{"id":141280,"date":"2020-08-25T00:42:35","date_gmt":"2020-08-25T00:42:35","guid":{"rendered":"https:\/\/labinsights.com\/acf_article\/%e9%80%9a%e8%bf%87%e5%8d%b3%e6%97%b6%e6%a3%80%e6%b5%8b%e5%ba%94%e5%af%b9%e7%96%ab%e6%83%85%e7%ae%a1%e7%90%86%ef%bc%9a%e4%b8%93%e8%ae%bf-gerald-kost-%e5%8d%9a%e5%a3%ab\/"},"modified":"2026-01-21T12:02:18","modified_gmt":"2026-01-21T12:02:18","slug":"point-of-care-testing-for-pandemic-management-an-interview-with-dr-gerald-kost","status":"publish","type":"acf_article","link":"https:\/\/labinsights.com\/zhcn\/operations\/point-of-care\/point-of-care-testing-for-pandemic-management-an-interview-with-dr-gerald-kost\/","title":{"rendered":"\u901a\u8fc7\u5373\u65f6\u68c0\u6d4b\u5e94\u5bf9\u75ab\u60c5\u7ba1\u7406\uff1a\u4e13\u8bbf Gerald Kost \u535a\u58eb"},"content":{"rendered":"<p><em>\u4f5c\u4e3a\u52a0\u5dde\u5927\u5b66\u6234\u7ef4\u65af\u5206\u6821\u533b\u5b66\u9662\u5373\u65f6\u68c0\u6d4b\u6559\u5b66\u4e0e\u7814\u7a76\u4e2d\u5fc3 (POCT-CTR) \u4e3b\u4efb\u517c\u75c5\u7406\u5b66\u4e0e\u5b9e\u9a8c\u5ba4\u533b\u5b66\u540d\u8a89\u6559\u6388\uff0cGerald Kost \u535a\u58eb\u662f\u5168\u7403\u5373\u65f6\u68c0\u6d4b (POCT) \u9886\u57df\u7684\u9886\u519b\u4e13\u5bb6\u4e4b\u4e00\u3002\u4ed6\u8fd8\u662f 2020\u20132021 \u5e74\u5ea6\u4e1c\u76df\u5730\u533a\u7684\u5bcc\u5e03\u8d56\u7279\u5b66\u8005\u3002\u5728\u672c\u95ee\u7b54\u4e2d\uff0c\u4ed6\u5206\u4eab\u4e86\u4ee5\u4e0b\u65b9\u9762\u7684\u89c1\u89e3\uff1a\u8bc4\u4f30\u7528\u4e8e COVID-19 \u7ba1\u7406\u7684\u5168\u65b0 POCT\uff0c\u5728\u4e34\u5e8a\u5b9e\u8df5\u4e2d\u5b9e\u65bd\u8fd9\u4e9b\u68c0\u6d4b\uff0c\u4ee5\u53ca\u5236\u5b9a\u653f\u7b56\u4ee5\u63a8\u52a8\u8bca\u65ad\u521b\u65b0\u5e76\u5e2e\u52a9\u9632\u6b62\u672a\u6765\u7206\u53d1\u9ad8\u5ea6\u4f20\u67d3\u6027\u75be\u75c5\u3002<\/em> <\/p>\n<h2 class=\"text-align-justify\" style=\"font-family: Inter !important; 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font-weight: 500 !important; font-size: 24px !important; line-height: 32px !important; letter-spacing: 0px !important;\">\u5bf9\u4e8e COVID-19 \u7684 POCT\uff0c\u4e3b\u7ba1\u90e8\u95e8\u53ef\u4ee5\u8003\u8651\u54ea\u4e9b\u5177\u6709\u5e94\u7528\u524d\u666f\u7684\u68c0\u6d4b\u65b9\u6cd5\uff1f<\/h3>\n<p> \u4efb\u4f55\u5728\u7b2c 3 \u7ea7\u4e2d\u83b7\u5f97\u5ba2\u89c2\u9ad8\u8868\u73b0\u786e\u8ba4\u7684\u68c0\u6d4b\uff0c\u90fd\u5728\u5f53\u524d\u75ab\u60c5\u53ca\u672a\u6765\u65b0\u53d1\u75ab\u60c5\u7684\u7ba1\u7406\u4e2d\u5177\u6709\u6781\u9ad8\u7684\u5e94\u7528\u524d\u666f\u3002\u5176\u4e2d\u5305\u62ec\u7528\u4e8e