\u00a0<\/div>\n
\u6587\u7ae0 | \u83c1\u826f\u57fa\u56e0<\/div>\n
\u7f16\u8f91 | \u9f50\u827a\u840c \u5173\u952e\u8bcd |\u00a0\u4ea7\u4e1a\u6280\u672f<\/div>\n
\u00a0<\/div>\n
\u4e00\u3001\u6807\u51c6\u7269\u8d28\uff08\u8d28\u63a7\u54c1\uff09\u7684\u6765\u6e90\u4e0e\u57fa\u672c\u6761\u4ef6<\/div>\n
\u5206\u5b50\u5b9e\u9a8c\u5ba4\u4e2d\uff0c\u4e00\u822c\u5c06\u6807\u51c6\u7269\u8d28\u5206\u6210\u4e24\u7c7b\uff1a<\/div>\n
1\u3001\u7528\u4e8e\u4eea\u5668\u6821\u51c6\u3001\u9a8c\u8bc1\u3001\u6d4b\u8bd5\u548c\u7ed8\u5236\u5de5\u4f5c\u6807\u51c6\u66f2\u7ebf\u7b49\u76ee\u7684\u7684\u6807\u51c6\u7269\u8d28\uff08\u4e00\u822c\u662f\u7531\u5382\u5546\u63d0\u4f9b\u7684\u8d28\u63a7\u54c1\uff09\uff1b<\/div>\n
2\u3001\u7528\u4e8e\u5916\u90e8\u5ba4\u95f4\u8d28\u8bc4\u3001\u5185\u90e8\u5ba4\u5185\u8d28\u63a7\u3001\u65b9\u6cd5\u9a8c\u8bc1\u7b49\u76ee\u7684\u7684\u6807\u51c6\u7269\u8d28\u3002<\/div>\n
\u00a0<\/div>\n
\u5728\u300a2021\u4e34\u5e8a\u533b\u5b66\u68c0\u9a8c\u6280\u672f\uff08\u58eb\uff09\u300b\u4e2d\uff0c\u7b2c\u4e8c\u7c7b\u6807\u51c6\u7269\u8d28\u53c8\u5206\u4e3a\u6807\u51c6\u54c1\u548c\u8d28\u63a7\u54c1\u4e24\u7c7b\uff08\u4e00\u822c\u4e3a\u7b2c\u4e09\u65b9\u63d0\u4f9b\u7684\u6807\u51c6\u54c1\u3001\u5b9e\u9a8c\u5ba4\u81ea\u5236\u8d28\u63a7\u54c1\uff09\u3002\u6839\u636eGB\/T 20468-2006\u300a\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u5b9a\u91cf\u6d4b\u5b9a\u5ba4\u5185\u8d28\u91cf\u63a7\u5236\u6307\u5357\u300b\uff0c\u5bf9\u4e8e\u8fd9\u7c7b\u6807\u51c6\u7269\u8d28\u7684\u8981\u6c42\u5171\u5206\u4e3a\u516d\u4e2a\u65b9\u9762\uff1a<\/div>\n
\u00a0<\/div>\n
\u2460\u00a0\u57fa\u8d28\uff1a\u5e94\u5c3d\u53ef\u80fd\u4e0e\u4e34\u5e8a\u6837\u672c\u7684\u57fa\u8d28\u76f8\u4f3c\u6216\u4e00\u6837\uff0c\u4e0d\u540c\u57fa\u8d28\u4e2d\u53ef\u80fd\u542b\u6709\u4e0d\u5b8c\u5168\u4e00\u81f4\u7684\u57fa\u56e0\u6269\u589e\u68c0\u6d4b\u6291\u5236\u7269\uff0c\u5e94\u5bf9\u6d4b\u5b9a\u7ed3\u679c\u65e0\u5f71\u54cd\uff1b<\/div>\n
\u2461\u00a0\u6d53\u5ea6\uff1a\u5728\u6d4b\u5b9a\u8303\u56f4\u5185\uff0c\u8d28\u63a7\u54c1\u8981\u6c42\u5176\u6240\u542b\u5f85\u6d4b\u7269\u7684\u6d53\u5ea6\u5c3d\u53ef\u80fd\u63a5\u8fd1\u8bd5\u9a8c\u6216\u4e34\u5e8a\u51b3\u5b9a\u6027\u6c34\u5e73\uff1b<\/div>\n
\u2462\u00a0\u5177\u5907\u5747\u5300\u6027\u548c\u7a33\u5b9a\u6027\uff0c\u74f6\u95f4\u53d8\u5f02\u6027\u5e94\u5c0f\u4e8e\u5206\u6790\u7cfb\u7edf\u7684\u53d8\u5f02\uff0c\u5728\u89c4\u5b9a\u7684\u6761\u4ef6\u4e0b\u6709\u826f\u597d\u7684\u7a33\u5b9a\u6027\uff1b<\/div>\n
\u2463\u00a0\u9776\u503c\u6216\u9884\u671f\u7ed3\u679c\u5df2\u77e5\uff1b<\/div>\n
\u2464\u00a0\u65e0\u5df2\u77e5\u7684\u751f\u7269\u4f20\u67d3\u5371\u9669\uff1b<\/div>\n
\u2465\u00a0\u53ef\u5355\u6279\u5927\u91cf\u83b7\u5f97\uff0c\u56e0\u5ba4\u5185\u8d28\u63a7\u662f\u8fde\u7eed\u6d4b\u5b9a\u540c\u4e00\u8d28\u63a7\u54c1\uff0c\u4ee5\u76d1\u6d4b\u5b9e\u9a8c\u5ba4\u6d4b\u5b9a\u7684\u91cd\u590d\u6027\uff08\u53ef\u5927\u91cf\u6301\u7eed\u4f9b\u5e94\uff09\u3002<\/div>\n
\u00a0<\/div>\n
\u4e8c\u3001\u6807\u51c6\u7269\u8d28\uff08\u8d28\u63a7\u54c1\uff09\u7684\u9a8c\u6536\u4e0e\u4fdd\u5b58<\/div>\n
