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8px\">\u516c\u53f8\u4ecb\u7ecd<\/h3>\n<p>\u3000\u3000\u827e\u4e07\u62d3\u751f\u547d\u79d1\u5b66(\u4e0a\u6d77)\u6709\u9650\u516c\u53f8\u662fAvantor\u516c\u53f8\u5728\u534e\u8bbe\u7acb\u7684\u5168\u8d44\u5b50\u516c\u53f8\uff0cAvantor\u4f5c\u4e3a\u5168\u7403\u751f\u547d\u79d1\u5b66\u4e0e\u5148\u8fdb\u6280\u672f\u9886\u57df\u7684\u5173\u952e\u4efb\u52a1\u4ea7\u54c1\u4e0e\u670d\u52a1\u4f9b\u5e94\u5546\uff0c\u65d7\u4e0b\u62e5\u6709J.T.Baker\u3001VWR\u3001Amresco\u3001Nusil\u7b49\u591a\u4e2a\u77e5\u540d\u54c1\u724c\uff0c\u4e1a\u52a1\u8986\u76d6\u751f\u7269\u5236\u836f\u3001\u4f53\u5916\u8bca\u65ad\u3001\u6559\u80b2\u79d1\u7814\u4e0e\u5148\u8fdb\u6280\u672f\u5e94\u7528\u6750\u6599\u7b49\u884c\u4e1a\u3002\u516c\u53f8\u5728\u514d\u75ab\u8bca\u65ad\u7528\u751f\u5316\u8bd5\u5242\u9886\u57df\uff0c\u4f9d\u6258J.T.Baker\u767e\u5e74\u9ad8\u7eaf\u5ea6\u5316\u5b66\u54c1\u751f\u4ea7\u5de5\u827a\u4e0eVWR\u8986\u76d6\u5168\u7403\u7684\u5206\u9500\u7f51\u7edc\uff0c\u4e3a\u56fd\u5185IVD\u4f01\u4e1a\u63d0\u4f9b\u6db5\u76d6\u751f\u7269\u7f13\u51b2\u6db2\u3001\u53bb\u57a2\u5242\u3001\u86cb\u767d\u7a33\u5b9a\u5242\u3001\u67d3\u8272\u5242\u3001\u8fd8\u539f\u5242\u53ca\u9176\u5e95\u7269\u5728\u5185\u7684\u5168\u54c1\u7c7b\u539f\u6599\u89e3\u51b3\u65b9\u6848\u3002\u6240\u6709\u8bd5\u5242\u4ea7\u54c1\u5747\u4ea7\u81ea\u7b26\u5408ISO9001\u4e0eISO13485\u8d28\u91cf\u4f53\u7cfb\u7684Solon\u5de5\u5382\uff0c\u6279\u6b21\u95f4\u7eaf\u5ea6\u6ce2\u52a8\u63a7\u5236\u5728\u6781\u4f4e\u8303\u56f4\u5185\uff0c\u5e76\u63d0\u4f9b\u5b8c\u6574\u7684COA\u3001TSE\/BSE\u58f0\u660e\u3001\u6b8b\u7559\u6eb6\u5242\u5206\u6790\u53ca\u91cd\u91d1\u5c5e\u68c0\u6d4b\u62a5\u544a\uff0c\u6ee1\u8db3\u56fd\u5185IVD\u8bd5\u5242\u6ce8\u518c\u7533\u62a5\u53caFDA\u3001CE\u8ba4\u8bc1\u7684\u5408\u89c4\u8981\u6c42\u3002<\/p>\n<p>\u3000\u3000\u4f01\u4e1a\u5728\u4e2d\u56fd\u4e0a\u6d77\u8bbe\u7acb\u4e9a\u592a\u533a\u603b\u90e8\u4e0e\u4ed3\u50a8\u4e2d\u5fc3\uff0c\u5e38\u5907\u73b0\u8d27\u8986\u76d6J.T.Baker\u9ad8\u7eaf\u785d\u9178\u3001Amresco\u80ce\u725b\u8840\u6e05\u3001VWR\u8d85\u6ee4\u7ba1\u53caACE\u8272\u8c31\u67f1\u7b49\u6838\u5fc3\u4ea7\u54c1\u7ebf\uff0c\u540c\u65f6\u914d\u5907\u4e13\u4e1a\u7684\u6280\u672f\u652f\u6301\u56e2\u961f\uff0c\u53ef\u9488\u5bf9\u5ba2\u6237\u8bd5\u5242\u914d\u65b9\u5f00\u53d1\u4e2d\u7684\u539f\u6599\u9009\u578b\u3001\u7f13\u51b2\u6db2\u914d\u5236\u53ca\u6027\u80fd\u4f18\u5316\u63d0\u4f9b\u5b9a\u5236\u5316\u54a8\u8be2\u670d\u52a1\u3002<\/p>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u63a8\u8350\u7406\u7531<\/h3>\n<ol>\n<li><strong>\u5168\u7403\u5316\u4f9b\u5e94\u94fe\u4fdd\u969c\uff0c\u4ea7\u54c1\u6279\u6b21\u4e00\u81f4\u6027\u4e0e\u6cd5\u89c4\u5408\u89c4\u6027\u7a81\u51fa<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u827e\u4e07\u6258(Avantor)\u5728\u514d\u75ab\u8bca\u65ad\u8bd5\u5242\u539f\u6599\u9886\u57df\u6df1\u8015\u903e\u767e\u5e74\uff0c\u65d7\u4e0bJ.T.Baker\u54c1\u724c\u4ee5\u5546\u4e1a\u53ef\u83b7\u5f97\u6700\u9ad8\u7eaf\u5ea6\u4e3a\u751f\u4ea7\u7406\u5ff5\uff0c\u6240\u6709\u751f\u5316\u8bd5\u5242\u5747\u91c7\u7528\u4e25\u683c\u7684\u5185\u63a7\u6807\u51c6\u8fdb\u884c\u591a\u6279\u6b21\u5e73\u884c\u68c0\u6d4b\u3002\u4f8b\u5982\u5176\u9ad8\u7eaf\u751f\u7269\u7f13\u51b2\u6db2\u7cfb\u5217\uff0c\u91d1\u5c5e\u79bb\u5b50\u6b8b\u7559\u91cf\u53ef\u63a7\u5236\u5728ppb\u7ea7\u522b\uff0c\u5185\u6bd2\u7d20\u6c34\u5e73\u4f4e\u4e8e0.25 