SARS-CoV-2 \u521d\u59cb\u68c0\u6d4b\u7684\u5206\u5b50\u8bca\u65ad\u6d4b\u8bd5\uff0c\u4ee5\u53ca\u7528\u4e8e\u8bc4\u4f30\u611f\u67d3\u6216\u63a5\u79cd\u75ab\u82d7\u540e\u514d\u75ab\u53cd\u5e94\u7684\u6297\u4f53\u68c0\u6d4b\u3002\u4f9d\u636e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u7d27\u6025\u4f7f\u7528\u6388\u6743 \u6279\u51c6\u7684\u68c0\u6d4b\u5217\u4e8e\u53c2\u8003\u6587\u732e 10\u3002  \u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u5e02\u573a\u4e0a\u7684\u8bb8\u591a\u68c0\u6d4b\u90fd\u8868\u73b0\u4e0d\u4f73\u3002POCT \u4e0d\u5e94\u6210\u4e3a\u68c0\u6d4b\u6709\u8bef\u7684\u7406\u7531\u3002\u5728\u5c06 POCT \u7528\u4e8e COVID-19 \u68c0\u6d4b\u4e4b\u524d\uff0c\u4fdd\u5065\u4ece\u4e1a\u4eba\u5458\u5e94\u5bf9\u5176\u6027\u80fd\u8fdb\u884c\u8bc4\u4f30\u3002 <\/p>\n<h3 class=\"text-align-justify\" style=\"font-family: Inter !important; font-weight: 500 !important; font-size: 24px !important; line-height: 32px !important; letter-spacing: 0px !important;\">\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u4e13\u4e1a\u4eba\u5458\u5982\u4f55\u5728 COVID-19 \u7ba1\u7406\u4e2d\u52a9\u529b POC \u7684\u90e8\u7f72\uff1f<\/h3>\n<p> \u4ee5\u4e0b\u5341\u4e8c\u9879\u5efa\u8bae\u5c55\u793a\u4e86\u5b9e\u9a8c\u5ba4\u4e13\u4e1a\u4eba\u5458\u5982\u4f55\u901a\u8fc7\u90e8\u7f72 POCT \u6765\u904f\u5236\u75ab\u60c5\u3001\u5e2e\u52a9\u6025\u6027\u611f\u67d3\u60a3\u8005\uff0c\u5e76\u52a0\u901f\u51b3\u7b56\u3001\u6cbb\u7597\u548c\u5eb7\u590d\u8fc7\u7a0b\u3002<\/p>\n<ul>\n<li>\u5728\u514d\u4e0b\u8f66\/\u8f66\u5185\/\u8f66\u9053\u5f0f\u91c7\u6837\u70b9\u3001\u6b65\u884c\u91c7\u6837\u70b9\u53ca\u4e34\u65f6\u68c0\u6d4b\u70b9\u4e2d\u5b89\u5168\u5730\u91c7\u96c6\u6837\u672c\u3001\u7b5b\u67e5\u5e76\u8bc4\u4f30\u53d7\u68c0\u8005\uff0c\u4ee5\u9632\u6b62\u4f20\u64ad<\/li>\n<li>\u901a\u8fc7\u4f18\u5f02\u7684\u9633\u6027\u9884\u6d4b\u503c [TP\/(TP + FP) ]\u548c\u9634\u6027\u9884\u6d4b\u503c [TN\/(TN + FN)] \u786e\u4fdd\u9ad8\u6d4b\u8bd5\u6027\u80fd<\/li>\n<li>\u901a\u8fc7\u51cf\u5c11\u6025\u8bca\u5ba4\u538b\u529b\u3001\u964d\u4f4e\u4e0d\u5fc5\u8981\u7684\u4f4f\u9662\u7387\u53ca\u4f4e\u98ce\u9669\u60a3\u8005\u7684\u518d\u5165\u9662\uff0c\u4ece\u800c\u51cf\u8f7b\u533b\u9662\u7cfb\u7edf\u7684\u8d1f\u62c5<\/li>\n<li>\u533a\u5206\u5e38\u89c1\u7684 A\/B \u6d41\u884c\u6027\u611f\u5192\u4e0e