\u53c2\u7167JJF 1507-2015 \u300a\u6807\u51c6\u7269\u8d28\u7684\u9009\u62e9\u4e0e\u5e94\u7528\u6280\u672f\u89c4\u8303\u300b\uff08\u4ee5\u4e0b\u7b80\u79f0\u201cJJF1507-2015\u201d\uff09\u5173\u4e8e\u6807\u51c6\u7269\u8d28\uff08\u8d28\u63a7\u54c1\uff09\u7684\u9a8c\u6536\u4e0e\u4fdd\u5b58\u76f8\u5173\u63cf\u8ff0\uff0c\u6574\u7406\u5982\u4e0b\uff1a<\/div>\n
\u00a0<\/div>\n
1.\u00a0\u5728\u63a5\u6536\u6807\u51c6\u7269\u8d28\u65f6\uff0c\u5e94\u5bf9\u7167\u63d0\u4f9b\u7684\u8bf4\u660e\u786e\u8ba4\u5176\u8fd0\u8f93\u6761\u4ef6\u548c\u63a5\u6536\u72b6\u6001\uff0c\u5e76\u7acb\u5373\u6309\u7167\u8bf4\u660e\u89c4\u5b9a\u7684\u4fdd\u5b58\u6761\u4ef6\u8fdb\u884c\u4fdd\u5b58\uff0c\u5e76\u5728\u4fdd\u8d28\u671f\u5185\u4f7f\u7528\uff08\u53c2\u8003JJF1507-2015 10.1.1\u300110.1.3\uff09\u3002\u5bf9\u4e8e\u6838\u9178\u6807\u51c6\u7269\u8d28\uff0c\u300a\u533b\u7597\u673a\u6784\u4e34\u5e8a\u57fa\u56e0\u6269\u589e\u68c0\u9a8c\u5b9e\u9a8c\u5ba4\u5de5\u4f5c\u5bfc\u5219\u300b\u4e2d\u6307\u51fa\u8bd5\u5242\u76d2\u4e2d\u7684\u9633\u6027\u5bf9\u7167\u54c1\u53ca\u8d28\u63a7\u54c1\u5e94\u5f53\u4fdd\u5b58\u5728\u6807\u672c\u5904\u7406\u533a\u3002<\/div>\n
2.\u00a0\u5bf9\u4e8e\u53ef\u591a\u6b21\u4f7f\u7528\u7684\u6807\u51c6\u7269\u8d28\uff0c\u786e\u4fdd\u5305\u88c5\u5355\u5143\u5f00\u5c01\u540e\u7684\u6070\u5f53\u4fdd\u5b58\u548c\u5305\u88c5\u3001\u6807\u7b7e\u3001\u8bf4\u660e\u89c4\u5b9a\u7684\u5b8c\u6574\u6027\u975e\u5e38\u91cd\u8981\uff0c\u5fc5\u8981\u65f6\u5e94\u5bf9\u5269\u4f59\u7684\u7269\u8d28\u8fdb\u884c\u91cd\u65b0\u5bc6\u5c01\u5305\u88c5\uff08\u53c2\u8003JJF1507-2015 10.1.2\u300110.2.4\uff09\u3002<\/div>\n
3.\u00a0\u5bf9\u4e8e\u4ec5\u4f9b\u4e00\u6b21\u4f7f\u7528\u7684\u6807\u51c6\u7269\u8d28\uff0c\u5728\u6253\u5f00\u5305\u88c5\u540e\u5e94\u6309\u7167\u8981\u6c42\u5c3d\u5feb\u4f7f\u7528\uff0c\u4e0d\u80fd\u7559\u5b58\u540e\u53cd\u590d\u4f7f\u7528\uff08\u53c2\u8003JJF1507-2015 10.1.3\uff09\u3002<\/div>\n
\u00a0<\/div>\n
\u4e09\u3001\u6807\u51c6\u7269\u8d28\uff08\u8d28\u63a7\u54c1\uff09\u7684\u4f7f\u7528<\/div>\n
\u53c2\u7167JJF1507-2015\u5173\u4e8e\u6807\u51c6\u7269\u8d28\u7684\u4f7f\u7528\u65b9\u9762\u76f8\u5173\u63cf\u8ff0\uff0c\u6574\u7406\u5982\u4e0b\uff1a<\/div>\n
1\u3001\u00a0\u4f7f\u7528\u524d\u51c6\u5907\uff1a<\/div>\n
\u5728\u89c4\u5b9a\u7684\u7a0b\u5e8f\u6761\u4ef6\u548c\u6d4b\u91cf\u6761\u4ef6\u8fbe\u5230\u7a33\u5b9a\u540e\u518d\u4f7f\u7528\u6807\u51c6\u7269\u8d28\uff0c\u5426\u5219\u5c06\u9020\u6210\u6807\u51c6\u7269\u8d28\u7684\u8bef\u7528\uff0c\u5e76\u53ef\u80fd\u4ea7\u751f\u9519\u8bef\u7684\u7ed3\u8bba\uff08\u53c2\u8003JJF1507-2015 10.2.1\u300110.2.5\uff09\u3002<\/div>\n
\u00a0<\/div>\n
2\u3001\u00a0\u9884\u5904\u7406\uff1a<\/div>\n