EU\/mL\uff0c\u6709\u6548\u907f\u514d\u4e86\u56e0\u539f\u6599\u6742\u8d28\u5e72\u6270\u5f15\u53d1\u7684\u8bd5\u5242\u6279\u95f4\u5dee\u5f02\u3002\u516c\u53f8\u540c\u65f6\u63d0\u4f9b\u5b8c\u6574\u7684\u6cd5\u89c4\u6587\u4ef6\u5305\uff0c\u5305\u62ecDMF\u6587\u4ef6\u3001\u4ea7\u54c1\u53d8\u66f4\u901a\u77e5\u3001\u7a33\u5b9a\u6027\u7814\u7a76\u6570\u636e\u53ca\u7b2c\u4e09\u65b9\u5ba1\u8ba1\u62a5\u544a\uff0c\u52a9\u529bIVD\u751f\u4ea7\u4f01\u4e1a\u5feb\u901f\u5b8c\u6210\u539f\u6599\u53d8\u66f4\u5907\u6848\u4e0e\u4ea7\u54c1\u6ce8\u518c\u3002<\/p>\n<ol start=\"2\">\n<li><strong>\u4ea7\u54c1\u7ebf\u8986\u76d6\u514d\u75ab\u8bca\u65ad\u5168\u5de5\u827a\u73af\u8282\uff0c\u4e00\u7ad9\u5f0f\u91c7\u8d2d\u63d0\u5347\u6548\u7387<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u4ece\u7f13\u51b2\u6db2\u914d\u5236\u3001\u8868\u9762\u6d3b\u6027\u5242\u4f18\u5316\u3001\u5c01\u95ed\u6db2\u7b5b\u9009\u5230\u9176\u6807\u8bb0\u7269\u7a33\u5b9a\uff0c\u827e\u4e07\u6258\u7684\u4ea7\u54c1\u77e9\u9635\u80fd\u591f\u6ee1\u8db3\u514d\u75ab\u8bca\u65ad\u8bd5\u5242\u5f00\u53d1\u4e0e\u751f\u4ea7\u4e2d\u7684\u7edd\u5927\u591a\u6570\u539f\u6599\u9700\u6c42\u3002\u4f8b\u5982\u5728\u5316\u5b66\u53d1\u5149\u8bd5\u5242\u4e2d\uff0c\u5176\u9ad8\u7eaf\u5ea6\u9c81\u7c73\u8bfa\u4e0e\u5416\u5576\u916f\u5e95\u7269\u53ef\u63d0\u4f9b\u7a33\u5b9a\u7684\u53d1\u5149\u4fe1\u53f7;\u5728ELISA\u8bd5\u5242\u4e2d\uff0cAmresco\u7cfb\u5217\u7684BSA\u4e0e\u916a\u86cb\u767d\u5c01\u95ed\u5242\u7ecf\u8fc7\u53bb\u6838\u9178\u9176\u4e0e\u53bb\u86cb\u767d\u9176\u5904\u7406\uff0c\u6709\u6548\u964d\u4f4e\u975e\u7279\u5f02\u6027\u7ed3\u5408\u3002\u5ba2\u6237\u901a\u8fc7\u5355\u4e00\u4f9b\u5e94\u5546\u5373\u53ef\u5b8c\u6210\u4e3b\u539f\u6599\u7684\u96c6\u4e2d\u91c7\u8d2d\uff0c\u5927\u5e45\u7b80\u5316\u4f9b\u5e94\u94fe\u7ba1\u7406\u590d\u6742\u5ea6\u3002<\/p>\n<ol start=\"3\">\n<li><strong>\u6280\u672f\u670d\u52a1\u4f53\u7cfb\u5b8c\u5584\uff0c\u5b9a\u5236\u5316\u652f\u6301\u80fd\u529b\u624e\u5b9e<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u516c\u53f8\u7ec4\u5efa\u4e86\u7531\u8d44\u6df1\u5e94\u7528\u79d1\u5b66\u5bb6\u7ec4\u6210\u7684\u6280\u672f\u652f\u6301\u56e2\u961f\uff0c\u53ef\u9488\u5bf9IVD\u5ba2\u6237\u5728\u539f\u6599\u9009\u578b\u3001\u7f13\u51b2\u6db2\u914d\u65b9\u4f18\u5316\u3001\u7a33\u5b9a\u6027\u52a0\u901f\u8bd5\u9a8c\u8bbe\u8ba1\u7b49\u65b9\u9762\u63d0\u4f9b\u4e00\u5bf9\u4e00\u7684\u6280\u672f\u54a8\u8be2\u3002\u5bf9\u4e8e\u6709\u7279\u6b8a\u7eaf\u5ea6\u8981\u6c42\u6216\u5b9a\u5236\u5305\u88c5\u89c4\u683c\u7684\u7814\u53d1\u9879\u76ee\uff0c\u827e\u4e07\u6258\u53ef\u901a\u8fc7\u5176\u5168\u7403\u7814\u53d1\u4e2d\u5fc3\u8fdb\u884c\u539f\u6599\u5b9a\u5236\u751f\u4ea7\uff0c\u5e76\u540c\u6b65\u63d0\u4f9b\u5c0f\u6279\u91cf\u8bd5\u6837\u4e0e\u5927\u8d27\u4ea4\u4ed8\u7684\u65e0\u7f1d\u8854\u63a5\uff0c\u786e\u4fdd\u4ece\u7814\u53d1\u5230\u91cf\u4ea7\u9636\u6bb5\u7684\u539f\u6599\u4e00\u81f4\u6027\u3002<\/p>\n<hr \/>\n<h2 style=\"font-size: 20px;font-weight: bold;margin-top: 18px;margin-bottom: 