{"id":1790,"date":"2020-03-25T09:04:16","date_gmt":"2020-03-25T00:04:16","guid":{"rendered":"https:\/\/clarivate.com\/jp\/blog\/covid-19-testing-%e6%9c%80%e6%96%b0%e3%81%aefda%e3%82%ac%e3%82%a4%e3%83%80%e3%83%b3%e3%82%b9%e6%9b%b4%e6%96%b0%e3%81%ab%e9%96%a2%e3%81%97%e3%81%a6\/?lang=ja"},"modified":"2020-03-25T09:04:16","modified_gmt":"2020-03-25T00:04:16","slug":"covid-19-testing-fda-guidance-update-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/covid-19-testing-fda-guidance-update-2\/","title":{"rendered":"COVID-19 testing: \u6700\u65b0\u306eFDA\u30ac\u30a4\u30c0\u30f3\u30b9\u66f4\u65b0\u306b\u95a2\u3057\u3066"},"content":{"rendered":"<p><strong>JAIME POLYCHRONES<\/strong><br \/>\nMedical Writer, Cortellis Regulatory Intelligence<br \/>\nClarivate<br \/>\n&nbsp;<\/p>\n<p><a href=\"https:\/\/clarivate.com\/cortellis\/article\/covid-19-testing-fda-guidance-update\/\">\u82f1\u8a9e\u539f\u6587<\/a><\/p>\n<p style=\"text-align: right\">2020\u5e743\u670811\u65e5<\/p>\n<p>SARS-CoV2\u304c\u5e83\u304c\u308a\u7d9a\u3051\u3001\u305d\u306e\u7d50\u679c\u3068\u3057\u3066Coronavirus Disease 2019\uff08COVID-19\uff09\u306e\u7f79\u60a3\u8005\u304c\u767a\u751f\u3057\u3066\u3044\u307e\u3059\u3002\u79c1\u9054\u306f\u533b\u7642\u73fe\u5834\u306b\u304a\u3051\u308bIVD\u30c6\u30b9\u30c8\u3068\u30ec\u30b9\u30d4\u30ec\u30fc\u30bf\u30fc\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308bFDA\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u8abf\u67fb\u3057\u3001\u73fe\u5728\u306e\u6cbb\u7642\u3068\u30ef\u30af\u30c1\u30f3\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u306b\u7126\u70b9\u3092\u5f53\u3066\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u4e2d\u56fd\u306e\u6e56\u5317\u7701\u6b66\u6f22\u5e02\u3067\u6700\u521d\u306b\u691c\u51fa\u3055\u308c\u305f\u65b0\u3057\u3044\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306f\u3001\u73fe\u5728\u3001\u7c73\u56fd\u3092\u542b\u3080\u4e16\u754c\u306e50\u4ee5\u4e0a\u306e\u5834\u6240\u3067\u691c\u51fa\u3055\u308c\u3066\u304a\u308a\u3001\u6bce\u65e5\u591a\u304f\u306e\u75c7\u4f8b\u304c\u767a\u8868\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30a6\u30a4\u30eb\u30b9\u306fSARS-CoV2\u3068\u547c\u3070\u308c\u3001\u60a3\u8005\u306b\u751f\u3058\u308b\u75be\u60a3\u306fCoronavirus Disease 2019\uff08COVID-19\uff09\u3068\u547c\u3070\u308c\u307e\u3059\u3002FDA\u306b\u3088\u308b\u3068\u3001\u30a6\u30a4\u30eb\u30b9\u306e\u6025\u901f\u306a\u62e1\u6563\u80fd\u529b\u3092\u8003\u3048\u308b\u3068\u3001\u7c73\u56fd\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u3068\u793e\u4f1a\u5168\u4f53\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3068\u3044\u3046\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff08WHO\uff09\u306f\u3001\u3053\u306e\u7f79\u60a3\u8005\u306e\u3046\u3061\u7d042%\u304c\u6b7b\u4ea1\u3057\u305f\u3068\u5831\u544a\u3057\u3066\u3044\u307e\u3059\u3002SARS-CoV2\u306e\u666e\u53ca\u306b\u5bfe\u51e6\u3059\u308b\u73fe\u5728\u306e\u53d6\u308a\u7d44\u307f\u306b\u306f\u3001IVD\u30c6\u30b9\u30c8\u306e\u958b\u767a\u3001\u611f\u67d3\u60a3\u8005\u3092\u6cbb\u7642\u306e\u305f\u3081\u306e\u7279\u5b9a\u30ec\u30b9\u30d4\u30ec\u30fc\u30bf\u30fc\u306e\u4f7f\u7528\u8a31\u53ef\u3001COVID-19\u306e\u6cbb\u7642\u3068\u30ef\u30af\u30c1\u30f3\u306e\u958b\u767a\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u7c73\u56fd\u3067\u306e\u8fc5\u901f\u8a3a\u65ad\u30c6\u30b9\u30c8\u306e\u5fc5\u8981\u6027<\/strong><\/h3>\n<p>2020\u5e742\u670829\u65e5\u306b\u3001FDA\u