\u5bf9\u4e8e\u9700\u901a\u8fc7\u6df7\u5408\u3001\u7a00\u91ca\u3001\u5206\u88c5\u7b49\u9884\u5904\u7406\u540e\u7684\u6807\u51c6\u7269\u8d28\uff0c\u9700\u8981\u5bf9\u4e0d\u786e\u5b9a\u5ea6\u7684\u6765\u6e90\u8fdb\u884c\u63a7\u5236\uff0c\u5982\u6eb6\u8d28\u6216\u6eb6\u5242\u7684\u6325\u53d1\u6027\u635f\u5931\u3001\u5305\u88c5\u548c\u73af\u5883\uff0c\u8fd8\u6709\u6d4b\u5b9a\u65b9\u6cd5\u3001\u7f13\u51b2\u6db2\u3001\u6700\u7ec8\u7ed3\u679c\u7684\u7edf\u8ba1\u5b66\u8bc4\u4ef7\u548c\u8d28\u91cf\u63a7\u5236\u7b49\u3002\u4e3a\u786e\u4fdd\u7279\u6027\u503c\u7684\u6b63\u786e\u4f20\u9012\uff0c\u907f\u514d\u9884\u5904\u7406\u8fc7\u7a0b\u56e0\u7d20\u7684\u5f71\u54cd\uff0c\u5efa\u8bae\u5bf9\u9884\u5904\u7406\u8fdb\u884c\u9a8c\u8bc1\u8bc4\u4f30\uff0c\u5fc5\u8981\u65f6\u5efa\u7acb\u4e0d\u786e\u5b9a\u5ea6\u8bc4\u4f30\u7a0b\u5e8f\uff0c\u4ee5\u786e\u4fdd\u4e0d\u786e\u5b9a\u5ea6\u7684\u5408\u7406\u91cf\u5316\uff08\u53c2\u8003JJF1507-2015 6.3.3\u300110.2.6\u3001\u300a2021\u4e34\u5e8a\u533b\u5b66\u68c0\u9a8c\u6280\u672f\uff08\u58eb\uff09\u300b\uff09\u3002<\/div>\n
\u00a0<\/div>\n
\u6ce8\uff1aISO\u6307\u535734\u548c35\u5bf9\u6807\u51c6\u7269\u8d28\u7684\u7a33\u5b9a\u6027\u8bc4\u4f30\u8fdb\u884c\u4e86\u8be6\u7ec6\u9610\u8ff0\uff0c\u4e0a\u8ff0\u4e24\u4efd\u6307\u5357\u5df2\u8f6c\u5316\u4e3a\u56fd\u5bb6\u8ba1\u91cf\u6280\u672f\u89c4\u8303JJF1342\u300a\u6807\u51c6\u7269\u8d28\u7814\u5236(\u751f\u4ea7) \u673a\u6784\u901a\u7528\u8981\u6c42\u300b\u548cJJF1343\u300a\u6807\u51c6\u7269\u8d28\u5b9a\u503c\u7684\u901a\u7528\u539f\u5219\u53ca\u7edf\u8ba1\u5b66\u539f\u7406\u300b\u3002\u540c\u65f6\uff0c\u5728\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u65b9\u9762\u53d1\u5e03\u7684YY\/T 1652\u300a\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7528\u8d28\u63a7\u7269\u901a\u7528\u6280\u672f\u8981\u6c42\u300b\u4ea6\u53ef\u4f5c\u4e3a\u53c2\u8003\u6587\u4ef6\u3002<\/div>\n
\u00a0<\/div>\n
3\u3001\u00a0\u53d6\u6837\uff1a<\/div>\n
\u6807\u51c6\u7269\u8d28\u5728\u53d6\u6837\u65f6\u5e94\u786e\u4fdd\u4ee3\u8868\u6027\uff0c\u5982\u679c\u89c4\u5b9a\u4e86\u53d6\u6837\u4e4b\u524d\u5fc5\u8981\u7684\u5747\u5300\u5316\u63aa\u65bd\uff0c\u5982\u6df7\u5300\u7b49\uff0c\u5e94\u4e25\u683c\u6267\u884c\u3002<\/div>\n
\u00a0<\/div>\n
\u5982\u679c\u89c4\u5b9a\u4e86\u6807\u51c6\u7269\u8d28\u7684\u6700\u5c0f\u53d6\u6837\u91cf\uff0c\u90a3\u4e48\u4f7f\u7528\u6807\u51c6\u7269\u8d28\u65f6\u7684\u5b9e\u9645\u53d6\u6837\u91cf\u5e94\u4e0d\u4f4e\u4e8e\u6807\u51c6\u7269\u8d28\u7684\u6700\u5c0f\u53d6\u6837\u91cf\uff0c\u5f53\u5c0f\u4e8e\u6700\u5c0f\u53d6\u6837\u91cf\u65f6\uff0c\u5176\u7279\u6027\u503c\u548c\u4e0d\u786e\u5b9a\u5ea6\u7b49\u53c2\u6570\u53ef\u80fd\u4f1a\u7531\u4e8e\u6807\u51c6\u7269\u8d28\u7684\u4e0d\u5747\u5300\u6027\u800c\u4e0d\u518d\u6709\u6548\uff08\u53c2\u8003JJF1507-2015 10.2.2\uff09\u3002\u53d6\u6837\u65f6\u5e94\u91c7\u53d6\u9632\u6b62\u6c61\u67d3\u7684\u63aa\u65bd\uff08\u53c2\u8003JJF1507-2015 10.2.4\uff09\u3002<\/div>\n
\u00a0<\/div>\n
\u5bf9\u4e8e\u6838\u9178\u6807\u51c6\u7269\u8d28\u7684\u4f7f\u7528\uff0c\u8fd8\u9700\u6ce8\u610f\uff1a<\/div>\n
\uff081\uff09\u5bf9\u4e8e\u6db2\u4f53\u72b6\u6001\uff0c\u5728\u5f00\u76d6\u524d\u79bb\u5fc3\u4ee5\u9632\u4ea7\u54c1\u635f\u8017\uff0c\u5e76\u6309\u7167\u8bf4\u660e\u4e2d\u7684\u7a00\u91ca\u3001\u5206\u88c5\u5efa\u8bae\u8fdb\u884c\u64cd\u4f5c\uff1b<\/div>\n