COVID-19<\/li>\n<li>\u901a\u8fc7\u5e7f\u6cdb\u63d0\u4f9b\u68c0\u6d4b\u548c\u81ea\u6211\u68c0\u6d4b\uff0c\u8bc6\u522b COVID-19 \u7684\u9690\u5f62\u4f20\u64ad<\/li>\n<li>\u52a0\u901f\u5bf9 SARS-CoV-2 \u611f\u67d3\u8005\u7684\u5206\u5b50\u8bca\u65ad\u3001\u5206\u8bca\u3001\u9694\u79bb\u548c\u51b3\u7b56<\/li>\n<li>\u534f\u52a9\u516c\u5171\u536b\u751f\u90e8\u95e8\u5f00\u5c55\u611f\u67d3\u8005\u63a5\u89e6\u8005\u8ffd\u8e2a<\/li>\n<li>\u4f7f\u7528\u6307\u5c16\u8109\u640f\u8840\u6c27\u5b9a\u91cf\u6cd5\uff08\u8840\u6c27\u9971\u548c\u5ea6\u76d1\u6d4b\uff09\u76d1\u6d4b\u201c\u9690\u6027\u4f4e\u6c27\u8840\u75c7\u201d\uff08\u80ba\u90e8\u529f\u80fd\u53d7\u635f\uff09<\/li>\n<li>\u8bca\u65ad\u8840\u6d41\u75c5\u539f\u4f53\uff0c\u786e\u5b9a\u6297\u5fae\u751f\u7269\u836f\u7269\u8010\u836f\u6027\uff0c\u5e76\u52a0\u5feb\u9488\u5bf9\u5408\u5e76\u611f\u67d3\u548c\u8113\u6bd2\u75c7\u7684\u9776\u5411\u6cbb\u7597<\/li>\n<li>\u5bf9\u80ba\u90e8\u611f\u67d3\u60a3\u8005\u53ca\u56e0 ARDS \u5904\u4e8e\u5371\u91cd\u72b6\u6001\u7684\u60a3\u8005\u8fdb\u884c\u75c5\u60c5\u5206\u671f<\/li>\n<li>\u901a\u8fc7\u6d4b\u91cf\u52a8\u8109\u8840\u6c14\u548c\u5438\u5165\u6c27\u6d53\u5ea6\uff0c\u6839\u636e P\/F \u6bd4\u503c (PaO2\/FiO2) \u8bc4\u4f30 ARDS \u7684\u4e25\u91cd\u7a0b\u5ea6\uff1a\uff1e200 \u4e3a\u8f7b\u5ea6\uff0c100\u2013200 \u4e3a\u4e2d\u5ea6\uff0c\uff1c100 \u4e3a\u91cd\u5ea6<\/li>\n<li>\u8bc4\u4f30\u836f\u7269\u6cbb\u7597\u671f\u95f4\u7684\u75c5\u6bd2\u8f7d\u91cf\u3001\u7f13\u89e3\u671f\u95f4\u7684 IgG \u548c IgM \u514d\u75ab\u4ee5\u53ca\u75ab\u82d7\u63a5\u79cd\u540e\u7684\u6297\u4f53\u6ef4\u5ea6<\/li>\n<\/ul>\n<h3 class=\"text-align-justify\" style=\"font-family: Inter !important; font-weight: 500 !important; font-size: 24px !important; line-height: 32px !important; letter-spacing: 0px !important;\">\u653f\u5e9c\u548c\u51b3\u7b56\u8005\u5e94\u5982\u4f55\u652f\u6301\u5728\u5e94\u5bf9 COVID-19 \u7684\u8fc7\u7a0b\u4e2d\u63a8\u5e7f POCT \u7684\u5e94\u7528\uff1f<\/h3>\n<p> \u5404\u56fd\u653f\u5e9c\u548c\u51b3\u7b56\u8005\u5e94\u8d44\u52a9 POCT \u7684\u7814\u7a76\u548c\u5f00\u53d1\uff0c\u4ee5\u68c0\u6d4b\u75be\u75c5\u3001\u8bc4\u4f30\u514d\u75ab\u53cd\u5e94\u5e76\u5236\u5b9a\u5c06\u8bca\u65ad\u4e0e\u6cbb\u7597\u65b9\u6848\u76f8\u7ed3\u5408\u7684\u7b56\u7565\u3002\u4ed6\u4eec\u5e94\u63d0\u4f9b\u878d\u8d44\u673a\u5236\u5e76\u63a8\u5e7f\u5546\u4e1a\u6a21\u5f0f\uff0c\u4ee5\u5e2e\u52a9\u521d\u521b\u4f01\u4e1a\u4e3a