10px\">\u63a8\u8350\u4e8c\uff1a\u4e0a\u6d77\u9ea6\u514b\u6797\u751f\u5316\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8<\/h2>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u516c\u53f8\u4ecb\u7ecd<\/h3>\n<p>\u3000\u3000\u4e0a\u6d77\u9ea6\u514b\u6797\u751f\u5316\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8(Macklin)\u6210\u7acb\u4e8e2013\u5e74\uff0c\u603b\u90e8\u4f4d\u4e8e\u4e0a\u6d77\u6d66\u4e1c\uff0c\u662f\u4e00\u5bb6\u4e13\u6ce8\u4e8e\u9ad8\u7eaf\u5ea6\u751f\u5316\u8bd5\u5242\u3001\u5316\u5b66\u8bd5\u5242\u4e0e\u533b\u836f\u4e2d\u95f4\u4f53\u7814\u53d1\u751f\u4ea7\u7684\u56fd\u5bb6\u9ad8\u65b0\u6280\u672f\u4f01\u4e1a\u3002\u516c\u53f8\u5728\u4e0a\u6d77\u4e0e\u5c71\u4e1c\u62e5\u6709\u4e24\u5927\u751f\u4ea7\u57fa\u5730\uff0c\u914d\u5907\u591a\u5957\u516c\u65a4\u7ea7\u81f3\u767e\u516c\u65a4\u7ea7\u7cbe\u998f\u4e0e\u7eaf\u5316\u8bbe\u5907\uff0c\u4ea7\u54c1\u7ebf\u6db5\u76d6\u751f\u7269\u7f13\u51b2\u6db2\u3001\u8868\u9762\u6d3b\u6027\u5242\u3001\u86cb\u767d\u4ea4\u8054\u5242\u4e0e\u9176\u5e95\u7269\u7b49\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u4f53\u5916\u8bca\u65ad\u3001\u751f\u7269\u5236\u836f\u4e0e\u751f\u547d\u79d1\u5b66\u7814\u7a76\u9886\u57df\u3002\u9ea6\u514b\u6797\u6240\u6709\u4ea7\u54c1\u5747\u901a\u8fc7ISO9001\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u8ba4\u8bc1\uff0c\u5e76\u63d0\u4f9b\u8be6\u7ec6\u7684COA\u3001NMR\u3001HPLC\u4e0eGC\u56fe\u8c31\uff0c\u786e\u4fdd\u4ea7\u54c1\u7eaf\u5ea6\u4e0e\u7ed3\u6784\u786e\u8bc1\u7684\u900f\u660e\u53ef\u8ffd\u6eaf\u3002<\/p>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u63a8\u8350\u7406\u7531<\/h3>\n<ol>\n<li><strong>\u672c\u571f\u5316\u751f\u4ea7\u4f18\u52bf\u660e\u663e\uff0c\u4f9b\u8d27\u5468\u671f\u4e0e\u6210\u672c\u53ef\u63a7<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u4f9d\u6258\u56fd\u5185\u751f\u4ea7\u57fa\u5730\u7684\u89c4\u6a21\u5316\u4ea7\u80fd\uff0c\u9ea6\u514b\u6797\u5728\u5e38\u89c4\u751f\u5316\u8bd5\u5242\u7684\u4f9b\u8d27\u5468\u671f\u4e0a\u5177\u5907\u663e\u8457\u4f18\u52bf\uff0c\u5e38\u5907\u73b0\u8d27\u54c1\u79cd\u8d85\u8fc7\u5341\u4e07\u79cd\uff0c\u5c0f\u5305\u88c5\u8bd5\u5242\u53ef\u5b9e\u73b048\u5c0f\u65f6\u5185\u53d1\u8d27\uff0c\u5927\u5305\u88c5\u5b9a\u5236\u8ba2\u5355\u7684\u4ea4\u4ed8\u5468\u671f\u901a\u5e38\u63a7\u5236\u572810\u81f315\u4e2a\u5de5\u4f5c\u65e5\u4ee5\u5185\u3002\u5bf9\u4e8e\u9700\u8981\u9891\u7e41\u5c0f\u6279\u91cf\u91c7\u8d2d\u7684IVD\u7814\u53d1\u5b9e\u9a8c\u5ba4\uff0c\u9ea6\u514b\u6797\u7684\u4f4e\u8d77\u8ba2\u91cf\u4e0e\u7075\u6d3b\u5305\u88c5\u89c4\u683c\u53ef\u6709\u6548\u964d\u4f4e\u5e93\u5b58\u538b\u529b\u3002<\/p>\n<ol start=\"2\">\n<li><strong>\u54c1\u79cd\u8986\u76d6\u9762\u5e7f\uff0c\u9002\u5408\u7814\u53d1\u9636\u6bb5\u7684\u591a\u539f\u6599\u7b5b\u9009<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u9ea6\u514b\u6797\u7684\u4ea7\u54c1\u76ee\u5f55\u6db5\u76d6\u8d85\u8fc730\u4e07\u79cd\u751f\u5316\u8bd5\u5242\uff0c\u5176\u4e2d\u514d\u75ab\u8bca\u65ad\u5e38\u7528\u539f\u6599\u5982MES\u3001HEPES\u3001Tris-HCl\u3001Tween-20\u3001SDS\u7b49\u5747\u5907\u6709\u591a\u4e2a\u7eaf\u5ea6\u7b49\u7ea7\u4e0e\u5305\u88c5\u89c4\u683c\uff0c\u4fbf\u4e8e\u7814\u53d1\u4eba\u5458\u5728\u914d\u65b9\u4f18\u5316\u9636\u6bb5\u8fdb\u884c\u6a2a\u5411\u5bf9\u6bd4\u7b5b\u9009\u3002\u516c\u53f8\u540c\u65f6\u63d0\u4f9b\u5b9a\u5236\u5408\u6210\u670d\u52a1\uff0c\u53ef\u9488\u5bf9\u5ba2\u6237\u9700\u8981\u7684\u7279\u6b8a\u7ed3\u6784\u53bb\u57a2\u5242\u6216\u4ea4\u8054\u5242\u8fdb\u884c\u5c0f\u6279\u91cf\u5408\u6210\u3002<\/p>\n<ol