\uff082\uff09\u5bf9\u4e8e\u77f3\u8721\u5207\u7247\uff08\u5982FFPE\uff09\uff0c\u5e94\u5bf9\u6838\u9178\u63d0\u53d6\u6b65\u9aa4\uff0c\u5e94\u5efa\u7acb\u6280\u672f\u6807\u51c6\u3001\u64cd\u4f5c\u4e0e\u8d28\u63a7\u89c4\u7a0b\u5e76\u4fdd\u5b58\u8fc7\u7a0b\u8bb0\u5f55\uff1b<\/div>\n
\uff083\uff09\u51bb\u5e72\u72b6\u6001\u7684\u6838\u9178\u6807\u51c6\u7269\u8d28\u7684\u5728\u8fdb\u884c\u590d\u6eb6\u65f6\uff0c\u6240\u52a0\u6eb6\u5242\u7684\u91cf\u8981\u51c6\u786e\uff0c\u6bcf\u6b21\u52a0\u5165\u7684\u91cf\u5c3d\u91cf\u4e00\u81f4\uff0c\u5e94\u8f7b\u8f7b\u6447\u5300\uff0c\u4f7f\u5185\u5bb9\u7269\u5b8c\u5168\u6eb6\u89e3\uff0c\u5207\u5fcc\u5267\u70c8\u632f\u6447\u3002<\/div>\n
\u00a0<\/div>\n
4\u3001\u4f7f\u7528<\/div>\n
\u5bf9\u4e8e\u5b9a\u6027\u68c0\u6d4b\uff0c\u901a\u5e38\u6709\u5f31\u9633\u6027\u8d28\u63a7\u54c1\u548c\u9634\u6027\u8d28\u63a7\u54c1\u53ef\u4ee5\u6ee1\u8db3\u8981\u6c42\u3002<\/div>\n
\u5bf9\u4e8e\u5b9a\u91cf\u68c0\u6d4b\uff0c\u5219\u8981\u6839\u636e\u5b9e\u9a8c\u7684\u6d4b\u5b9a\u8303\u56f4\u3002\u4f7f\u7528\u9633\u6027\u8d28\u63a7\u54c1\u4e0d\u4f46\u53ef\u68c0\u6d4b\u6269\u589e\u53cd\u5e94\u6db2\u7684\u8d28\u91cf\uff0c\u8fd8\u53ef\u83b7\u5f97\u68c0\u6d4b\u8bd5\u5242\u7684\u68c0\u6d4b\u7684\u4e0b\u9650\u4fe1\u606f\u3002\u4f7f\u7528\u9634\u6027\u8d28\u63a7\u54c1\u4e3b\u8981\u76ee\u7684\u662f\u76d1\u6d4b\u6c61\u67d3\uff0c\u5305\u62ec\u5b9e\u9a8c\u5ba4\u4ee5\u524d\u7684\u6269\u589e\u4ea7\u7269\u7684\u6c61\u67d3\u3001\u6709\u5b9e\u9a8c\u64cd\u4f5c\u6240\u81f4\u7684\u6807\u672c\u4e4b\u95f4\u7684\u4ea4\u53c9\u6c61\u67d3\u3001\u6269\u589e\u53cd\u5e94\u8bd5\u5242\u7684\u6c61\u67d3\u7b49\u3002<\/div>\n
\u00a0<\/div>\n
\u56db\u3001\u90e8\u5206\u6587\u4ef6\u63d0\u5230\u7684\u7b2c\u4e09\u65b9\u8d28\u63a7\u54c1\u76f8\u5173\u5efa\u8bae<\/div>\n
\u00a0<\/div>\n
\u7b2c\u4e09\u65b9\u8d28\u63a7\u54c1\u4e0d\u4ec5\u53ef\u4f7f\u7528\u5728\u5b9e\u9a8c\u5ba4\u7684\u65b9\u65b9\u9762\u9762\uff0c\u800c\u4e14\u5728\u4e34\u5e8a\u68c0\u9a8c\u4e2d\u4e5f\u8d77\u5230\u4e0d\u53ef\u5ffd\u89c6\u7684\u4f5c\u7528\uff1a<\/div>\n
\u00a0<\/div>\n
1. ISO 15189\uff1a2012\uff08\u300aMedical laboratories \u2014 Requirements for quality and competence\u300b\uff09\u63d0\u5230\u201cUse of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer\u201d\uff0c\u5176\u5efa\u8bae\u5b9e\u9a8c\u5ba4\u4f7f\u7528\u300e\u72ec\u7acb\u300f\u7b2c\u4e09\u65b9\u8d28\u63a7\u54c1\u3002<\/div>\n
\u00a0<\/div>\n
2. \u6839\u636e\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u6807\u51c6\u5316\u534f\u4f1aCLSI\u53d1\u5e03\u7684CLSI C24-Ed3\uff08\u300aClinical and Laboratory Standards Institute guideline C24\u2014Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions\u300b\u7684\u7b2c\u4e09\u7248\uff0c\u4e2d\u6240\u63d0\u201cControl materials made by a third party that has no relationship to the measurement procedure manufacturer or to the calibrator, sometimes referred to as third party controls, are developed independently without any influence from the instrument or reagent manufacturer\u201d\uff0c\u5f3a\u8c03\u7b2c\u4e09\u65b9\u8d28\u63a7\u54c1\u4e0d\u53d7\u4efb\u4f55\u4eea\u5668\u6216\u8005\u8bd5\u5242\u5382\u5546\u7684\u5f71\u54cd\u3002<\/div>\n