306f\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306e\u8a3a\u65ad\u30c6\u30b9\u30c8\u3092\u958b\u767a\u3059\u308b\u7279\u5b9a\u306e\u7814\u7a76\u6240\u5411\u3051\u306e\u65b0\u3057\u3044\u30dd\u30ea\u30b7\u30fc\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u30dd\u30ea\u30b7\u30fc\u306f\u3001\u7c73\u56fd\u304c\u3088\u308a\u8fc5\u901f\u306a\u8a3a\u65ad\u80fd\u529b\u306e\u9054\u6210\u3092\u652f\u63f4\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u3001\u7dca\u6025\u516c\u958b\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u5f62\u3067\u63d0\u4f9b\u3055\u308c\u307e\u3057\u305f\u3002\u653f\u5e9c\u6a5f\u95a2\u306f\u3001\u7dca\u6025\u6642\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u306e\u767a\u884c\u57fa\u6e96\u3092\u5909\u66f4\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u3001\u304a\u3088\u3073\u3053\u306e\u884c\u52d5\u304c\u516c\u8846\u885b\u751f\u306b\u5bfe\u3059\u308b\u91cd\u8981\u306a\u5065\u5eb7\u30cb\u30fc\u30ba\u3078\u306e\u53d6\u308a\u7d44\u307f\u3092\u5f37\u8abf\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u5f37\u8abf\u3057\u307e\u3057\u305f\u3002FDA\u304c\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u8a3a\u65ad\u304a\u3088\u3073\u6cbb\u7642\u7528\u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306b\u767a\u884c\u3057\u305f\u76f4\u8fd1\u306eEUA\u306f\u30012016\u5e74\u306b\u30b8\u30ab\u30a6\u30a4\u30eb\u30b9\u306b\u5bfe\u5fdc\u3057\u305f\u3082\u306e\u3067\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19\u306e\u767a\u751f\u306b\u5bfe\u3057\u3066\u8fc5\u901f\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u611f\u67d3\u4e8b\u4f8b\u3092\u901f\u3084\u304b\u306b\u691c\u51fa\u3057\u3001\u611f\u67d3\u8005\u3068\u63a5\u89e6\u3057\u305f\u4eba\u7269\u3092\u7279\u5b9a\u3057\u3001\u81e8\u5e8a\u30b1\u30a2\u3068\u611f\u67d3\u3092\u9069\u5207\u306b\u7ba1\u7406\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002FDA\u306f\u3001\u516c\u7684\u533b\u7642\u73fe\u5834\u3001\u8907\u6570\u7a2e\u306e\u691c\u67fb\u5ba4\u3001\u304a\u3088\u3073\u6cbb\u7642\u306e\u73fe\u5834\u3067\u3001\u8a3a\u65ad\u6a5f\u80fd\u3092\u5e83\u304f\u5229\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u8ff0\u3079\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u73fe\u5728\u3001\u691c\u8a3c\u6e08\u307f\u306eCOVID-19\u8a3a\u65ad\u85ac\u3092\u958b\u767a\u304a\u3088\u3073\u4f7f\u7528\u3057\u3066\u3044\u308b\u4e00\u90e8\u306e\u7814\u7a76\u6240\u306f\u3001\u6a5f\u95a2\u304cEUA\u30ea\u30af\u30a8\u30b9\u30c8\u306e\u30ec\u30d3\u30e5\u30fc\u3092\u5b8c\u4e86\u3059\u308b\u524d\u304b\u3089\u305d\u306e\u3088\u3046\u306b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306eEUA\u306f\u3001\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u307e\u305f\u306f\u3001\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u3068\u306a\u308b\u53ef\u80fd\u6027\u306e\u5897\u52a0\u306b\u95a2\u3059\u308b\u6c7a\u5b9a\u304c\u3042\u308b\u5834\u5408\u306b\u3001\u75be\u60a3\u307e\u305f\u306f\u72b6\u614b\u3092\u8a3a\u65ad\u3001\u6cbb\u7642\u3001\u307e\u305f\u306f\u4e88\u9632\u3059\u308b\u306e\u306b\u6709\u52b9\u306a\u7279\u5b9a\u306e\u533b\u85ac\u54c1\u306e\u79d1\u5b66\u7684\u30c7\u30fc\u30bf\u306e\u30ec\u30d3\u30e5\u30fc\u306b\u57fa\u3065\u3044\u3066\u7c73\u56fd\u4fdd\u5065\u798f\u7949\u7701\uff08HHS\uff09\u306b\u3088\u308a\u767a\u884c\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>\u3053\u306e\u6c7a\u5b9a\u306f\u30012020\u5e742\u67084\u65e5\u306bHHS\u9577\u5b98\u306b\u3088\u308a\