SARS-CoV-2 \u53d1\u660e\u65b0\u578b POCT \u4ea7\u54c1\u3002 \u5e94\u5236\u5b9a\u56fd\u5bb6\u7ea7\u68c0\u6d4b\u6307\u5357\uff0c\u5e76\u4e3a\u666e\u901a\u516c\u4f17\u63d0\u4f9b\u514d\u8d39\u7684\u68c0\u6d4b\u670d\u52a1\u3002\u91cd\u8981\u7684\u662f\uff0c\u5404\u56fd\u653f\u5e9c\u548c\u51b3\u7b56\u8005\u5e94\u5f00\u5c55\u516c\u5171\u536b\u751f\u5ba3\u4f20\u548c\u5065\u5eb7\u6559\u80b2\u6d3b\u52a8\uff0c\u786e\u4fdd\u516c\u4f17\u4e86\u89e3 POCT \u5728\u75be\u75c5\u76d1\u6d4b\u3001\u5bc6\u5207\u63a5\u89e6\u8005\u8ffd\u8e2a\u53ca\u75be\u75c5\u7ba1\u7406\u4e2d\u7684\u7528\u9014\u548c\u4f5c\u7528\u3002<\/p>\n<h3 class=\"text-align-justify\" style=\"font-family: Inter !important; font-weight: 500 !important; font-size: 24px !important; line-height: 32px !important; letter-spacing: 0px !important;\">\u6211\u4eec\u53ef\u4ee5\u4ece\u4ee5\u5f80\u7684\u75ab\u60c5\u4e2d\u6c72\u53d6\u54ea\u4e9b\u7ecf\u9a8c\uff0c\u6765\u6307\u5bfc POC \u7b56\u7565\u5728\u5e94\u5bf9 COVID-19 \u4e2d\u7684\u5b9a\u4f4d\uff1f<\/h3>\n<p> \u897f\u975e\u57c3\u535a\u62c9\u75ab\u60c5\u8ba9\u6211\u4eec\u6c72\u53d6\u4e86\u8bb8\u591a\u91cd\u8981\u6559\u8bad\uff0c\u4e3a\u5e94\u5bf9 COVID-19 \u5371\u673a\u63d0\u4f9b\u4e86\u5b9d\u8d35\u7ecf\u9a8c\uff0c\u4f46\u6b64\u7c7b\u5efa\u8bae\u3001\u6218\u7565\u548c\u6280\u672f\u5f00\u53d1\uff0c\u7279\u522b\u662f\u5728 POCT \u65b9\u9762\uff0c\u5374\u5728\u5f88\u5927\u7a0b\u5ea6\u4e0a\u88ab\u5ffd\u89c6\u4e86\u3002\u6211\u4eec\u5fc5\u987b\u91c7\u53d6\u884c\u52a8\uff0c\u9632\u6b62\u7c7b\u4f3c\u60c5\u51b5\u91cd\u6f14\u3002\u6709\u5173\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u53c2\u9605\u300a\u5168\u7403\u5373\u65f6\u68c0\u6d4b\uff1a\u707e\u5bb3\u3001\u7a81\u53d1\u4e8b\u4ef6\u4e0e\u516c\u5171\u536b\u751f\u97e7\u6027\u7b56\u7565\u300b\u4ee5\u53ca\u4e0b\u65b9\u7684\u53c2\u8003\u6587\u732e 7 \u548c 8\u3002Mark Shephard \u535a\u58eb\u7684\u300a\u5168\u7403\u5373\u65f6\u68c0\u6d4b\u5b9e\u7528\u6307\u5357\u300b\u4e5f\u63d0\u4f9b\u4e86\u91cd\u8981\u53c2\u8003\u5185\u5bb9\u3002<\/p>\n<h3 class=\"text-align-justify\" style=\"font-family: Inter !important; font-weight: 500 !important; font-size: 24px !important; line-height: 32px !important; letter-spacing: 0px !important;\">\u6559\u80b2\u673a\u6784\u53ef\u4ee5\u5982\u4f55\u652f\u6301 POCT \u6280\u672f\u4e0e\u5b9e\u8df5\u65b9\u9762\u7684\u57f9\u8bad\uff1f<\/h3>\n<p> \u516c\u5171\u536b\u751f\u5b66\u9662\u5fc5\u987b\u66f4\u65b0\u8bfe\u7a0b\u4f53\u7cfb\uff0c\u5c06 