\u00a0<\/div>\n
3. \u536b\u751f\u90e8\u4e34\u5e8a\u68c0\u9a8c\u4e2d\u5fc3\u53d1\u5e03\u7684GB\/T 20468-2006\u300a\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u5b9a\u91cf\u6d4b\u5b9a\u5ba4\u5185\u8d28\u91cf\u63a7\u5236\u6307\u5357\u300b\u4e2d\u63d0\u5230\uff0c\u6bcf\u4e00\u4e2a\u5206\u6790\u6279\u957f\u5ea6\u5185\u81f3\u5c11\u5bf9\u8d28\u63a7\u54c1\u505a\u4e00\u6b21\u68c0\u6d4b\u3001\u5206\u6790\u7cfb\u7edf\u6216\u8bd5\u5242\u7684\u5382\u5546\u5e94\u63a8\u8350\u6bcf\u4e2a\u5206\u6790\u6279\u4f7f\u7528\u8d28\u63a7\u54c1\u6570\u91cf\u53ca\u653e\u7f6e\u4f4d\u7f6e\u3002\u5728PCR\u68c0\u6d4b\u4e2d\uff0c\u4ece\u6838\u9178\u63d0\u53d6\u5230\u6269\u589e\u5373\u4e3a\u4e00\u4e2a\u5206\u6790\u6279\u3002<\/div>\n
\u00a0<\/div>\n
4. \u5728\u8054\u9632\u8054\u63a7\u673a\u5236\u533b\u7597\u53d1\u5e03\u7684\u300a\u533b\u7597\u673a\u6784\u65b0\u578b\u51a0\u72b6\u75c5\u6bd2\u6838\u9178\u68c0\u6d4b\u5de5\u4f5c\u624b\u518c\uff08\u8bd5\u884c\u00a0\u7b2c\u4e8c\u7248\uff09\u300b\u4e2d\uff0c\u5173\u4e8e\u5b9e\u9a8c\u5ba4\u8d28\u91cf\u63a7\u5236\u4e0e\u7ba1\u7406\u7684\u90e8\u5206\u63d0\u5230\uff1a\u201c\u5ba4\u5185\u8d28\u63a7\u6bcf\u6279\u68c0\u6d4b\u81f3\u5c11\u67091\u4efd\u5f31\u9633\u6027\u8d28\u63a7\u54c1\uff08\u7b2c\u4e09\u65b9\u8d28\u63a7\u54c1\uff0c\u901a\u5e38\u4e3a\u68c0\u51fa\u9650\u76841.5-3\u500d\uff09\u30013\u4efd\u9634\u6027\u8d28\u63a7\u54c1\uff08\u751f\u7406\u76d0\u6c34\uff09\u3002\u8d28\u63a7\u54c1\u968f\u673a\u653e\u5728\u4e34\u5e8a\u6807\u672c\u4e2d\uff0c\u53c2\u4e0e\u4ece\u63d0\u53d6\u5230\u6269\u589e\u7684\u5168\u8fc7\u7a0b\u2026\u2026\u201d<\/div>\n
\u83c1\u826f\u76ee\u5f55\u4ea7\u54c1<\/div>\n
\u56fa\u5b9a\u7684\u7a81\u53d8\u4f4d\u70b9\u7ec4\u5408\u548c\u7a81\u53d8\u9891\u7387\uff0c\u591a\u79cd\u4ea7\u54c1\u5f62\u5f0f\uff08gDNA\/FFPE\/ctDNA\uff09<\/div>\n
\u00a0<\/div>\n
\u25a0\u00a0\u6cdb\u80bf\u7624800gDNA\u6807\u51c6\u54c1<\/div>\n
\u662f\u4e00\u6b3e\u9488\u5bf9\u5927panel\u8bbe\u5b9a\u7684gDNA\u6807\u51c6\u54c1\uff0c\u5176\u5305\u542b\u8fd1800\u4e2a\u6cdb\u80bf\u7624\u57fa\u56e0\u53d8\u5f02\u4f4d\u70b9\uff0c\u5206\u522b\u7ecf\u8fc7\u6570\u5b57PCR\u548cWES\u9a8c\u8bc1\uff0c\u7a81\u53d8\u4f4d\u70b9\u9891\u7387\u4ece1%\u5230100%\u3002\u8be5\u4ea7\u54c1\u6709\u52a9\u4e8e\u4fee\u6b63\u548c\u76d1\u6d4bNGS\u5b9e\u9a8c\u65b9\u6848\u3001\u64cd\u4f5c\u89c4\u8303\u53ca\u751f\u7269\u4fe1\u606f\u5b66\u6d41\u7a0b\u7b49\uff0c\u5e76\u8fdb\u884c\u540e\u7eed\u7684\u4e00\u7cfb\u5217\u5e94\u7528\u3002<\/div>\n
\u00a0<\/div>\n
\u25a0\u00a0FFPE\u6807\u51c6\u54c1<\/div>\n
\u5305\u542b\u591a\u4e2a\u70ed\u95e8\u7684\u764c\u79cd\u76f8\u5173\u57fa\u56e0\u7a81\u53d8\u4f4d\u70b9\uff0c\u5982EGFR\u3001KRAS\u3001ALK\u3001MET\u7b49\u57fa\u56e0\u3002\u5305\u542b\u591a\u79cd\u53d8\u5f02\u7c7b\u578b\uff0c\u5982\uff1aSNV\u3001\u63d2\u5165\/\u7f3a\u5931\u3001\u62f7\u8d1d\u6570\u53d8\u5f02\/\u6269\u589e\u3001\u57fa\u56e0\u878d\u5408\u7b49\u3002<\/div>\n
\u00a0<\/div>\n
\u25a0\u00a0\u80ba\u764cctDNA\u6807\u51c6\u54c1\u5957\u88c5<\/div>\n