u3001COVID-19\u306e\u767a\u751f\u3092\u691c\u51fa\u304a\u3088\u3073\/\u307e\u305f\u306f\u8a3a\u65ad\u3059\u308b\u305f\u3081\u306e\u4f53\u5916\u8a3a\u65ad\u85ac\uff08IVD\uff09\u306e\u7dca\u6025\u4f7f\u7528\u3092\u8a31\u53ef\u3059\u308b\u305f\u3081\u306b\u884c\u308f\u308c\u307e\u3057\u305f\u3002FDA\u306f\u3053\u308c\u307e\u3067\u306e\u3068\u3053\u308d\u3001\u75be\u75c5\u7ba1\u7406\u4e88\u9632\u30bb\u30f3\u30bf\u30fc\uff08CDC\uff09\u304a\u3088\u3073\u5168\u7c73\u306e\u3044\u304f\u3064\u304b\u306e\u516c\u8846\u885b\u751f\u7814\u7a76\u6240\u306bEUA\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>COVID-19\u4f53\u5916\u8a3a\u65ad\u691c\u67fb\u30ac\u30a4\u30c0\u30f3\u30b9<\/strong><\/h3>\n<p>2020\u5e742\u670829\u65e5\u306b\u3001FDA\u306f\u3001\u300cImmediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency, 29-February-2020\u300d\u3092\u3001\u76f4\u3061\u306b\u30c6\u30b9\u30c8\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u305f\u3081\u3001\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u3092\u8981\u6c42\u3057\u306a\u3044\u5f62\u3067\u516c\u958b\u3057\u307e\u3057\u305f\u3002FDA\u306f\u73fe\u5728\u3001\u96fb\u5b50\u63d0\u51fa\u304a\u3088\u3073\u90f5\u9001\u306b\u3088\u3063\u3066\u30ac\u30a4\u30c0\u30f3\u30b9\u516c\u958b\u5f8c\u306e\u30b3\u30e1\u30f3\u30c8\uff08Docket\u756a\u53f7FDA-2020-D-0987\uff09\u3092\u52df\u96c6\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>\u3053\u306e\u3088\u3046\u306a\u5236\u9650\u3092\u7de9\u548c\u3057\u305f\u30b9\u30c6\u30c3\u30d7\u306f\u3001\u958b\u767a\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3057\u3001\u30c6\u30b9\u30c8\u30b5\u30a4\u30c8\u3067\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u9ad8\u901f\u5316\u3059\u308b\u3068\u540c\u6642\u306b\u3001\u4ed6\u306e\u30d7\u30e9\u30a4\u30d9\u30fc\u30c8\u30c6\u30b9\u30c8\u958b\u767a\u306b\u3082\u30a4\u30f3\u30bb\u30f3\u30c6\u30a3\u30d6\u3092\u63d0\u4f9b\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/strong><\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>FDA\u306f\u3001\u81e8\u5e8a\u691c\u67fb\u306e\u305f\u3081\u306b\u3053\u308c\u3089\u306e\u691c\u67fb\u85ac\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u306b\u53cd\u5bfe\u3057\u306a\u3044\u3068\u8ff0\u3079\u307e\u3057\u305f\u304c\u3001\u691c\u67fb\u5ba4\u306f\u5f53\u5c40\u3068\u3068\u3082\u306bEUA\u3092\u5b9f\u884c\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30dd\u30ea\u30b7\u30fc\u306f\u3001Clinical Laboratory Improvement Amendments\uff08CLIA\uff09\u306e\u8981\u4ef6[42CFR493]\u3068\u4e00\u81f4\u3059\u308b\u8907\u96d1\u5ea6\u306e\u9ad8\u3044\u30c6\u30b9\u30c8\u306e\u5b9f\u884c\u304c\u8a8d\u53ef\u3055\u308c\u305f\u7814\u7a76\u6240\u306b\u306e\u307f\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u7de9\u548c\u30b9\u30c6\u30c3\u30d7\u306f\u3001\u958b\u767a\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3057\u3001\u30c6\u30b9\u30c8\u30b5\u30a4\u30c8\u3067\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u9ad8\u901f\u5316\u3059\u308b\u3068\u540c\u6642\u306b\u3001\u4ed6\u306e\u30d7\u30e9\u30a4\u30d9\u30fc\u30c8\u30c6\u30b9\u30c8\u958b\u767a\u306b\u30a4\u30f3\u30bb\u30f3\u30c6\u30a3\u30d6\u3092\u63d0\u4f9b\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001FDA\u306f\u7814\u7a76\u6240\u304c\u4ee5\u4e0b\u3092\u884c\u3046\u3053\u3068\u3092\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u30c6\u30b9\u30c8\u306e\u691c\u8a3c\u304c\u5b8c\u4e86\u3057\u305f\u3089\u3001FDA\u3078\u96fb\u5b50\u30e1\u30fc