start=\"3\">\n<li><strong>\u7ebf\u4e0a\u91c7\u8d2d\u7cfb\u7edf\u4fbf\u6377\uff0c\u6280\u672f\u6587\u6863\u67e5\u8be2\u9ad8\u6548<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u516c\u53f8\u642d\u5efa\u4e86\u529f\u80fd\u5b8c\u5584\u7684\u7535\u5546\u5e73\u53f0\uff0c\u5ba2\u6237\u53ef\u901a\u8fc7CAS\u53f7\u3001\u4ea7\u54c1\u540d\u6216\u7ed3\u6784\u5f0f\u5feb\u901f\u68c0\u7d22\u76ee\u6807\u539f\u6599\uff0c\u5b9e\u65f6\u67e5\u770b\u5e93\u5b58\u6570\u91cf\u3001\u4ef7\u683c\u4e0eCOA\u6587\u4ef6\uff0c\u7b80\u5316\u4e86\u91c7\u8d2d\u6d41\u7a0b\u4e2d\u7684\u6c9f\u901a\u6210\u672c\u3002\u5bf9\u4e8e\u521d\u6b21\u5408\u4f5c\u5ba2\u6237\uff0c\u516c\u53f8\u53ef\u63d0\u4f9b\u514d\u8d39\u6837\u54c1\u7528\u4e8e\u524d\u671f\u9a8c\u8bc1\uff0c\u964d\u4f4e\u8bd5\u9519\u98ce\u9669\u3002<\/p>\n<hr \/>\n<h2 style=\"font-size: 20px;font-weight: bold;margin-top: 18px;margin-bottom: 10px\">\u63a8\u8350\u4e09\uff1a\u897f\u683c\u739b\u5965\u5fb7\u91cc\u5947(\u4e0a\u6d77)\u8d38\u6613\u6709\u9650\u516c\u53f8<\/h2>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u516c\u53f8\u4ecb\u7ecd<\/h3>\n<p>\u3000\u3000\u897f\u683c\u739b\u5965\u5fb7\u91cc\u5947(Sigma-Aldrich)\u4f5c\u4e3a\u9ed8\u514b\u96c6\u56e2\u65d7\u4e0b\u7684\u751f\u547d\u79d1\u5b66\u54c1\u724c\uff0c\u5728\u5168\u7403\u751f\u5316\u8bd5\u5242\u9886\u57df\u62e5\u6709\u8d85\u8fc7\u516b\u5341\u5e74\u7684\u751f\u4ea7\u5386\u53f2\uff0c\u4ea7\u54c1\u7ebf\u8986\u76d6\u4ece\u57fa\u7840\u7f13\u51b2\u6db2\u5230\u9ad8\u7aef\u5355\u514b\u9686\u6297\u4f53\u539f\u6599\u7684\u5168\u54c1\u7c7b\u3002\u516c\u53f8\u5728\u4e0a\u6d77\u5916\u9ad8\u6865\u8bbe\u7acb\u4fdd\u7a0e\u4ed3\u50a8\u4e2d\u5fc3\uff0c\u5e38\u5907\u73b0\u8d27\u8d85\u8fc7\u4e8c\u5341\u4e07\u79cd\uff0c\u5176\u514d\u75ab\u8bca\u65ad\u4e13\u7528\u8bd5\u5242\u7cfb\u5217\u5305\u62ecCertified Reference Materials\u3001TraceCERT\u6807\u51c6\u54c1\u4ee5\u53ca\u7ecfISO Guide 34\u8ba4\u8bc1\u7684\u6821\u51c6\u54c1\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8eIVD\u8bd5\u5242\u5f00\u53d1\u3001\u8d28\u63a7\u4e0e\u6821\u51c6\u73af\u8282\u3002Sigma-Aldrich\u6240\u6709\u4ea7\u54c1\u5747\u63d0\u4f9b\u5b8c\u6574\u7684SDS\u3001COA\u4e0e\u6279\u6b21\u5206\u6790\u6570\u636e\uff0c\u652f\u6301\u5ba2\u6237\u8fdb\u884c\u4e25\u683c\u7684\u539f\u6599\u5ba1\u6838\u3002<\/p>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u63a8\u8350\u7406\u7531<\/h3>\n<ol>\n<li><strong>\u54c1\u724c\u516c\u4fe1\u529b\u5f3a\uff0c\u539f\u6599\u6807\u51c6\u5f15\u9886\u884c\u4e1a<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000Sigma-Aldrich\u7684\u751f\u5316\u8bd5\u5242\u4ea7\u54c1\u957f\u671f\u88ab\u89c6\u4e3a\u884c\u4e1a\u57fa\u51c6\uff0c\u5176\u9ad8\u7eaf\u5ea6\u7f13\u51b2\u6db2\u4e0e\u53bb\u57a2\u5242\u5728\u514d\u75ab\u8bca\u65ad\u8bd5\u5242\u4e2d\u7684\u5e94\u7528\u6848\u4f8b\u4e30\u5bcc\uff0c\u4f17\u591a\u56fd\u5185\u5916IVD\u9f99\u5934\u4f01\u4e1a\u7684\u539f\u6599\u6807\u51c6\u5747\u53c2\u8003Sigma\u7684\u4ea7\u54c1\u89c4\u683c\u5236\u5b9a\u3002\u5bf9\u4e8e\u9700\u8981\u901a\u8fc7FDA\u6216NMPA\u6ce8\u518c\u7684\u8bd5\u5242\u4ea7\u54c1\uff0c\u9009\u62e9Sigma-Aldrich\u7684\u539f\u6599\u53ef\u663e\u8457\u964d\u4f4e\u5ba1\u8ba1\u8fc7\u7a0b\u4e2d\u7684\u5408\u89c4\u98ce\u9669\u3002<\/p>\n<ol