\u6db5\u76d6\u591a\u4e2a\u57fa\u56e0\u53d8\u5f02\uff0c\u5305\u542b\u4e86\u7ecf\u8fc7 ddPCR \u9a8c\u8bc1\u76846\u4e2aSNV\u30011\u4e2a\u63d2\u5165\u53ca1\u4e2a\u7f3a\u5931\u53d8\u5f02\u4f4d\u70b9\uff0c\u4e14\u6bcf\u4e2a\u4f4d\u70b9\u5747\u542b\u67090%\u30010.1%\u30011%\u4e09\u4e2a\u68af\u5ea6\u7684\u7a81\u53d8\u9891\u7387\uff0c\u53ef\u7528\u4e8e\u6700\u4f4e\u68c0\u6d4b\u9650\u7684\u9a8c\u8bc1\u53ca\u7ebf\u6027\u9a8c\u8bc1\u3002<\/div>\n
\u00a0<\/div>\n
\u25a0\u00a0COVID-19 \u5047\u75c5\u6bd2\u5168\u57fa\u56e0\u7ec4\u8d28\u63a7\u54c1<\/div>\n
\u9ad8\u5ea6\u6a21\u62df\u771f\u5b9e\u4e34\u5e8a\u6837\u672c\uff0c\u8986\u76d6\u75c5\u6bd2\u5168\u57fa\u56e0\u7ec4\u5e8f\u5217\uff0c\u9002\u914d\u5e02\u573a\u4e0a\u83b7\u6279\u7684\u6838\u9178\u68c0\u6d4b\u8bd5\u5242\u76d2\uff1b\u5047\u75c5\u6bd2\u4ea7\u54c1\u5f62\u5f0f\uff0c\u80fd\u4ece\u63d0\u53d6\u6b65\u9aa4\u5f00\u59cb\u8d28\u63a7\u68c0\u6d4b\u5168\u6d41\u7a0b\uff1b\u66f4\u7a33\u5b9a\uff0c\u53ef\u5e38\u6e29\u8fd0\u8f93\u3002<\/div>\n
\u00a0<\/div>\n
\u83c1\u826f\u5b9a\u5236\u4ea7\u54c1\u53ca\u670d\u52a1<\/div>\n
\u53ef\u6839\u636e\u7528\u6237\u9700\u6c42\u8fdb\u884c\u80bf\u7624CDx\u3001TMB\u3001MSI\u3001HRR\/HRD\u3001NIPT\u7b49\u591a\u9879\u4e2a\u6027\u5316\u4ea7\u54c1\u5b9a\u5236\u3002<\/div>\n
\u25a0\u00a0TMB\u6807\u51c6\u54c1<\/div>\n
\u80bf\u7624\u6765\u6e90\u7ec6\u80de\u7cfb\u53ca\u6b63\u5e38\u7ec4\u7ec7\u6765\u6e90\u7ec6\u80de\u7cfb\u7684\u914d\u5bf9\u6837\u672c\uff0cTMB\u503c\u5305\u542b\u4ece3\u523026\u591a\u4e2a\u68af\u5ea6\uff0c\u6709gDNA\u3001ctDNA\u3001FFPE\u591a\u79cd\u4ea7\u54c1\u5f62\u5f0f\uff0c\u63d0\u4f9b\u914d\u5957\u5b8c\u6574WES\u6570\u636e\u3001TMB\u5206\u6790\u6d41\u7a0b\u53caTMB\u53c2\u8003\u503c\u3002<\/div>\n
\u00a0<\/div>\n
\u25a0\u00a0HRR\u8d28\u63a7\u54c1<\/div>\n
\u5305\u542b\u4e0eHRR\u901a\u8def\u76f8\u5173\u7684\u57fa\u56e0\u7a81\u53d8\uff0c\u53ef\u5b9a\u5236Pathogenic\uff0clikely Pathogenic, VUS, likely benign, benign\u591a\u79cd\u4e34\u5e8a\u610f\u4e49\u7684\u7a81\u53d8\u4f4d\u70b9\uff0c\u662fHRR\u68c0\u6d4b\u8bd5\u5242\u76d2\u6ce8\u518c\u62a5\u8bc1\u53caHRR\u68c0\u6d4b\u65e5\u5e38\u8d28\u63a7\u7406\u60f3\u7684\u53c2\u8003\u54c1\u3002<\/div>\n
\u00a0<\/div>\n
\u25a0\u00a0HRD\u6807\u51c6\u54c1<\/div>\n
\u5982\u679cCDx Panel\u4e2dHRD\u72b6\u6001\u662f\u901a\u8fc7\u68c0\u6d4b\u57fa\u56e0\u7ec4\u7622\u75d5\uff0c\u4e5f\u53ef\u9009\u62e9\u83c1\u826f\u63d0\u4f9b\u7684\u901a\u8fc7HRD \u57fa\u56e0\u7ec4\u7622\u75d5\u7684\u68c0\u6d4b\u65b9\u6cd5\u6765\u8bc4\u4f30HRD\u72b6\u6001\u7684\u6807\u51c6\u54c1\u3002\u4f8b\u5982\u901a\u8fc7LOH\uff0cLST\uff0cTAI\u7684\u7efc\u5408\u8bc4\u5206\uff0c\u6765\u8ba1\u7b97HRD \u5206\u503c\u3002\u540c\u65f6\uff0c\u83c1\u826f\u4e5f\u53ef\u63d0\u4f9bHRD panel\u6027\u80fd\u9a8c\u8bc1\u7684\u5404\u79cd\u53c2\u8003\u54c1\uff0c\u4f8b\u5982\u7279\u5f02\u6027\uff0c\u7075\u654f\u6027\uff0c\u7cbe\u5bc6\u5ea6\uff0c\u6297\u5e72\u6270\u80fd\u529b\u9a8c\u8bc1\u53c2\u8003\u54c1\u3002<\/div>\n
\u00a0<\/div>\n
\u53c2\u8003\u8d44\u6599\uff1a<\/div>\n