POCT \u57f9\u8bad\u7eb3\u5165\u5176\u4e2d\u3002COVID-19 \u5927\u6d41\u884c\u5df2\u5145\u5206\u8bc1\u660e\uff0c\u5728\u4eba\u4eec\u91cd\u8fd4\u5de5\u4f5c\u5c97\u4f4d\u65f6\uff0c\u9700\u8981\u4f9d\u8d56 POCT \u7b56\u7565\u8fdb\u884c\u611f\u67d3\u68c0\u6d4b\u3001\u63a5\u89e6\u8005\u8ffd\u8e2a\u53ca\u514d\u75ab\u53cd\u5e94\u8bb0\u5f55\u3002\u7531\u4e8e POCT \u5728\u516c\u5171\u536b\u751f\u6559\u80b2\u4e2d\u957f\u671f\u672a\u53d7\u5230\u91cd\u89c6\uff0c\u6211\u4eec\u5728\u672c\u4e16\u7eaa\u6700\u5927\u516c\u5171\u536b\u751f\u5371\u673a\u4e2d\u5b9e\u65bd POCT \u7684\u51c6\u5907\u660e\u663e\u4e0d\u8db3\u3002\u5173\u4e8e POCT \u8bfe\u7a0b\u8bbe\u7f6e\u53ca\u516c\u5171\u536b\u751f\u9886\u57df\u8ba4\u8bc1\u7684\u66f4\u591a\u8ba8\u8bba\uff0c\u8bf7\u53c2\u9605\u4e0b\u65b9\u53c2\u8003\u6587\u732e 5 \u548c 6\u3002<\/p>\n<h3 class=\"text-align-justify\" style=\"font-family: Inter !important; font-weight: 500 !important; font-size: 24px !important; line-height: 32px !important; letter-spacing: 0px !important;\">POCT \u7cfb\u7edf\u5e94\u5982\u4f55\u7528\u4e8e\u9884\u6d4b\u4e0b\u4e00\u6b21\u5927\u6d41\u884c\uff1f<\/h3>\n<p> \u5404\u56fd\u5c1a\u672a\u4e3a\u4e0b\u4e00\u6b21\u75ab\u60c5\u505a\u597d\u51c6\u5907\u3002\u4e16\u754c\u5df2\u7ecf\u6539\u53d8\uff0cPOC \u9886\u57df\u4e5f\u5fc5\u987b\u968f\u4e4b\u6539\u53d8\u3002\u63a8\u52a8\u53d8\u9769\u7684\u4e00\u79cd\u65b9\u5f0f\uff0c\u662f\u901a\u8fc7\u201c\u5373\u65f6\u68c0\u6d4b\u5b66\u201d\u8fd9\u4e00\u517c\u5177\u521b\u65b0\u6027\u4e0e\u5b9e\u8df5\u5e38\u8bc6\u7684\u672a\u6765\u533b\u5b66\u6982\u5ff5\u3002\u5373\u65f6\u68c0\u6d4b\u5b66\u7531\u4e2d\u56fd\u6b66\u6c49\u5218\u9521\u5149\u6559\u6388\u9886\u5bfc\u7684\u56e2\u961f\u63d0\u51fa\uff0c\u662f\u4e00\u95e8\u65b0\u5174\u533b\u5b66\u5b66\u79d1\uff0c\u5176\u6838\u5fc3\u5728\u4e8e\u5229\u7528 POCT \u5feb\u901f\u83b7\u5f97\u68c0\u6d4b\u7ed3\u679c\uff0c\u52a0\u901f\u6cbb\u7597\u51b3\u7b56\uff0c\u5e76\u51cf\u8f7b\u533b\u7597\u7ecf\u6d4e\u8d1f\u62c5\u3002\u5feb\u901f\u3001\u51c6\u786e\u548c\u5b89\u5168\u7684 POCT \u5c06\u6709\u52a9\u4e8e\u5404\u56fd\u5728\u4e0b\u4e00\u6b21\u4f20\u67d3\u75c5\u66b4\u53d1\u5728\u5168\u7403\u8303\u56f4\u5185\u8513\u5ef6\u4e4b\u524d\uff0c\u53ca\u65e9\u5c06\u5176\u904f\u5236\u3002<img decoding=\"async\" class=\" size-full