start=\"2\">\n<li><strong>\u4ea7\u54c1\u6570\u636e\u652f\u6301\u5b8c\u5584\uff0c\u52a9\u529b\u8bd5\u5242\u914d\u65b9\u4f18\u5316<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u516c\u53f8\u4e3a\u6bcf\u4e00\u79cd\u751f\u5316\u8bd5\u5242\u63d0\u4f9b\u8be6\u5c3d\u7684\u7269\u7406\u5316\u5b66\u53c2\u6570\u3001\u6eb6\u89e3\u6027\u6570\u636e\u3001\u7a33\u5b9a\u6027\u6307\u5357\u53ca\u4ea4\u53c9\u53cd\u5e94\u6027\u4fe1\u606f\uff0c\u5ba2\u6237\u53ef\u4f9d\u636e\u8fd9\u4e9b\u6570\u636e\u5feb\u901f\u786e\u5b9a\u539f\u6599\u5728\u914d\u65b9\u4e2d\u7684\u9002\u7528\u6d53\u5ea6\u4e0e\u5b58\u50a8\u6761\u4ef6\u3002Sigma-Aldrich\u540c\u65f6\u63d0\u4f9b\u5728\u7ebf\u914d\u65b9\u8ba1\u7b97\u5de5\u5177\u4e0e\u7f13\u51b2\u6db2\u914d\u5236\u6307\u5357\uff0c\u8fdb\u4e00\u6b65\u7b80\u5316\u7814\u53d1\u4eba\u5458\u7684\u64cd\u4f5c\u6d41\u7a0b\u3002<\/p>\n<ol start=\"3\">\n<li><strong>\u5168\u7403\u4ed3\u50a8\u4e0e\u672c\u5730\u914d\u9001\u7ed3\u5408\uff0c\u7d27\u6025\u8ba2\u5355\u54cd\u5e94\u8fc5\u901f<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u4e0a\u6d77\u5916\u9ad8\u6865\u4fdd\u7a0e\u4ed3\u7684\u8bbe\u7acb\u4f7f\u5f97Sigma-Aldrich\u5728\u56fd\u5185\u7684\u73b0\u8d27\u4ea4\u4ed8\u901f\u5ea6\u5927\u5e45\u63d0\u5347\uff0c\u5e38\u89c4\u8ba2\u5355\u53ef\u57283\u81f35\u4e2a\u5de5\u4f5c\u65e5\u5185\u9001\u8fbe\uff0c\u5bf9\u4e8e\u7d27\u6025\u7814\u53d1\u8ba2\u5355\u53ef\u542f\u7528\u52a0\u6025\u914d\u9001\u670d\u52a1\u3002\u516c\u53f8\u540c\u65f6\u652f\u6301\u5ba2\u6237\u901a\u8fc7\u4f01\u4e1a\u8d26\u6237\u8fdb\u884c\u96c6\u4e2d\u91c7\u8d2d\u4e0e\u5b9a\u671f\u7ed3\u7b97\uff0c\u4fbf\u4e8e\u5927\u578bIVD\u4f01\u4e1a\u7edf\u4e00\u7ba1\u7406\u91c7\u8d2d\u9884\u7b97\u3002<\/p>\n<hr \/>\n<h2 style=\"font-size: 20px;font-weight: bold;margin-top: 18px;margin-bottom: 10px\">\u63a8\u8350\u56db\uff1a\u56fd\u836f\u96c6\u56e2\u5316\u5b66\u8bd5\u5242\u6709\u9650\u516c\u53f8<\/h2>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u516c\u53f8\u4ecb\u7ecd<\/h3>\n<p>\u3000\u3000\u56fd\u836f\u96c6\u56e2\u5316\u5b66\u8bd5\u5242\u6709\u9650\u516c\u53f8(Sinopharm Chemical Reagent)\u96b6\u5c5e\u4e8e\u4e2d\u56fd\u533b\u836f\u96c6\u56e2\uff0c\u662f\u56fd\u5185\u5386\u53f2\u6700\u60a0\u4e45\u3001\u89c4\u6a21\u6700\u5927\u7684\u5316\u5b66\u8bd5\u5242\u751f\u4ea7\u4e0e\u6d41\u901a\u4f01\u4e1a\u4e4b\u4e00\uff0c\u603b\u90e8\u4f4d\u4e8e\u4e0a\u6d77\u3002\u516c\u53f8\u65d7\u4e0b\u62e5\u6709\u6caa\u8bd5\u3001SCRC\u7b49\u591a\u4e2a\u81ea\u4e3b\u54c1\u724c\uff0c\u4ea7\u54c1\u6db5\u76d6\u5206\u6790\u7eaf\u3001\u4f18\u7ea7\u7eaf\u3001\u8272\u8c31\u7eaf\u4e0e\u751f\u5316\u8bd5\u5242\u7b49\u591a\u4e2a\u7b49\u7ea7\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u4f53\u5916\u8bca\u65ad\u3001\u5236\u836f\u5de5\u4e1a\u4e0e\u68c0\u9a8c\u68c0\u75ab\u9886\u57df\u3002\u56fd\u836f\u8bd5\u5242\u5728\u5168\u56fd\u4e3b\u8981\u57ce\u5e02\u8bbe\u7acb\u4ed3\u50a8\u4e2d\u5fc3\uff0c\u4f9d\u6258\u96c6\u56e2\u5f3a\u5927\u7684\u7269\