\u30eb\u3092\u9001\u4fe1\u3057\u3066\u3001\u30c6\u30b9\u30c8\u304c\u691c\u8a3c\u3055\u308c\u305f\u3053\u3068\u3092\u901a\u77e5\u3057\u307e\u3059\u3002<\/li>\n<li>EUA\u8a8d\u5b9a\u30c6\u30b9\u30c8\u3067\u6700\u521d\u306e5\u3064\u306e\u967d\u6027\u30b5\u30f3\u30d7\u30eb\u30685\u3064\u306e\u9670\u6027\u30b5\u30f3\u30d7\u30eb\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n<li>\u30c6\u30b9\u30c8\u306f\u691c\u8a3c\u3055\u308c\u305f\u304c\u3001FDA\u306f\u72ec\u7acb\u3057\u305f\u30ec\u30d3\u30e5\u30fc\u3092\u5b8c\u4e86\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u30c6\u30b9\u30c8\u30ec\u30dd\u30fc\u30c8\u306b\u793a\u3057\u307e\u3059\u3002<\/li>\n<li>\u30c6\u30b9\u30c8\u3092\u958b\u59cb\u304b\u308915\u65e5\u4ee5\u5185\u306bEUA\u3092\u63d0\u51fa\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>\u307e\u305f\u3001\u78ba\u8a8d\u8a66\u9a13\u306b\u5931\u6557\u3057\u305f\u30b5\u30f3\u30d7\u30eb\u304c\u3042\u308b\u5834\u5408\u3001\u307e\u305f\u306fFDA\u304cEUA\u3092\u627f\u8a8d\u3067\u304d\u306a\u3044\u5834\u5408\u306b\u5b9f\u884c\u3059\u308b\u624b\u9806\u306e\u6982\u8981\u3082\u793a\u3057\u307e\u3059\u3002\u30c6\u30b9\u30c8\u306e\u691c\u8a3c\u306b\u95a2\u3057\u3066\u3001\u691c\u8a3c\u306e\u305f\u3081\u306b\u5b9f\u884c\u3055\u308c\u308b\u30df\u30cb\u30de\u30e0\u30c6\u30b9\u30c8\u306e\u63a8\u5968\u4e8b\u9805\u306b\u306f\u3001\u691c\u51fa\u9650\u754c\uff08LoD\uff09\u3001\u81e8\u5e8a\u8a55\u4fa1\u3001\u5305\u62ec\u6027\u304a\u3088\u3073\u4ea4\u5dee\u53cd\u5fdc\u6027\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u30a6\u30a4\u30eb\u30b9\u6750\u6599\u306e\u5165\u624b\u53ef\u80fd\u6027\u304c\u9650\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u8003\u3048\u308b\u3068\u3001FDA\u3001CDC\u3001\u304a\u3088\u3073\u751f\u7269\u533b\u5b66\u5148\u7aef\u7814\u7a76\u958b\u767a\u6a5f\u95a2\uff08BARDA\uff09\u306f\u3001\u691c\u8a3c\u306e\u6e96\u5099\u304c\u3067\u304d\u305f\u3089\u3001\u691c\u67fb\u5ba4\u3078\u306e\u63d0\u4f9b\u3092\u512a\u5148\u3059\u308b\u3088\u3046\u8abf\u6574\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>EUA<\/strong><strong>\u30c6\u30b9\u30c8\u30b9\u30c6\u30fc\u30bf\u30b9<\/strong><\/h3>\n<p>CDC\u3001FDA\u3001\u304a\u3088\u3073BARDA\u306f\u3001IVD\u88fd\u9020\u696d\u8005\u304a\u3088\u3073\u7814\u7a76\u6a5f\u95a2\u3068\u5354\u529b\u3057\u3066\u3001\u300c\u3067\u304d\u308b\u3060\u3051\u65e9\u304f\u300dEUA\u8a8d\u8a3c\u3092\u767a\u884c\u3057\u3066\u3044\u307e\u3059\uff08\u6700\u65b0\u60c5\u5831\u306f\u3053\u3061\u3089\u3067\u78ba\u8a8d\u3067\u304d\u307e\u3059\uff09\u3002\u3053\u308c\u307e\u3067\u306e\u3068\u3053\u308d\u3001\u9023\u90a6\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5\uff08FD\uff06C\u6cd5\uff09\u306e\u30bb\u30af\u30b7\u30e7\u30f3564\u306b\u5f93\u3063\u30662019-nCoV\u30c6\u30b9\u30c8\u306eCDC\u57fa\u6e96\u3092\u6e80\u305f\u3059\u500b\u4eba\u306bIVD\u3092\u4f7f\u7528\u3059\u308b\u305f\u3081\u306b2\u3064\u306eEUA\u304c\u767a\u884c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<ol>\n<li>2020\u5e742\u67084\u65e5\u306b\u3001CDC\u306f\u3001\u4e0a\u6c17\u9053\u306a\u3089\u3073\u306b\u4e0b\u6c17\u9053\u30b5\u30f3\u30d7\u30eb\u304b\u3089\u306e2019-nCoV\u6838\u9178\u3092\u5b9a\u6027\u7684\u306b\u691c\u51fa\u3059\u308b\u305f\u3081\u306e2019-Novel Coronavirus\uff082019-nCoV\uff09Real-Time Reverse