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\u00a0<\/div>\n
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\u00a0<\/div>\n
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\n![\"RmFicvQBAkgBXuxl8loXwicYg0KswuHZibaaQFMx5eCUS7awInPp4N4fxibfj2JDe7kVics83CgNIf8tOlLMZuHicnmA\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgBXuxl8loXwicYg0KswuHZibaaQFMx5eCUS7awInPp4N4fxibfj2JDe7kVics83CgNIf8tOlLMZuHicnmA.png\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n\u4e2d\u56fdLDT\u76d1\u7ba1\u653f\u7b56<\/div>\n
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\u4f5c\u4e3a\u9996\u4e2a\u63d0\u51fa\u5e76\u4f7f\u7528LDT\u8fd9\u4e2a\u6982\u5ff5\u7684\u56fd\u5bb6\uff0c\u7f8e\u56fd\u4e34\u5e8a\u75c5\u7406\u5b66\u4f1a\uff08American Society for Clinical Pathologists , ASCP\uff09\u660e\u786e\u5c06LDT\u5b9a\u4e49\u4e3a\u5b9e\u9a8c\u5ba4\u5185\u90e8\u7814\u53d1\u3001\u9a8c\u8bc1\u548c\u4f7f\u7528\uff0c\u91c7\u7528\u751f\u7269\u5316\u5b66\u3001\u7ec6\u80de\u9057\u4f20\u5b66\u3001\u5206\u5b50\u751f\u7269\u5b66\u8bd5\u9a8c\u65b9\u6cd5\uff0c\u4ee5\u8bca\u65ad\u4e3a\u76ee\u7684\uff0c\u5206\u6790DNA\u3001RNA\u3001\u7ebf\u7c92\u4f53\u3001\u86cb\u767d\u7ec4\u548c\u4ee3\u8c22\u7ec4\u75be\u75c5\u7b49\u751f\u7269\u6807\u5fd7\u7269\u7684\u4f53\u5916\u8bca\u65ad\u9879\u76ee\u3002<\/div>\n
\u00a0<\/div>\n
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\u00a0<\/div>\n
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\n![\"RmFicvQBAkgBXuxl8loXwicYg0KswuHZiba9UIKOzKN9oa9UgZm8jVIpKTL61micYPA9DPsC36rWmmELgdd2qN0rNQ\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgBXuxl8loXwicYg0KswuHZiba9UIKOzKN9oa9UgZm8jVIpKTL61micYPA9DPsC36rWmmELgdd2qN0rNQ.jpeg\")
<\/figure><\/div>\n\n
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\u00a0<\/div>\n
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\u00a0<\/div>\n
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\n![\"RmFicvQBAkgBXuxl8loXwicYg0KswuHZiba1XJMy9fiaQ2UxnC2ujhlP0J8v4m4z2VWnkNY335uFdPQkicpd970b3eA\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgBXuxl8loXwicYg0KswuHZiba1XJMy9fiaQ2UxnC2ujhlP0J8v4m4z2VWnkNY335uFdPQkicpd970b3eA.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n<\/div>\n\n
\n![\"RmFicvQBAkgBXuxl8loXwicYg0KswuHZibaoqxF5q1qNPXnjclpSwfpZRnfmOMsow8zXVA47X3V3EL3icYicmpiceQBA\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgBXuxl8loXwicYg0KswuHZibaoqxF5q1qNPXnjclpSwfpZRnfmOMsow8zXVA47X3V3EL3icYicmpiceQBA.jpeg\")
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\n![\"RmFicvQBAkgBXuxl8loXwicYg0KswuHZibabyiaviaHN8ziaNdtpNOaoUVyJGQEZ4NYw7akBZmxoKgAia4s7RwTEmmA9g\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgBXuxl8loXwicYg0KswuHZibabyiaviaHN8ziaNdtpNOaoUVyJGQEZ4NYw7akBZmxoKgAia4s7RwTEmmA9g.jpeg\")
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<\/figure><\/div>\n\n\n![\"RmFicvQBAkgBXuxl8loXwicYg0KswuHZibaBX8971LZhepdEAuwSOdN9LZSYrn9FiaX7jNDdvAyu4icG7fxkiaazAibcQ\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgBXuxl8loXwicYg0KswuHZibaBX8971LZhepdEAuwSOdN9LZSYrn9FiaX7jNDdvAyu4icG7fxkiaazAibcQ.jpeg\")