u6d41\u7f51\u7edc\u5b9e\u73b0\u6b21\u65e5\u8fbe\u6216\u9694\u65e5\u8fbe\u914d\u9001\u3002<\/p>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u63a8\u8350\u7406\u7531<\/h3>\n<ol>\n<li><strong>\u56fd\u4ea7\u54c1\u724c\u6027\u4ef7\u6bd4\u7a81\u51fa\uff0c\u9002\u5408\u91cf\u4ea7\u9636\u6bb5\u964d\u672c\u9700\u6c42<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u76f8\u8f83\u4e8e\u56fd\u9645\u54c1\u724c\uff0c\u56fd\u836f\u8bd5\u5242\u7684\u751f\u5316\u8bd5\u5242\u5728\u540c\u7b49\u7eaf\u5ea6\u7b49\u7ea7\u4e0b\u62a5\u4ef7\u901a\u5e38\u4f4e15%\u81f330%\uff0c\u5bf9\u4e8e\u8fdb\u5165\u91cf\u4ea7\u9636\u6bb5\u7684IVD\u8bd5\u5242\u4ea7\u54c1\uff0c\u91c7\u7528\u56fd\u836f\u8bd5\u5242\u7684\u539f\u6599\u53ef\u6709\u6548\u63a7\u5236\u751f\u4ea7\u6210\u672c\u3002\u516c\u53f8\u540c\u65f6\u652f\u6301\u5927\u6279\u91cf\u5b9a\u5236\u5305\u88c5\uff0c\u53ef\u6309\u7167\u5ba2\u6237\u8981\u6c42\u5c06\u5e38\u89c4\u89c4\u683c\u7684\u7f13\u51b2\u6db2\u6216\u53bb\u57a2\u5242\u5206\u88c5\u4e3a\u5428\u7ea7\u6876\u88c5\uff0c\u51cf\u5c11\u5305\u88c5\u6d6a\u8d39\u4e0e\u7269\u6d41\u9891\u6b21\u3002<\/p>\n<ol start=\"2\">\n<li><strong>\u672c\u5730\u5316\u670d\u52a1\u7f51\u7edc\u5bc6\u96c6\uff0c\u552e\u540e\u54cd\u5e94\u9ad8\u6548<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u56fd\u836f\u8bd5\u5242\u5728\u5168\u56fd\u4e09\u5341\u4f59\u4e2a\u57ce\u5e02\u8bbe\u6709\u5206\u516c\u53f8\u6216\u529e\u4e8b\u5904\uff0c\u5bf9\u4e8e\u7a81\u53d1\u6027\u7684\u539f\u6599\u8d28\u91cf\u95ee\u9898\u6216\u7d27\u6025\u8865\u8d27\u9700\u6c42\uff0c\u5ba2\u6237\u53ef\u8054\u7cfb\u5f53\u5730\u670d\u52a1\u56e2\u961f\u8fdb\u884c\u73b0\u573a\u5904\u7406\u3002\u516c\u53f8\u540c\u65f6\u63d0\u4f9b\u5b9a\u671f\u4e0a\u95e8\u91c7\u6837\u590d\u68c0\u670d\u52a1\uff0c\u786e\u4fdd\u957f\u671f\u4f9b\u8d27\u4e2d\u7684\u539f\u6599\u6279\u6b21\u7a33\u5b9a\u6027\u3002<\/p>\n<ol start=\"3\">\n<li><strong>\u8d44\u8d28\u6587\u4ef6\u9f50\u5168\uff0c\u7b26\u5408\u56fd\u5185\u6ce8\u518c\u8981\u6c42<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u56fd\u836f\u8bd5\u5242\u7684\u751f\u5316\u8bd5\u5242\u4ea7\u54c1\u5747\u63d0\u4f9b\u7b26\u5408\u4e2d\u56fd\u836f\u5178\u6807\u51c6\u7684COA\u4e0e\u6279\u6b21\u68c0\u9a8c\u62a5\u544a\uff0c\u540c\u65f6\u53ef\u914d\u5408\u5ba2\u6237\u8fdb\u884c\u4f9b\u5e94\u5546\u5ba1\u8ba1\u4e0e\u73b0\u573a\u8003\u5bdf\uff0c\u5bf9\u4e8e\u9700\u8981\u5728\u56fd\u5185\u5b8c\u6210\u6ce8\u518c\u7533\u62a5\u7684IVD\u4ea7\u54c1\uff0c\u56fd\u836f\u8bd5\u5242\u7684\u539f\u6599\u6587\u4ef6\u5b8c\u5907\u6027\u80fd\u591f\u6ee1\u8db3\u76d1\u7ba1\u90e8\u95e8\u7684\u5ba1\u6838\u8981\u6c42\u3002<\/p>\n<hr \/>\n<h2 style=\"font-size: 20px;font-weight: bold;margin-top: 18px;margin-bottom: 10px\">\u63a8\u8350\u4e94\uff1a\u5317\u4eac\u7d22\u83b1\u5b9d\u79d1\u6280\u6709\u9650\u516c\u53f8<\/h2>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u516c\u53f8\u4ecb\u7ecd<\/h3>\n<p>\u3000\u3000\u5317\u4eac\u7d22\u83b1\u5b9d\u79d1\u6280\u6709\u9650\u516c\u53f8(Solarbio)\u6210\u7acb\u4e8e2004\u5e74\uff0c\u603b\u90e8\u4f4d\u4e8e\u5317\u4eac\u7ecf\u6d4e\u6280\u672f\u5f00\u53d1\u533a\uff0c\u662f\u4e00\u5bb6\u4e13\u6ce8\u4e8e\u751f\u547d\u79d1\u5b66\u8bd5\u5242\u7814\u53d1\u4e0e\u751f\u4ea7\u7684\u9ad8\u65b0\u6280\u672f