wp-image-84740\" src=\"\/wp-content\/uploads\/2020\/08\/Kost-image2-2ff-scaled.jpg\" alt=\"Kostimage2\" width=\"2560\" height=\"1920\" data-entity-type=\"file\" data-entity-uuid=\"35646207-b3f0-4a8e-90ee-5e7ac6d17ed0\" title=\"\" srcset=\"https:\/\/labinsights.com\/app\/uploads\/2020\/08\/Kost-image2-2ff-scaled.jpg 2560w, https:\/\/labinsights.com\/app\/uploads\/2020\/08\/Kost-image2-2ff-268x201.jpg 268w, https:\/\/labinsights.com\/app\/uploads\/2020\/08\/Kost-image2-2ff-1024x768.jpg 1024w, https:\/\/labinsights.com\/app\/uploads\/2020\/08\/Kost-image2-2ff-768x576.jpg 768w, https:\/\/labinsights.com\/app\/uploads\/2020\/08\/Kost-image2-2ff-1536x1152.jpg 1536w, https:\/\/labinsights.com\/app\/uploads\/2020\/08\/Kost-image2-2ff-2048x1536.jpg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/> <\/p>\n<h3 class=\"text-align-justify\" style=\"font-family: Inter !important; font-weight: 500 !important; font-size: 24px !important; line-height: 32px !important; letter-spacing: 0px !important;\">\u53c2\u8003\u6587\u732e <\/h3>\n<p>[1]\u00a0Kost GJ.Designing and interpreting COVID-19 diagnostics: Mathematics, visual logistics, and low prevalence.Archives of Pathology and Laboratory Medicine. 2020. [open access] [2] Kost GJ.\u00a0Geospatial spread of antimicrobial resistance, bacterial and fungal threats to COVID-19 survival, and point-of-care solutions.Archives of Pathology and Laboratory Medicine. 2020. [open access] [3] Kost GJ.Geospatial hotspots need point-of-care strategies to help stop highly infectious outbreaks: Ebola and Coronavirus-19. Archives of Pathology and Laboratory Medicine. 2020. [open access] [4] Liu X, Zhu X, Kost GJ et al. The creation of point-of-careology.Point of Care. 2019;18(3):77-84. [open access] [5] Kost GJ.Geospatial science and point-of-care testing: Creating solutions for population access, emergencies, outbreaks, and disasters.\u00a0Frontiers in Public Health. 2019;7:329. [open access] [6] Kost GJ, et al. POCT curriculum and accreditation for public health: Enabling preparedness, response, and higher standards of care at points of need.Frontiers in Public Health. 2019;6:385. [open access] [7] Kost GJ.Molecular and point-of-care diagnostics for Ebola and new threats: National POCT policy and guidelines will stop epidemics.Expert Review of Molecular Diagnostics. 2018;18(7):657-673. [8] Kost GJ et al. Molecular detection and point-of-care testing in Ebola virus disease and other threats: a new global public health framework to stop outbreaks.Expert Review of Molecular Diagnostics. 