Transcriptase\uff08RT\uff09-PCR\u8a3a\u65ad\u30d1\u30cd\u30eb\u306eEUA\u8a8d\u53ef\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002<\/li>\n<li>2020\u5e742\u670829\u65e5\u3001FDA\u306f\u3001\u30cb\u30e5\u30fc\u30e8\u30fc\u30af\u5dde\u516c\u8846\u885b\u751f\u5c40\uff08CDC\uff09\u306b\u5bfe\u3057\u3066\u9f3b\u54bd\u982d\/\u54bd\u982d\u30b9\u30ef\u30d6\u304b\u3089\u306eSARS-CoV-2\u6838\u9178\u3092\u5b9a\u6027\u7684\u306b\u691c\u51fa\u3059\u308b\u305f\u3081\u306eSARS-CoV-2 Real-Time Reverse Transcriptase\uff08RT\uff09-PCR\u8a3a\u65ad\u30d1\u30cd\u30eb\u306b\u95a2\u3057\u3066EUA\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>COVID-19<\/strong><strong>\u306e\u751f\u4f53\u5916\u8a3a\u65ad\u30c6\u30b9\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u95a2\u3059\u308b<\/strong><strong>FDA<\/strong><strong>\u30a6\u30a7\u30d3\u30ca\u30fc<\/strong><\/h3>\n<p>2020\u5e743\u67082\u65e5\u306b\u3001FDA\u306f\u30a6\u30a7\u30d3\u30ca\u30fc\u3092\u958b\u50ac\u3057\u3001\u65b0\u305f\u306b\u516c\u958b\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u8981\u7d04\u3057\u3001\u30e1\u30fc\u30ab\u30fc\u3068\u30b9\u30dd\u30f3\u30b5\u30fc\u306b\u8cea\u7591\u5fdc\u7b54\uff08Q\uff06A\uff09\u30bb\u30c3\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u307e\u3057\u305f\u3002\u4ee5\u4e0b\u306f\u3001Q\uff06A\u30bb\u30c3\u30b7\u30e7\u30f3\u4e2d\u306bFDA\u304c\u884c\u3063\u305f\u8ffd\u52a0\u306e\u63a8\u5968\u4e8b\u9805\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u967d\u6027\u691c\u4f53\u306f\u691c\u67fb\u3092\u5236\u9650\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u88fd\u9020\u696d\u8005\u306fFDA\u306b\u96fb\u5b50\u30e1\u30fc\u30eb\u30ea\u30af\u30a8\u30b9\u30c8\u3092\u9001\u4fe1\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u3001\u6750\u6599\u3092\u5fc5\u8981\u3068\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u306e\u30ea\u30b9\u30c8\u306b\u8ffd\u52a0\u3055\u308c\u307e\u3059\u3002\u691c\u8a3c\u306e\u305f\u3081\u306e\u8ffd\u52a0\u306e\u7d4c\u8def\u3082\u5229\u7528\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>FDA\u306f\u627f\u8a8d\u3092\u52a0\u901f\u3059\u308b\u305f\u3081\u306b\u3001IVD\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u5b8c\u5168\u306a\u30d1\u30c3\u30b1\u30fc\u30b8\u3092\u5165\u624b\u3057\u305f\u3089\u3001EUA\u306e\u4e8b\u524d\u30d7\u30ed\u30bb\u30b9\u306e\u4e0b\u3067\u63d0\u51fa\u7269\u306e\u4e00\u90e8\u304c\u9001\u4fe1\u3055\u308c\u6b21\u7b2c\u3001\u653f\u5e9c\u6a5f\u95a2\u306f\u30ed\u30fc\u30ea\u30f3\u30b0\u30ec\u30d3\u30e5\u30fc\u3092\u958b\u59cb\u3067\u304d\u307e\u3059[Guidance Bulletin\u3001Updated 11-May -2017]\u3002\u7533\u8acb\u66f8\u306e\u6700\u7d42\u90e8\u5206\u304c\u63d0\u51fa\u3055\u308c\u308b\u3068\u3001FDA\u306f\u305d\u306e\u90e8\u5206\u306e\u307f\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u3053\u308c\u307e\u3067\u306b\u767a\u884c\u3055\u308c\u305f2\u3064\u306eEUA\u3067\u4f7f\u7528\u3055\u308c\u3001\u6700\u7d42\u63d0\u51fa\u304b\u308924\u6642\u9593\u4ee5\u5185\u306b\u6700\u7d42\u627f\u8a8d\u304c\u884c\u308f\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u533b\u7642\u5f93\u4e8b\u8005\u5411\u3051\u306e<\/strong><strong>NIOSH<\/strong><strong>\u627f\u8a8d\u30ec\u30b9\u30d4\u30ec\u30fc\u30bf\u30fc<\/strong><\/h3>\n<p>2020\u5e743\u67082\u65e5\u3001FDA\u306f\u3001\u533b\u7642\u5f93\u4e8b\u8005\u306b\u3088\u308b\u7279\u5b9a\u306eN95\u3092\u542b\u3080\u30ec\u30b9\u30d4\u30ec\u30fc\u30bf\u30fc\u306e\u7dca\u6025\u4f7f\u7528\u306b\u95a2\u3059\u308bEUA\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u3089\u306f\u901a\u5e38\u3001\u7523\u696d\u7528\u306b\u5099\u84c4\u3055\u308c\u3066\u3044\u308b\u3082\u306e\u3067\u3059\u3002\u5bfe\u8c61\u306e\u30ec\u30b9\u30d4\u30ec\u30fc\u30bf\u30fc\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059<\/p>\n<p>&nbsp;<\/p>\n<ol>\n<li>42CFR