%8a%97%e4%bd%93%e6%a4%9c%e6%9f%bb%e3%81%ab%e6%97%a9%e3%81%8f%e4%bf%9d%e9%99%ba%e9%81%a9%e5%bf%9c%e3%82%92%ef%bc%81","status":"publish","type":"post","link":"https:\/\/arita.com\/ar\/?p=22421","title":{"rendered":"\u65b0\u578b\u30b3\u30ed\u30ca\u6297\u4f53\u691c\u67fb\u306b\u65e9\u304f\u4fdd\u967a\u9069\u7528\u3092\uff01"},"content":{"rendered":"<div 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href=\"https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/eua-authorized-serology-test-performance\">\u7c73\u56fdFDA\uff08\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306f5\u670813\u65e5\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u611f\u67d3\u75c7\u306e\u6297\u4f53\u691c\u67fb\u306b\u3064\u3044\u306611\u793e\u30fb13\u7a2e\u985e\u306e\u8abf\u67fb\u7d50\u679c\u3092\u516c\u8868<\/a>\u3057\u307e\u3057\u305f\u3002\u305d\u306e\u6297\u4f53\u691c\u67fb13\u7a2e\u985e\u306e\u3046\u3061\u3001\u7279\u306b\u7d20\u6674\u3089\u3057\u3044\u7d50\u679c\u3092\u793a\u3057\u305f\u306e\u306f3\u7a2e\u985e\u3002\u8a73\u7d30\u306fFDA\u306e\u5831\u544a\u3092\u8aad\u3093\u3067\u3044\u305f\u3060\u304f\u3068\u3057\u3066\u3001\u7d20\u6674\u3089\u3057\u3044\u306e\u306f\u4e0b\u8a18\u306e\u4f01\u696d\u306e\u88fd\u54c1\u3067\u3059\u3002\u73fe\u5728\u7c73\u56fd\u3067\u306f\u3044\u308d\u3044\u308d\u306a\u691c\u67fb\u304c\u7dca\u6025\u8a8d\u53ef(EUA)\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u7cbe\u5ea6\u306e\u9055\u3044\u304c\u660e\u3089\u304b\u306b\u306a\u3063\u3066\u304f\u308b\u3068\u4eca\u5f8c\u306f\u512a\u308c\u305f\u3082\u306e\u3060\u3051\u306b\u6dd8\u6c70\u3055\u308c\u3066\u3044\u304f\u3082\u306e\u3068\u4e88\u60f3\u3055\u308c\u307e\u3059\u3002<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/eua-authorized-serology-test-performance\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/arita.com\/ar\/wp-content\/uploads\/2020\/05\/200520fda.jpg\" alt=\"\" width=\"700\" height=\"550\" class=\"aligncenter size-full wp-image-22423\" srcset=\"https:\/\/arita.com\/ar\/wp-content\/uploads\/2020\/05\/200520fda.jpg 700w, https:\/\/arita.com\/ar\/wp-content\/uploads\/2020\/05\/200520fda-300x236.jpg 300w\" sizes=\"auto, (max-width: 700px) 100vw, 700px\" \/><\/a><\/p>\n<p>\uff1c\uff11\uff1e\u3000Ortho-Clinical Diagnostics<\/p>\n<p>\u3053\u306e\u4f1a\u793e\u306e2\u7a2e\u985e\u306e\u6297\u4f53\u691c\u67fb\u306e\u3046\u3061\u306e1\u3064\u306f\u3001\u611f\u5ea6100\uff05\u3001\u7279\u7570\u5ea6100\uff05\u3001\u6709\u75c5\u73875\uff05\u306e\u5834\u5408\u306e\u967d\u6027\u7684\u4e2d\u7387100\uff05\u3001\u9670\u6027\u7684\u4e2d\u7387100\uff05\u3068\u3044\u3046\u7d20\u6674\u3089\u3057\u3044\u7d50\u679c\u3067\u3057\u305f\u3002\u3053\u306e\u691c\u67fb\u306fVITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator\u3068\u3044\u3046\u540d\u79f0\u3067\u3001IgG\u6297\u4f53\u30fbIgM\u6297\u4f53\u30fbIgA\u6297\u4f53\u3092\u4e00\u6319\u306b\u6e2c\u5b9a\u3057\u3066\u5224\u65ad\u3059\u308b\u3068\u3044\u3046\u691c\u67fb\u3067\u3059\u3002<a