2015;15(10):1245-1259. [9] Kost GJ, Curtis CM, Eds.Global Point of Care \u2014 Strategies for Disasters, Emergencies, and Public Health Resiliency.Washington DC: AACC Press-Elsevier, 2015. [contributed book, 701 pp.] [10] Food and Drug Administration, United States.In vitro diagnostics EUAs. https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/vitro-diagnostics-euas <strong>\u9e23\u8c22<\/strong>\u672c\u8bba\u6587\u5f97\u5230\u4e86\u6559\u5b66\u548c\u7814\u7a76\u5373\u65f6\u68c0\u6d4b\u4e2d\u5fc3 (POCT CTR) \u53ca\u5176\u4e3b\u4efb Kost \u535a\u58eb\u7684\u652f\u6301\u3002\u9644\u56fe\u548c\u8868\u683c\u7531\u6765\u81ea\u52a0\u5dde Knowledge Optimization \u7684 Davis \u63d0\u4f9b\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u4f5c\u4e3a\u52a0\u5dde\u5927\u5b66\u6234\u7ef4\u65af\u5206\u6821\u533b\u5b66\u9662\u5373\u65f6\u68c0\u6d4b\u6559\u5b66\u4e0e\u7814\u7a76\u4e2d\u5fc3 (POCT-CTR) \u4e3b\u4efb\u517c\u75c5\u7406\u5b66\u4e0e\u5b9e\u9a8c\u5ba4\u533b\u5b66\u540d\u8a89\u6559\u6388\uff0cGerald Kost \u535a\u58eb\u662f\u5168\u7403\u5373\u65f6\u68c0\u6d4b (POCT) \u9886\u57df\u7684\u9886\u519b\u4e13\u5bb6\u4e4b\u4e00\u3002\u4ed6\u8fd8\u662f 2020\u20132021 \u5e74\u5ea6\u4e1c\u76df\u5730\u533a\u7684\u5bcc\u5e03\u8d56\u7279\u5b66\u8005\u3002\u5728\u672c\u95ee\u7b54\u4e2d\uff0c\u4ed6\u5206\u4eab\u4e86\u4ee5\u4e0b\u65b9\u9762\u7684\u89c1\u89e3\uff1a\u8bc4\u4f30\u7528\u4e8e COVID-19 \u7ba1\u7406\u7684\u5168\u65b0 POCT\uff0c\u5728\u4e34\u5e8a\u5b9e\u8df5\u4e2d\u5b9e\u65bd\u8fd9\u4e9b\u68c0\u6d4b\uff0c\u4ee5\u53ca\u5236\u5b9a\u653f\u7b56\u4ee5\u63a8\u52a8\u8bca\u65ad\u521b\u65b0\u5e76\u5e2e\u52a9\u9632\u6b62\u672a\u6765\u7206\u53d1\u9ad8\u5ea6\u4f20\u67d3\u6027\u75be\u75c5\u3002 \u5728\u5f53\u524d\u75ab\u60c5\u4e0b\uff0c\u8981\u60f3\u6709\u6548\u90e8\u7f72 POCT\uff0c\u9700\u8981\u8003\u8651\u54ea\u4e9b\u5173\u952e\u56e0\u7d20\uff1f \u5728\u8bc4\u4f30 COVID-19 \u65b0\u68c0\u6d4b\u65b9\u6cd5\u65f6\uff0c\u4e00\u4e2a\u91cd\u8981\u8003\u91cf\u662f\u6d88\u9664\u5047\u9634\u6027\u7ed3\u679c\u3002\u4e3a\u6b64\uff0c\u65e0\u8bba\u662f\u5373\u65f6\u68c0\u6d4b\u8fd8\u662f\u5176\u4ed6\u5f62\u5f0f\u7684\u68c0\u6d4b\uff0c\u90fd\u9700\u8981\u5177\u5907\u8f83\u9ad8\u7684\u7075\u654f\u5ea6\uff0c\u9ad8\u7075\u654f\u5ea6\u7684\u754c\u5b9a\u6807\u51c6\u4e3a\uff1a\u771f\u9633\u6027\u7ed3\u679c (TP) \u4e0e\u771f\u9633\u6027\u7ed3\u679c\u52a0\u5047\u9634\u6027\u7ed3\u679c (FN) \u4e4b\u548c\u7684\u6bd4\u503c\uff0c\u5373 