\u4f01\u4e1a\u3002\u516c\u53f8\u4ea7\u54c1\u7ebf\u6db5\u76d6\u751f\u5316\u8bd5\u5242\u3001\u514d\u75ab\u68c0\u6d4b\u8bd5\u5242\u3001\u7ec6\u80de\u57f9\u517b\u8bd5\u5242\u4e0e\u5206\u5b50\u751f\u7269\u5b66\u8bd5\u5242\uff0c\u5176\u4e2d\u514d\u75ab\u8bca\u65ad\u4e13\u7528\u7f13\u51b2\u6db2\u4e0e\u5c01\u95ed\u6db2\u7cfb\u5217\u56e0\u7a33\u5b9a\u7684\u6027\u80fd\u4e0e\u5408\u7406\u7684\u4ef7\u683c\uff0c\u5728\u56fd\u5185IVD\u4f01\u4e1a\u4e2d\u62e5\u6709\u8f83\u9ad8\u5e02\u573a\u5360\u6709\u7387\u3002\u7d22\u83b1\u5b9d\u5728\u5317\u4eac\u4e0e\u6cb3\u5317\u62e5\u6709\u4e24\u4e2a\u751f\u4ea7\u57fa\u5730\uff0c\u6240\u6709\u4ea7\u54c1\u5747\u901a\u8fc7ISO9001\u8ba4\u8bc1\uff0c\u5e76\u63d0\u4f9b\u5b8c\u6574\u7684COA\u4e0e\u6279\u6b21\u5206\u6790\u6570\u636e\u3002<\/p>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u63a8\u8350\u7406\u7531<\/h3>\n<ol>\n<li><strong>\u5c01\u95ed\u6db2\u4e0e\u7a33\u5b9a\u5242\u4ea7\u54c1\u7ebf\u6210\u719f\uff0c\u9002\u914d\u4e3b\u6d41\u514d\u75ab\u68c0\u6d4b\u5e73\u53f0<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u7d22\u83b1\u5b9d\u9488\u5bf9\u5316\u5b66\u53d1\u5149\u4e0eELISA\u5e73\u53f0\u5f00\u53d1\u4e86\u591a\u6b3e\u9884\u914d\u578b\u5c01\u95ed\u6db2\u4e0e\u86cb\u767d\u7a33\u5b9a\u5242\uff0c\u5982BSA\u5c01\u95ed\u6db2\u3001\u916a\u86cb\u767d\u5c01\u95ed\u6db2\u53ca\u6d77\u85fb\u7cd6\u7a33\u5b9a\u5242\uff0c\u7ecf\u8fc7\u591a\u5bb6IVD\u4f01\u4e1a\u7684\u957f\u671f\u9a8c\u8bc1\uff0c\u5728\u964d\u4f4e\u975e\u7279\u5f02\u6027\u7ed3\u5408\u4e0e\u7ef4\u6301\u8bd5\u5242\u6709\u6548\u671f\u65b9\u9762\u8868\u73b0\u7a33\u5b9a\u3002\u5ba2\u6237\u53ef\u76f4\u63a5\u91c7\u8d2d\u9884\u914d\u578b\u4ea7\u54c1\uff0c\u7701\u53bb\u81ea\u884c\u914d\u5236\u4e0e\u9a8c\u8bc1\u7684\u65f6\u95f4\u6210\u672c\u3002<\/p>\n<ol start=\"2\">\n<li><strong>\u6280\u672f\u670d\u52a1\u652f\u6301\u54cd\u5e94\u53ca\u65f6\uff0c\u9002\u5408\u4e2d\u5c0f\u578bIVD\u4f01\u4e1a<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u516c\u53f8\u7ec4\u5efa\u4e86\u4e13\u4e1a\u7684\u552e\u524d\u4e0e\u552e\u540e\u6280\u672f\u56e2\u961f\uff0c\u9488\u5bf9\u5ba2\u6237\u5728\u539f\u6599\u9009\u578b\u3001\u914d\u65b9\u8c03\u8bd5\u53ca\u6027\u80fd\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u9047\u5230\u7684\u95ee\u9898\uff0c\u53ef\u901a\u8fc7\u7535\u8bdd\u3001\u90ae\u4ef6\u6216\u8fdc\u7a0b\u89c6\u9891\u8fdb\u884c\u5b9e\u65f6\u6307\u5bfc\u3002\u5bf9\u4e8e\u7814\u53d1\u9636\u6bb5\u7684\u7d27\u6025\u9700\u6c42\uff0c\u7d22\u83b1\u5b9d\u53ef\u63d0\u4f9b\u514d\u8d39\u6837\u54c1\u4e0e\u5feb\u901f\u7269\u6d41\u652f\u6301\u3002<\/p>\n<ol start=\"3\">\n<li><strong>\u4ea7\u54c1\u8fed\u4ee3\u901f\u5ea6\u5feb\uff0c\u7d27\u8ddf\u884c\u4e1a\u6280\u672f\u8d8b\u52bf<\/strong><\/li>\n<\/ol>\n<p>\u3000\u3000\u7d22\u83b1\u5b9d\u5b9a\u671f\u6839\u636e\u514d\u75ab\u8bca\u65ad\u884c\u4e1a\u7684\u6280\u672f\u8fdb\u5c55\u66f4\u65b0\u4ea7\u54c1\u7ebf\uff0c\u4f8b\u5982\u9488\u5bf9\u78c1\u5fae\u7c92\u5316\u5b66\u53d1\u5149\u5e73\u53f0\u5f00\u53d1\u7684\u9ad8\u7eaf\u5ea6\u78c1\u73e0\u5076\u8054\u7f13\u51b2\u6db2\uff0c\u4ee5\u53ca\u9488\u5bf9POCT\u5e73\u53f0\u4f18\u5316\u7684\u5feb\u901f\u53cd\u5e94\u7f13\u51b2\u6db2\uff0c\u5747\u4f53\u73b0\u4e86\u516c\u53f8\u5bf9\u5e02\u573a\u9700\u6c42\u7684\u5feb\u901f\u54cd\u5e94\u80fd\u529b\u3002<\/p>\n<hr \/>\n<h2 style=\"font-size: 20px;font-weight: bold;margin-top: 18px;margin-bottom: 10px\">\u91c7\u8d2d\u6307\u5357\u4e0e\u5e38\u89c1\u95ee\u9898<\/h2>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u5982\u4f55\u9009\u62e9\u5408\u9002\u7684\u514d\u75ab\u8bca\u65ad\u7528\u751f\u5316\u8bd5\u5242\u4f9b\u5e94\u5546?