Part 84 [21 CFR 880]\u306b\u5f93\u3063\u3066\u3001\u56fd\u7acb\u52b4\u50cd\u5b89\u5168\u885b\u751f\u7814\u7a76\u6240\uff08NIOSH\uff09\u306b\u3088\u308a\u975e\u52d5\u529b\u7a7a\u6c17\u6d44\u5316\u5fae\u7c92\u5b50FFR\u3068\u3057\u3066\u627f\u8a8d\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u4f7f\u3044\u6368\u3066\u30d5\u30a3\u30eb\u30bf\u30ea\u30f3\u30b0\u30d5\u30a7\u30a4\u30b9\u30d4\u30fc\u30b9\u30de\u30b9\u30af\uff08FFR\uff09<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<ol start=\"2\">\n<li>NIOSH\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305fFFR\u306b\u306f\u3001COVID-19\u306e\u767a\u751f\u306b\u8d77\u56e0\u3059\u308bFFR\u4e0d\u8db3\u4e2d\u306b\u7740\u7528\u8005\u304c\u75c5\u539f\u6027\u306e\u751f\u7269\u5b66\u7684\u7a7a\u4e2d\u6d6e\u904a\u5fae\u7c92\u5b50\u306b\u66dd\u3055\u308c\u308b\u306e\u3092\u9632\u3050\u305f\u3081\u306b\u3001\u533b\u7642\u5f93\u4e8b\u8005\u304c\u533b\u7642\u74b0\u5883\u3067\u4f7f\u7528\u3059\u308b\u305f\u3081\u306b\u30e1\u30fc\u30ab\u30fc\u304c\u63a8\u5968\u3059\u308b\u6709\u52b9\u671f\u9593\u3092\u904e\u304e\u3066\u3044\u308b\u3082\u306e\u3082\u542b\u307e\u308c\u307e\u3059\u3002<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>FDA\u306b\u3088\u308b\u3068\u3001\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u7a7a\u4e2d\u6d6e\u904a\u7c92\u5b50\u306e\u52b9\u7387\u7684\u306a\u308d\u904e\u3092\u63d0\u4f9b\u3057\u3001\u30d5\u30a7\u30a4\u30b9\u30de\u30b9\u30af\u3088\u308a\u3082\u591a\u304f\u3092\u308d\u904e\u3059\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u901a\u5e38\u3001\u7523\u696d\u7528\u306b\u4f7f\u7528\u3055\u308c\u308b\u305f\u3081\u3001\u30c6\u30b9\u30c8\u7528\u306eFDA\u6a19\u6e96\u3092\u6e80\u305f\u3059\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u63aa\u7f6e\u306f\u3001\u533b\u7642\u6a5f\u95a2\u306e\u4e0d\u8db3\u306b\u3064\u306a\u304c\u3063\u305f\u500b\u4eba\u7528\u4fdd\u8b77\u5177\u306e\u6ce8\u6587\u5897\u52a0\u3078\u306e\u5bfe\u5fdc\u3067\u3059\u3002\u4ee3\u7406\u5e97\u306f\u3001\u3053\u308c\u3089\u306e\u88fd\u54c1\u306e\u9700\u8981\u306fCOVID-19\u306e\u767a\u751f\u304c\u7d9a\u304f\u306b\u3064\u308c\u3066\u5897\u52a0\u3057\u3001\u3053\u308c\u3089\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u6f5c\u5728\u7684\u306a\u4e0d\u8db3\u3092\u7de9\u548c\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3068\u8ff0\u3079\u307e\u3057\u305f\u3002\u305f\u3060\u3057\u3001\u4e00\u822c\u306e\u4eba\u306f\u7279\u5b9a\u306eNIOSH\u627f\u8a8d\u306e\u30ec\u30b9\u30d4\u30ec\u30fc\u30bf\u30fc\u3092\u4f7f\u7528\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>COVID-19<\/strong><strong>\u306e\u6cbb\u7642<\/strong><\/h3>\n<p>\u7c73\u56fd\u56fd\u7acb\u885b\u751f\u7814\u7a76\u6240\uff08NIH\uff09\u306b\u3042\u308b\u56fd\u7acb\u30a2\u30ec\u30eb\u30ae\u30fc\u611f\u67d3\u75c7\u7814\u7a76\u6240\uff08NIAID\uff09\u306f\u3001\u30aa\u30de\u30cf\u306e\u30cd\u30d6\u30e9\u30b9\u30ab\u5927\u5b66\u533b\u7642\u30bb\u30f3\u30bf\u30fc\uff08UNMC\uff09\u3067\u884c\u308f\u308c\u305f\u3001COVID-19\u3068\u8a3a\u65ad\u3055\u308c\u305f\u5165\u9662\u4e2d\u306e\u6210\u4eba\u60a3\u8005\u306b\u304a\u3051\u308b\u6cbb\u9a13\u85ac\uff08IND\uff09\u30ec\u30e0\u30c7\u30b7\u30d3\u30eb\u3092\u542b\u3080\u65b0\u898f\u6cbb\u7642\u85ac\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