1\u3001\u300a\u4e09\u7ea7\u7efc\u5408\u533b\u9662\u8bc4\u5ba1\u6807\u51c6\uff082011\u5e74\u7248\uff09\u300b\uff08\u536b\u533b\u7ba1\u53d1\u30142011\u301533\u53f7\uff09<\/div>\n
2\u3001\u300a\u533b\u7597\u673a\u6784\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u536b\u533b\u53d1[2006]73\u53f7\uff09<\/div>\n
3\u3001\u300a\u533b\u7597\u673a\u6784\u4e34\u5e8a\u57fa\u56e0\u6269\u589e\u68c0\u9a8c\u5b9e\u9a8c\u5ba4\u7ba1\u7406\u529e\u6cd5\u300b\uff08\u536b\u529e\u533b\u653f\u53d1[2010]194\u53f7\uff09\u53ca\u9644\u4ef6\u533b\u7597\u673a\u6784\u4e34\u5e8a\u57fa\u56e0\u6269\u589e\u68c0\u9a8c\u5b9e\u9a8c\u5ba4\u5de5\u4f5c\u5bfc\u5219<\/div>\n
4\u3001\u300a2021\u4e34\u5e8a\u533b\u5b66\u68c0\u9a8c\u6280\u672f\uff08\u58eb\uff09\u300b\uff08\u4eba\u6c11\u536b\u751f\u51fa\u7248\u793e\u00a02020\u5e7411\u6708\u7b2c1\u7248\uff09<\/div>\n
5\u3001GB\/T 20468-2006\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u5b9a\u91cf\u6d4b\u5b9a\u5ba4\u5185\u8d28\u91cf\u63a7\u5236\u6307\u5357\uff08\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u56fd\u5bb6\u8d28\u91cf\u76d1\u7763\u68c0\u9a8c\u68c0\u75ab\u603b\u5c40\u3001\u4e2d\u56fd\u56fd\u5bb6\u6807\u51c6\u5316\u7ba1\u7406\u59d4\u5458\u4f1a\u53d1\u5e03\u4e8e2006-09-01\uff0c\u8d77\u8349\u5355\u4f4d\uff1a\u536b\u751f\u90e8\u4e34\u5e8a\u68c0\u9a8c\u4e2d\uff09<\/div>\n
6\u3001JJF 1507-2015 \u300a\u6807\u51c6\u7269\u8d28\u7684\u9009\u62e9\u4e0e\u5e94\u7528\u6280\u672f\u89c4\u8303\u300b\uff08\u56fd\u5bb6\u8d28\u91cf\u76d1\u7763\u68c0\u9a8c\u68c0\u75ab\u603b\u5c40\u53d1\u5e03\u4e8e2015-01-30\uff0c\u4e3b\u8981\u53c2\u7167ISO\u6307\u535733\uff09<\/div>\n
7\u3001\u68c0\u9a8c\u533b\u5b66\u5b9e\u9a8c\u5ba4\u8d28\u91cf\u7ba1\u7406\u6307\u5357\uff08\u4e0a\u6d77\u79d1\u5b66\u6280\u672f\u6587\u732e\u51fa\u7248\u793e2014\u5e743\u6708\u7b2c1\u6b21\u5370\u5237\uff09<\/div>\n
8\u3001YY\/T 1652-2019\u300a\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u7528\u8d28\u63a7\u7269\u901a\u7528\u6280\u672f\u8981\u6c42\u300b\uff08\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u53d1\u5e03\u4e8e2019-05-31\uff09<\/div>\n
9\u3001ISO 15189\uff1a2012 Medical laboratories \u2014 Requirements for quality and competence<\/div>\n
10\u3001CLSI C24-Ed3\u00a0Clinical and Laboratory Standards Institute guideline C24\u2014Statistical Quality 8\u3001Control for Quantitative Measurement Procedures: Principles and Definitions<\/div>\n
11\u3001\u5173\u4e8e\u5370\u53d1\u533b\u7597\u673a\u6784\u65b0\u578b\u51a0\u72b6\u75c5\u6bd2\u6838\u9178\u68c0\u6d4b\u5de5\u4f5c\u624b\u518c\uff08\u8bd5\u884c\u00a0\u7b2c\u4e8c\u7248\uff09\u7684\u901a\u77e5\uff08\u8054\u9632\u8054\u63a7\u673a\u5236\u533b\u7597\u53d1\u30142020\u3015313\u53f7\uff09<\/div>\n
\u00a0<\/div>\n
\u63a8\u8350\u9605\u8bfb<\/div>\n
\u73af\u7403\u7f51\uff1a\u4eba\u7c7b\u57fa\u56e0\u7ec4\u8ba1\u5212\u5e26\u7ed9\u6211\u4eec\u7684\u91cd\u8981\u542f\u793a<\/a><\/div>\n
\u4e13\u8bbf\u83c1\u826f\u57fa\u56e0\u521b\u59cb\u4eba\u674e\u83c1\u534e\u535a\u58eb<\/a>\u5b8f\u57fa\u56e0\u7ec4\u6d4b\u5e8f\u7a81\u7834\u4f20\u7edf\u8bca\u65ad\u65b9\u6cd5\u5c40\u9650\u6027<\/a><\/p>\n