TP\/(TP + FN)\u3002\u68c0\u6d4b\u6027\u80fd\u7684\u6570\u5b66\u6a21\u578b\u5bf9\u4e8e\u5236\u5b9a\u5408\u7406\u7684\u68c0\u6d4b\u7b56\u7565\u81f3\u5173\u91cd\u8981\u3002\u4e0b\u56fe\u6bd4\u8f83\u4e86\u4e09\u79cd\u4e0d\u540c\u201c\u5c42\u7ea7\u201d\u7684\u68c0\u6d4b\uff0c\u5e76\u6839\u636e\u60a3\u75c5\u7387\u7684\u53d8\u5316\uff08\u6765\u6e90\u53c2\u8003\u6587\u732e 1\uff09\u5c55\u793a\u4e86\u5047\u9633\u6027\u4e0e\u771f\u9633\u6027\u7684\u6bd4\u503c (FP\/TP)\u3001\u9633\u6027\u9884\u6d4b\u503c (PPV)\u3001\u9634\u6027\u9884\u6d4b\u503c (NPV) \u4ee5\u53ca\u9519\u8bef\u6f0f\u62a5\u7387 (RFO)\u3002\u5728 2%\u20135% \u7684\u4f4e\u60a3\u75c5\u7387\u4e0b\uff0c\u9700\u8981\u91c7\u7528\u9ad8\u7075\u654f\u5ea6 (100%) \u548c\u9ad8\u7279\u5f02\u5ea6 (\u226599%) \u7684\u7b2c 3 \u7ea7\u68c0\u6d4b\u3002\u5927\u591a\u6570\u793e\u533a\u7684\u60a3\u75c5\u7387\u8f83\u4f4e\u3002\u5728\u6025\u8bca\u79d1\uff0c\u4e34\u5e8a\u533b\u751f\u63a5\u8bca\u7684\u611f\u67d3\u60a3\u8005\u66f4\u591a\uff0c\u56e0\u6b64 COVID-19 \u7684\u68c0\u524d\u6982\u7387\u5347\u9ad8\uff0c\u4e0e\u4e4b\u76f8\u5bf9\u5e94\uff0c\u5b9e\u9645\u60a3\u75c5\u7387\u4e5f\u968f\u4e4b\u589e\u52a0\u3002\u56e0\u6b64\uff0c\u60a3\u75c5\u7387\u53d6\u51b3\u4e8e\u5c31\u8bca\u73af\u5883\u3002 \u5bf9\u4e8e COVID-19 \u7684 POCT\uff0c\u4e3b\u7ba1\u90e8\u95e8\u53ef\u4ee5\u8003\u8651\u54ea\u4e9b\u5177\u6709\u5e94\u7528\u524d\u666f\u7684\u68c0\u6d4b\u65b9\u6cd5\uff1f \u4efb\u4f55\u5728\u7b2c 3 \u7ea7\u4e2d\u83b7\u5f97\u5ba2\u89c2\u9ad8\u8868\u73b0\u786e\u8ba4\u7684\u68c0\u6d4b\uff0c\u90fd\u5728\u5f53\u524d\u75ab\u60c5\u53ca\u672a\u6765\u65b0\u53d1\u75ab\u60c5\u7684\u7ba1\u7406\u4e2d\u5177\u6709\u6781\u9ad8\u7684\u5e94\u7528\u524d\u666f\u3002\u5176\u4e2d\u5305\u62ec\u7528\u4e8e SARS-CoV-2 \u521d\u59cb\u68c0\u6d4b\u7684\u5206\u5b50\u8bca\u65ad\u6d4b\u8bd5\uff0c\u4ee5\u53ca\u7528\u4e8e\u8bc4\u4f30\u611f\u67d3\u6216\u63a5\u79cd\u75ab\u82d7\u540e\u514d\u75ab\u53cd\u5e94\u7684\u6297\u4f53\u68c0\u6d4b\u3002\u4f9d\u636e\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u7d27\u6025\u4f7f\u7528\u6388\u6743 \u6279\u51c6\u7684\u68c0\u6d4b\u5217\u4e8e\u53c2\u8003\u6587\u732e 10\u3002 \u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u5e02\u573a\u4e0a\u7684\u8bb8\u591a\u68c0\u6d4b\u90fd\u8868\u73b0\u4e0d\u4f73\u3002POCT \u4e0d\u5e94\u6210\u4e3a\u68c0\u6d4b\u6709\u8bef\u7684\u7406\u7531\u3002\u5728\u5c06 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