u7121\u4f5c\u70ba\u5316\u4e8c\u91cd\u76f2\u691c\u30d7\u30e9\u30bb\u30dc\u5bfe\u7167\u7b2c2\u76f8\u8a66\u9a13\u306e\u30b9\u30dd\u30f3\u30b5\u30fc\u3067\u3059\u3002<\/p>\n<p>\u3053\u306e\u7814\u7a76\u306f\u300118\u6b73\u4ee5\u4e0a\u306e394\u4eba\u306e\u60a3\u8005\u3092\u52df\u96c6\u3057\u3066\u304a\u308a\u3001\u3055\u307e\u3056\u307e\u306a\u6cbb\u9a13\u6cbb\u7642\u85ac\u3068\u30d7\u30e9\u30bb\u30dc\u306e\u4e00\u9023\u306e2\u7fa4\u6bd4\u8f03\u3067\u69cb\u6210\u3055\u308c\u3001\u4e2d\u9593\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u3088\u308a\u65b0\u3057\u3044\u7fa4\u3092\u8ffd\u52a0\u3057\u3001\u7121\u76ca\u6027\u3001\u6709\u52b9\u6027\u307e\u305f\u306f\u5b89\u5168\u6027\u306e\u6307\u6a19\u306b\u57fa\u3065\u304f\u65e9\u671f\u4e2d\u6b62\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002\u4e3b\u8981\u306a\u30a2\u30a6\u30c8\u30ab\u30e0\u6307\u6a19\u306f\u3001\u91cd\u75c7\u5ea6\u30927\u6bb5\u968e\u3067\u8a55\u4fa1\u3057\u300115\u65e5\u76ee\u306b\u5831\u544a\u3055\u308c\u305f\u5404\u91cd\u75c7\u5ea6\u306e\u88ab\u9a13\u8005\u306e\u5272\u5408\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<blockquote><p><strong>\u56fd\u7acb\u30a2\u30ec\u30eb\u30ae\u30fc\u611f\u67d3\u75c7\u7814\u7a76\u6240\uff08<\/strong><strong>NIAID<\/strong><strong>\uff09\u306f\u3001\u5165\u9662\u4e2d\u306e\u6210\u4eba\u306b\u304a\u3051\u308b\u6cbb\u9a13\u85ac\uff08<\/strong><strong>IND<\/strong><strong>\uff09\u3092\u542b\u3080\u65b0\u898f\u6cbb\u7642\u85ac\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306b\u3001<\/strong><strong>COVID-19<\/strong><strong>\u3068\u8a3a\u65ad\u3055\u308c\u305f\u60a3\u8005\u306b\u5bfe\u3059\u308b\u7121\u4f5c\u70ba\u5316\u4e8c\u91cd\u76f2\u691c\u30d7\u30e9\u30bb\u30dc\u5bfe\u7167\u30d5\u30a7\u30fc\u30ba<\/strong><strong>2<\/strong><strong>\u3092\u652f\u63f4\u3057\u3066\u3044\u307e\u3059\u3002<\/strong><\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u30ef\u30af\u30c1\u30f3<\/strong><\/h3>\n<p>\u30b9\u30dd\u30f3\u30b5\u30fc\u30ec\u30dd\u30fc\u30c8\u306b\u3088\u308b\u3068\u3001Codagenix, Inc\u306f\u30a4\u30f3\u30c9\u8840\u6e05\u7814\u7a76\u6240\u3068\u5171\u540c\u3067\u3001SARS-CoV-2\u306e2019-nCoV\u682a\u306b\u3088\u3063\u3066\u5f15\u304d\u8d77\u3053\u3055\u308c\u308bCOVID-19\u306e\u6f5c\u5728\u7684\u306a\u4e88\u9632\u306e\u305f\u3081\u306e\u5f31\u6bd2\u5316\u751f\u30ef\u30af\u30c1\u30f3\u3092\u7814\u7a76\u3057\u3066\u3044\u307e\u3059\u30022020\u5e742\u6708\u307e\u3067\u306b\u3001\u591a\u6570\u306enCoV\u30ef\u30af\u30c1\u30f3\u5019\u88dc\u30b2\u30ce\u30e0\u304c\u8a2d\u8a08\u3055\u308c\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u524d\u306b\u3001in vivo\u3067\u30ef\u30af\u30c1\u30f3\u30a6\u30a4\u30eb\u30b9\u3092\u5897\u6b96\u304a\u3088\u3073\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3092\u8a08\u753b\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>Novavax, Inc\u306f\u3001COVID-19\u3092\u4e88\u9632\u3059\u308b\u305f\u3081\u306e\u65b0\u3057\u3044\u30ef\u30af\u30c1\u30f3\u3092\u958b\u767a\u3057\u3066\u3044\u307e\u3059\u3002\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u3001\u30d2\u30c8\u8a66\u9a13\u306b\u6700\u9069\u306a\u5019\u88dc\u3092\u7279\u5b9a\u3059\u308b\u524d\u306b\u3001\u52d5\u7269\u30e2\u30c7\u30eb\u3067\u8907\u6570\u306e\u30ca\u30ce\u7c92\u5b50\u30ef\u30af\u30c1\u30f3\u5019\u88dc\u3092\u4f5c\u6210\u3057\u3001\u73fe\u5728\u8a55\u4fa1\u3057\u3066\u3044\u307e\u3059\uff082020\u5e74\u6625\u306e\u7d42\u308f\u308a\u307e\u3067\u306b\u958b\u59cb\