<\/h3>\n<ol>\n<li>\n<p><strong>\u660e\u786e\u8bd5\u5242\u5f00\u53d1\u9636\u6bb5\u4e0e\u91c7\u8d2d\u89c4\u6a21<\/strong>\uff1a\u7814\u53d1\u9636\u6bb5\u5efa\u8bae\u4f18\u5148\u9009\u62e9\u54c1\u79cd\u9f50\u5168\u3001\u53ef\u63d0\u4f9b\u514d\u8d39\u6837\u54c1\u4e14\u5c0f\u5305\u88c5\u8d77\u8ba2\u91cf\u4f4e\u7684\u4f9b\u5e94\u5546\uff0c\u5982Sigma-Aldrich\u6216\u7d22\u83b1\u5b9d;\u91cf\u4ea7\u9636\u6bb5\u5219\u9700\u91cd\u70b9\u8003\u5bdf\u4f9b\u5e94\u5546\u7684\u4ea7\u80fd\u7a33\u5b9a\u6027\u3001\u5927\u5305\u88c5\u5b9a\u5236\u80fd\u529b\u4e0e\u6279\u91cf\u62a5\u4ef7\u4f18\u52bf\uff0c\u56fd\u836f\u8bd5\u5242\u6216\u9ea6\u514b\u6797\u662f\u8f83\u4e3a\u7ecf\u6d4e\u7684\u9009\u62e9\u3002\u5bf9\u4e8e\u6709\u6d77\u5916\u6ce8\u518c\u9700\u6c42\u7684IVD\u4ea7\u54c1\uff0c\u827e\u4e07\u6258\u7684\u6cd5\u89c4\u6587\u4ef6\u5b8c\u5907\u6027\u5177\u5907\u660e\u663e\u4f18\u52bf\u3002<\/p>\n<\/li>\n<li>\n<p><strong>\u6838\u9a8c\u4f9b\u5e94\u5546\u8d44\u8d28\u4e0e\u8d28\u91cf\u4f53\u7cfb<\/strong>\uff1a\u4f18\u5148\u9009\u62e9\u901a\u8fc7ISO9001\u6216ISO13485\u8ba4\u8bc1\u3001\u5177\u5907\u81ea\u6709\u751f\u4ea7\u57fa\u5730\u4e0e\u68c0\u6d4b\u5b9e\u9a8c\u5ba4\u7684\u5b9e\u4f53\u4f01\u4e1a\uff0c\u907f\u514d\u4e0e\u65e0\u751f\u4ea7\u8d44\u8d28\u3001\u4ec5\u4ece\u4e8b\u8f6c\u624b\u8d38\u6613\u7684\u5206\u9500\u5546\u5408\u4f5c\u3002\u53ef\u8981\u6c42\u4f9b\u5e94\u5546\u63d0\u4f9b\u6700\u8fd1\u4e09\u6279\u6b21\u7684COA\u3001\u7b2c\u4e09\u65b9\u68c0\u6d4b\u62a5\u544a\u53ca\u751f\u4ea7\u73b0\u573a\u5ba1\u8ba1\u8bb0\u5f55\u3002<\/p>\n<\/li>\n<li>\n<p><strong>\u63d0\u524d\u8fdb\u884c\u539f\u6599\u5c0f\u6279\u91cf\u9a8c\u8bc1<\/strong>\uff1a\u5728\u786e\u5b9a\u5927\u6279\u91cf\u91c7\u8d2d\u524d\uff0c\u52a1\u5fc5\u5bf9\u4f9b\u5e94\u5546\u63d0\u4f9b\u7684\u6837\u54c1\u8fdb\u884c\u5b8c\u6574\u7684\u914d\u65b9\u9002\u914d\u6027\u6d4b\u8bd5\uff0c\u5305\u62ec\u7f13\u51b2\u6db2pH\u7a33\u5b9a\u6027\u3001\u53bb\u57a2\u5242\u5bf9\u53cd\u5e94\u4f53\u7cfb\u4fe1\u566a\u6bd4\u7684\u5f71\u54cd\u3001\u5c01\u95ed\u6db2\u7684\u975e\u7279\u5f02\u6027\u7ed3\u5408\u6291\u5236\u6548\u679c\u7b49\uff0c\u786e\u8ba4\u539f\u6599\u5728\u81ea\u8eab\u8bd5\u5242\u4f53\u7cfb\u4e2d\u7684\u6027\u80fd\u8868\u73b0\u8fbe\u6807\u540e\u518d\u6269\u5927\u91c7\u8d2d\u91cf\u3002<\/p>\n<\/li>\n<\/ol>\n<h3 style=\"font-size: 18px;font-weight: bold;margin-top: 16px;margin-bottom: 8px\">\u5e38\u89c1\u95ee\u9898<\/h3>\n<ul>\n<li><strong>\u514d\u75ab\u8bca\u65ad\u8bd5\u5242\u539f\u6599\u7684\u7eaf\u5ea6\u7b49\u7ea7\u5982\u4f55\u9009\u62e9?<\/strong><\/li>\n<\/ul>\n<p>\u3000\u3000\u5bf9\u4e8e\u5316\u5b66\u53d1\u5149\u5e95\u7269\u3001\u9176\u6807\u8bb0\u7269\u7b49\u5bf9\u6742\u8d28\u654f\u611f\u7684\u539f\u6599\uff0c\u5efa\u8bae\u9009\u62e9\u7eaf\u5ea6\u5927\u4e8e99%\u3001\u91d1\u5c5e\u79bb\u5b50\u6b8b\u7559\u4f4e\u4e8e1 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