href=\"https:\/\/bio.nikkeibp.co.jp\/atcl\/news\/p1\/20\/05\/10\/06903\/\">\u65e2\u306b4\u670825\u65e5\u306b\u7c73\u56fdFDA\u306e\u7dca\u6025\u8a8d\u53ef(EUA)\u3092\u53d7\u3051\u3066\u7c73\u56fd\u5185\u3067\u767a\u58f2\u3057\u3066\u304a\u308a\u3001\u65e5\u672c\u3067\u306f5\u6708\u4e0b\u65ec\u306e\u767a\u58f2\u3092\u76ee\u6307\u3057\u3066\u3044\u308b<\/a>\u3068\u306e\u3053\u3068\uff08\u3067\u3082\u3001\u7814\u7a76\u7528\u8a66\u85ac\u3068\u3057\u3066\u306e\u767a\u58f2\u3067\u300c\u4fdd\u967a\u9069\u7528\u3068\u3057\u3066\u306e\u8a8d\u53ef\u300d\u306f\u5148\u304b\u3082\u3057\u308c\u307e\u305b\u3093\uff09\u3002<\/p>\n<p>\uff1c\uff12\uff1e\u3000Roche<\/p>\n<p>\u3053\u306e\u793e\u306e\u6297\u4f53\u691c\u67fb\u306fIgG\u6297\u4f53\u3068IgM\u6297\u4f53\u3092\u6e2c\u5b9a\u3057\u3001\u611f\u5ea6100\uff05\u3001\u7279\u7570\u5ea699.8\uff05\u3001\u6709\u75c5\u73875\uff05\u306e\u5834\u5408\u306e\u967d\u6027\u7684\u4e2d\u738796.5\uff05\u3001\u9670\u6027\u7684\u4e2d\u7387100\uff05\u3068\u306e\u3053\u3068\u3002\u5148\u65e5\u8a18\u3057\u305f\u3088\u3046\u306b\u3001\u4f1a\u793e\u30c8\u30c3\u30d7\u304c\u300c\u4ed6\u306e\u88fd\u54c1\u306f\u4f7f\u3044\u7269\u306b\u306a\u3089\u306a\u3044\u300d\u3068\u81ea\u8ca0\u3057\u3066\u3044\u305f\u306e\u306f\u591a\u5206\u306b\u5ba3\u4f1d\u8fbc\u307f\u3067\u3059\u304c\u3001Roche\u793e\u306e\u6297\u4f53\u691c\u67fb\u304c\u512a\u79c0\u306a\u306e\u306f\u9593\u9055\u3044\u306a\u3055\u305d\u3046\u3067\u3059\u3002\u3061\u306a\u307f\u306b\u3001Roche\u793e\u306f\u65e5\u672c\u30675\u670813\u65e5\u304b\u3089\u7814\u7a76\u7528\u8a66\u85ac\u3068\u3057\u3066\u306e\u8ca9\u58f2\u3092\u958b\u59cb\u3057\u3001<a href=\"https:\/\/www.nikkei.com\/article\/DGKKZO59012880S0A510C2TJ2000\/\">5\u6708\u4e2d\u306b\u539a\u751f\u52b4\u50cd\u7701\u3078\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u3092\u7533\u8acb\u3057\u3066\u4fdd\u967a\u9069\u7528\u3092\u76ee\u6307\u3059<\/a>\u3068\u306e\u3053\u3068\u3067\u3059\u3002<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/arita.com\/ar\/wp-content\/uploads\/2020\/05\/200520roch.jpg\" alt=\"\" width=\"700\" height=\"295\" class=\"aligncenter size-full wp-image-22424\" srcset=\"https:\/\/arita.com\/ar\/wp-content\/uploads\/2020\/05\/200520roch.jpg 700w, https:\/\/arita.com\/ar\/wp-content\/uploads\/2020\/05\/200520roch-300x126.jpg 300w\" sizes=\"auto, (max-width: 700px) 100vw, 700px\" \/><\/p>\n<p>\uff1c\uff13\uff1e\u3000Abbott<\/p>\n<p>\u3053\u306e\u793e\u306e2\u7a2e\u985e\u306e\u6297\u4f53\u691c\u67fb\u306e\u3046\u3061\u306e1\u3064\u3001Architect SARS-CoV-2 IgG\u306f\u3001\u611f\u5ea6100\uff05\u3001\u7279\u7570\u5ea699.6\uff05\u3001\u6709\u75c5\u73875\uff05\u306e\u5834\u5408\u306e\u967d\u6027\u7684\u4e2d\u738792.9\uff05\u3001\u9670\u6027\u7684\u4e2d\u7387100\uff05\u3002<a 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