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<\/figure><\/div>\n\n\u5728\u6b64\u80cc\u666f\u4e0b\uff0c\u4e3a\u52a0\u5feb\u63a8\u8fdbLDT\u5e94\u7528\u4e8e\u7f55\u89c1\u75c5\u3001\u80bf\u7624\u7b49\u533b\u7597\u9886\u57df\u4e34\u5e8a\u670d\u52a1\uff0c\u57fa\u56e0\u6167\u4e0e\u9057\u4f20\u54a8\u8be2\u65b0\u9510\u4f01\u4e1a\u5408\u56e0\u79d1\u6280\u5728\u4e2d\u56fd\u9057\u4f20\u5b66\u4f1a\u9057\u4f20\u8bca\u65ad\u5206\u4f1a\u7684\u6307\u5bfc\u4e0b\uff0c\u643a\u624b\u4e3e\u529e\u201c\u751f\u547d\u4e4b\u58f0\u201d\u2014\u2014\u9057\u4f20\u53ca\u751f\u547d\u5065\u5eb7\u79d1\u6280\u63a8\u5e7f\u7cfb\u5217\u6d3b\u52a8\uff0c\u5f62\u5f0f\u591a\u6837\uff0c\u5305\u62ec\uff1a<\/div>\n
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1\u573a\u9057\u4f20\u53ca\u751f\u547d\u5065\u5eb7\u5e74\u4f1a<\/div>\n
1\u672c\u9057\u4f20\u84dd\u76ae\u4e66<\/div>\n
1\u4efd\u4e13\u5bb6\u56e2\u4f53\u5171\u8bc6<\/div>\n
\u00a0<\/div>\n
\u8bda\u9080LDT\u53ca\u76f8\u5173\u4f01\u4e1a\/\u673a\u6784\u53c2\u4e0e\u627f\u529e\u53ca\u8d5e\u52a9\uff0c\u5171\u540c\u63a2\u8ba8LDT\u5e94\u7528\u4e8e\u4e34\u5e8a\u670d\u52a1\u7684\u91cd\u96be\u70b9\u53ca\u5176\u672a\u6765\u53d1\u5c55\uff0c\u4fc3\u8fdb\u79d1\u7814\u6210\u679c\u5411\u4e34\u5e8a\u5e94\u7528\u7684\u8f6c\u5316\u548c\u5b9e\u8df5\u3002<\/div>\n
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[1]\u5168\u56fd\u4eba\u5927\u4ee3\u8868\u8521\u536b\u5e73\uff1a\u6709\u6761\u4ef6\u5141\u8bb8\u7b2c\u4e09\u65b9\u533b\u5b66\u68c0\u9a8c\u673a\u6784\u5f00\u5c55LDT\u9879\u76ee\u670d\u52a1\u4e8e\u4e34\u5e8a. \u4e2d\u56fd\u7ecf\u8425\u62a5.<\/div>\n
[2]\u4eca\u5e74\u5168\u56fd\u4e24\u4f1a\u4e0a\uff0c\u9648\u8d5b\u5a1f\u59d4\u5458\u8fd9\u6837\u8bf4. \u6f8e\u6e43\u65b0\u95fb.\u00a0<\/div>\n
[3]Regulation of Laboratory Developed Tests (LDTs). American Society for Clinical Pathologists.\u00a0<\/div>\n
[4]The Role of Lab-Developed Tests in the In Vitro Diagnostics Market.\u00a0Pewtrusts<\/div>\n
[5]\u738b\u5bc5, \u674e\u537f, \u738b\u96ea\u4eae, \u7b49. \u4e0a\u6d77\u5e02\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u81ea\u5efa\u68c0\u6d4b\u65b9\u6cd5\u7684\u5e02\u573a\u9700\u6c42\u548c\u653f\u5e9c\u76d1\u7ba1\u653f\u7b56\u5efa\u8bae. \u4e2d\u56fd\u536b\u751f\u8d44\u6e90, 2020, 23(4): 427-431. DOI: 10.13688\/j.cnki.chr.2020.20346<\/div>\n
[6]\u6c99\u5229\u6587, \u75bc\u75db\u6311\u6218\u57fa\u91d1\u4f1a. 2022\u4e2d\u56fd\u7f55\u89c1\u75c5\u884c\u4e1a\u8d8b\u52bf\u89c2\u5bdf\u62a5\u544a<\/div>\n
\u00a0<\/div>\n
\u4f5c\u8005\u4e28Kathy\u00a0\u7f16\u8f91\u4e28Kathy<\/div>\n
\u6821\u5bf9 | Mark\u00a0\u5ba1\u6838\u00a0| Mark\u00a0\u00a0<\/div>\n
\u9996\u53d1\u4e28\u57fa\u56e0\u6167\u00a0\u00a0\u5173\u952e\u8bcd | LDT\uff1b\u751f\u547d\u4e4b\u58f0\u6d3b\u52a8<\/div>\n\n
\n![\"RmFicvQBAkgArd371ayccZ0h7b1kYMcLjfOJjqyYaicggtUOt4GZejHKvHdYRhPW7uQicuY0VUdyFt2hQoYekWYjA\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgArd371ayccZ0h7b1kYMcLjfOJjqyYaicggtUOt4GZejHKvHdYRhPW7uQicuY0VUdyFt2hQoYekWYjA.png\")
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