\u00a0<\/div>\n
\u3010\u58f0\u660e\u3011\u4e3a\u4f20\u64ad\u79d1\u5b66\u4fe1\u606f\uff0c\u63a8\u52a8\u57fa\u56e0\u53ca\u6570\u5b57\u751f\u547d\u5065\u5eb7\u4ea7\u5b66\u7814\u8fde\u63a5\uff0c\u6211\u4eec\u79c9\u6301\u4e2d\u7acb\u3001\u4e13\u4e1a\u3001\u8d4b\u80fd\u7684\u7406\u5ff5\u6536\u96c6\u3001\u5206\u6790\u6216\u53d1\u5e03\u4fe1\u606f\u3002\u4f46\u7531\u4e8e\u65f6\u6548\u6027\u53ca\u884c\u4e1a\u7279\u6b8a\u6027\uff0c\u6240\u520a\u767b\u5185\u5bb9\u4ec5\u4f9b\u7814\u7a76\u53c2\u8003\uff0c\u4e0d\u4f5c\u4e3a\u51b3\u7b56\u4f9d\u636e\uff1b\u672c\u6587\u76f8\u5173\u4fe1\u606f\u4e0d\u4ee3\u8868\u57fa\u56e0\u6167\u673a\u6784\u7684\u89c2\u70b9\uff1b\u201c\u57fa\u56e0\u6167\u201d\u520a\u767b\u7684\u539f\u521b\u5185\u5bb9\u7684\u77e5\u8bc6\u4ea7\u6743\u4e3a\u201c\u57fa\u56e0\u6167\u201d\u5546\u6807\u62e5\u6709\u8005\u53ca\u76f8\u5173\u6743\u5229\u4eba\u6240\u6709\uff1b\u6b22\u8fce\u8f6c\u8f7d\uff0c\u8f6c\u8f7d\u8bf7\u7533\u8bf7\u5e76\u6ce8\u660e\u6765\u6e90\u3002\u6b22\u8fce\u4e2a\u4eba\u53ca\u673a\u6784\u6295\u7a3f\u53ca\u5408\u4f5c\u3002<\/div>\n
\u00a0<\/div>\n
\u00a0\u5173\u4e8e\u83c1\u826f\u57fa\u56e0\u00a0<\/div>\n
\u83c1\u826f\u4f5c\u4e3a\u56fd\u5185\u5206\u5b50\u8bca\u65ad\u6807\u51c6\u54c1\u7814\u53d1\u751f\u4ea7\u5546\u9886\u8dd1\u8005\uff0c\u62e5\u6709\u5168\u7403\u63a5\u53d7\u53ca\u4f7f\u7528\u8303\u56f4\u6700\u5927\u7684\u6807\u51c6\u54c1\u7814\u53d1\u751f\u4ea7\u5e73\u53f0\uff0c\u7d2f\u79ef\u8fd1\u5343\u7ec6\u80de\u7cfb\u8d44\u6e90\uff0c\u80fd\u591f\u6301\u7eed\u7a33\u5b9a\u5730\u4e3a\u7528\u6237\u63d0\u4f9b\u9884\u671f\u548c\u6ee1\u610f\u7684\u5408\u683c\u4ea7\u54c1\u3002<\/div>\n<\/div>\n\n
\n![\"RmFicvQBAkgAeFMK0ia5Cab3334OUN1mUBG4bibxEzJJC01MPtSxIgRZcJvf6IGrU6cWAaTKdqM8GkEbzxEfFiaWCQ\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgAeFMK0ia5Cab3334OUN1mUBG4bibxEzJJC01MPtSxIgRZcJvf6IGrU6cWAaTKdqM8GkEbzxEfFiaWCQ.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n<\/div>","protected":false},"excerpt":{"rendered":"
\u4e3b\u8981\u53c2\u8003\u300a2021\u4e34\u5e8a\u533b\u5b66\u68c0\u9a8c\u6280\u672f\uff08\u58eb\uff09\u300b\u53ca\u300a\u6807\u51c6\u7269\u8d28\u7684\u9009\u62e9\u4e0e\u5e94\u7528\u6280\u672f\u89c4\u8303\u300b<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[996],"tags":[1674],"class_list":["post-8938","post","type-post","status-publish","format-standard","hentry","category-news","tag-1674"],"_links":{"self":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts\/8938","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/comments?post=8938"}],"version-history":[{"count":3,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts\/8938\/revisions"}],"predecessor-version":[{"id":13629,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts\/8938\/revisions\/13629"}],"wp:attachment":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/media?parent=8938"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/categories?post=8938"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/tags?post=8938"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}