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3059\uff09\u3002\u4e2d\u6771\u547c\u5438\u5668\u75c7\u5019\u7fa4\uff08MERS\uff09\u304a\u3088\u3073\u91cd\u75c7\u6025\u6027\u547c\u5438\u5668\u75c7\u5019\u7fa4\uff08SARS\uff09\u306b\u95a2\u3059\u308bNovavax\u306e\u7d4c\u9a13\u306f\u3001COVID-19\u306b\u5bfe\u3059\u308b\u8fc5\u901f\u306a\u5bfe\u5fdc\u80fd\u529b\u3092\u63d0\u4f9b\u3059\u308b\u3068\u767a\u8868\u3057\u3066\u3044\u307e\u3059\u3002\u30b9\u30dd\u30f3\u30b5\u30fc\u306eCOVID-19\u30ef\u30af\u30c1\u30f3\u5019\u88dc\u306f\u3001\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u30b9\u30d1\u30a4\u30af\u30bf\u30f3\u30d1\u30af\u8cea\u306b\u7531\u6765\u3059\u308b\u6297\u539f\u3092\u751f\u7523\u3059\u308b\u72ec\u81ea\u306e\u7d44\u63db\u3048\u30bf\u30f3\u30d1\u30af\u8cea\u30ca\u30ce\u7c92\u5b50\u6280\u8853\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u4f7f\u7528\u3057\u3066\u4f5c\u6210\u3055\u308c\u307e\u3057\u305f\u3002Novavax\u306f\u3001\u72ec\u81ea\u306eMatrix-M\u30a2\u30b8\u30e5\u30d0\u30f3\u30c8\u3068COVID-19\u30ef\u30af\u30c1\u30f3\u5019\u88dc\u3092\u4f75\u7528\u3057\u3066\u3001\u514d\u75ab\u5fdc\u7b54\u3092\u5f37\u5316\u3059\u308b\u4e88\u5b9a\u3067\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u75be\u60a3\u306b\u95a2\u3059\u308b\u6700\u65b0\u306e\u898f\u5236\u306e\u6d1e\u5bdf\u304a\u3088\u3073\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3064\u3044\u3066\u6700\u65b0\u60c5\u5831\u3092\u5165\u624b\u3059\u308b\u306b\u306f\u3001<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a>\u3092\u3054\u5229\u7528\u304f\u3060\u3055\u3044\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>JAIME POLYCHRONES Medical Writer, Cortellis Regulatory Intelligence Clarivate &nbsp; \u82f1\u8a9e\u539f\u6587 2020\u5e743\u670811\u65e5 SARS-CoV2\u304c\u5e83\u304c\u308a\u7d9a\u3051\u3001\u305d\u306e\u7d50\u679c\u3068\u3057\u3066Coronavirus Disease 2019\uff08COVID-19\uff09\u306e\u7f79\u60a3\u8005\u304c\u767a\u751f\u3057\u3066\u3044\u307e\u3059\u3002\u79c1\u9054\u306f\u533b\u7642\u73fe\u5834\u306b\u304a\u3051\u308bIVD\u30c6\u30b9\u30c8\u3068\u30ec\u30b9\u30d4\u30ec\u30fc\u30bf\u30fc\u306e\u4f7f\u7528\u306b\u95a2\u3059\u308bFDA\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u8abf\u67fb\u3057\u3001\u73fe\u5728\u306e\u6cbb\u7642\u3068\u30ef\u30af\u30c1\u30f3\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u306b\u7126\u70b9\u3092\u5f53\u3066\u307e\u3057\u305f\u3002 &nbsp; \u4e2d\u56fd\u306e\u6e56\u5317\u7701\u6b66\u6f22\u5e02\u3067\u6700\u521d\u306b\u691c\u51fa\u3055\u308c\u305f\u65b0\u3057\u3044\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306f\u3001\u73fe\u5728\u3001\u7c73\u56fd\u3092\u542b\u3080\u4e16\u754c\u306e50\u4ee5\u4e0a\u306e\u5834\u6240\u3067\u691c\u51fa\u3055\u308c\u3066\u304a\u308a\u3001\u6bce\u65e5\u591a\u304f\u306e\u75c7\u4f8b\u304c\u767a\u8868\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30a6\u30a4\u30eb\u30b9\u306fSARS-CoV2\u3068\u547c\u3070\u308c\u3001\u60a3\u8005\u306b\u751f\u3058\u308b\u75be\u60a3\u306fCoronavirus Disease 2019\uff08COVID-19\uff09\u3068\u547c\u3070\u308c\u307e\u3059\u3002FDA\u306b\u3088\u308b\u3068\u3001\u30a6\u30a4\u30eb\u30b9\u306e\u6025\u901f\u306a\u62e1\u6563\u80fd\u529b\u3092\u8003\u3048\u308b\u3068\u3001\u7c73\u56fd\u306e\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u3068\u793e\u4f1a\u5168\u4f53\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3068\u3044\u3046\u3002 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