×òÌ죨6ÔÂ2ÈÕ£©£¬Á½½Í¶×ʼ¯ÍŵÚÁùÆÚ¡°Ã÷Ôºþ¸É²¿´ó½²Ì³¡±ÔÚÖØÇì¾ÙÐС£ÍþÁ®Ï£¶ûwilliamhillÒ½Ò©¶Ê³¤ÍõÍ¢´º£¬ÍþÁ®Ï£¶ûwilliamhillÒ½Ò©Ê×ϯ¿ÆÑ§¼Ò£¨Ò½ÁÆÆ÷еƫÏò£©¡¢×Ó¹«Ë¾¾Å̩ҩе×ܾÀíÀîÇ¿ÊÜÑû³öϯ´Ë´Î¼¯»á²¢¾ÍÉúÎïÒ½Ò©¹¤ÒµÏà¹Ø»°Ìâ×÷רÌⱨ¸æ¡£Á½½Í¶×ʼ¯ÍÅÏà¹ØÖ÷ÒªÁìµ¼¡¢×Ó¹«Ë¾°à×Ó³ÉÔ±¡¢Ö÷ÒªÖвã¸É²¿¼°²¿·ÖÖ°¹¤½ü200È˼ÓÈëÁË´Ë´ÎÔ˶¯¡£±¨¸æÖУ¬ÍõÍ¢´ºÖØÐÂÒ©Ñз¢Á÷³Ì¡¢¹ú¼ÒÒ©Îï¼à¹ÜÌåϵÉú³¤¡¢ÉúÎïÒ½Ò©¹¤ÒµµÄÉú³¤»úÔµ¡¢ÇøÓòÉúÎïÒ½Ò©¹¤ÒµÉú³¤½¨ÉèµÈ4¸ö·½Ãæ³ö·¢£¬¶ÔÉúÎïÒ½Ò©¹¤ÒµµÄÕûÌåÐÎÊÆ½øÐÐÁËÏêϸ½²½â¡£ÀîÇ¿Ôò´ÓÒ½ÁÆÆ÷еÐÐÒµÉú³¤Çé¿ö¡¢Ñз¢ºÍÉÏÊз¾¶¡¢Î´À´¹¤ÒµÉú³¤Ç÷ÊÆµÈ·½Ã棬ϵͳ½²½âÁËÒ½ÁÆÆ÷еÐÐÒµÉú³¤ÃæÁÙµÄлúÔµ¡£ÎªÁËÔöǿѧϰЧ¹û£¬½²Ì³»¹ÔöÉèÁË»¥¶¯ÌáÎÊ»·½Ú¡£ÔÚ×ù¸É²¿Ö°¹¤»®·Ö¾ÍÒ½Ò©CDMOÐÐҵδÀ´Éú³¤Ç÷ÊÆ¡¢¿¹Ì忹ÔÐÐÒµÊг¡Ç°¾°¡¢ÖÊ×ÓÖÎÁƵÄÁÙ´²Ó¦ÓõÈÎÊÌâÓ»Ô¾ÌáÎÊ¡£Á½Î»Ö÷½²È˶¼Ò»Ò»¸øÓèÁËϸÖÂÏ꾡µÄ½â´ð¡£½²×ùºó£¬Á½½Í¶×ʼ¯ÍŸɲ¿Ö°¹¤·×·×ÌåÏÖ£¬´Ë´Î½²×ùÄÚÈݸ»ºñ¡¢¼û½â¶Àµ½¡¢ÊÓ½ÇÆæÌØ£¬¼ÈÓÐרҵ¸ß¶È¡¢Ë¼ÏëÉî¶È£¬ÓÖÓÐʵ¼ùºñ¶È¡£
2021-06-03±¾ÆÚ¡¶Ô¬À´Èç´Ë¡·ÎªÏµÁÐÎÄÕ¡¶´ó·Ö×ÓÉúÎïÆÊÎö¸ÅÂÛ¡·µÄµÚ°Ëƪ£¬Ö¼ÔÚÆ¾¾ÝÒÑÐû²¼µÄÎÄÏ××ÊÁÏ£¬¿ª¶Ë½éÉÜLBAÖеÄÖÊÁ¿¿ØÖÆÑùÆ·£¨QC£¬quality control£©ÖƱ¸¡¢ÈÏÖ¤£¨qualification£©ºÍÅú´ÎÒ»ÖÂÐÔά»¤µÄÏà¹Ø¿´·¨ºÍʵ¼ù¡£ÓÉÓÚÄÚÈÝÆª·ù½Ï³¤£¬±¾ÎĽ«½ÓÄÉÉÏÏÂÆªÐÎʽ½øÐÐÍÆËÍ£¬¾´Çë´¹×¢£¡¡¶Ô¬À´Èç´Ë¡·×¨À¸Ïµ¹ãÖÝÍþÁ®Ï£¶ûwilliamhillҽҩ΢ÐÅÃñÖںŴòÔìµÄ¿ÆÆÕѧÊõרÀ¸£¬ÄÚÈݾùΪÍþÁ®Ï£¶ûwilliamhillÒ½Ò©×Ó¹«Ë¾ÉîÛÚ²©Èð¸±×ܾÀíÔ¬ÖDz©Ê¿Ô´´¡£1.µ¼ÂÛÅäÌå½áºÏ²âÊÔÒªÁ죨LBA£©µÄÐÔÄÜ£¬ÔÚÑо¿Ç°ÒªÁìÑéÖ¤ºÍÑо¿ÖÐÑùÌìÖ°ÎöÆÚ¼ä£¬ÌåÏÖÔÚQCµÄЧÄÜ¡£ÐèÒª½ÓÄÉÑϸñºÍ¼È¶¨µÄÒªÁìºÏÀíµØÖÎÀíQCÑùÆ·µÄÉúÃüÖÜÆÚ£¬ÄÚÈݰüÀ¨ÖƱ¸¡¢ÖÊÁ¿¿ØÖÆÒÔ¼°QCÐÔÄÜµÄ¼à¿Ø¡£ËäÈ»ÔÚ¼à¹Ü»ú¹¹µÄÖ¸ÄϺÍÓйØLBAµÄÎÄÏ×ÖÐÓйØÓÚQCÑùÆ·µÄÖÆ±¸ºÍÈÏÖ¤½ÓÊܱê×¼£¨acceptance criteria£©µÄÏà¹ØÌÖÂÛ£¬µ«´ËÀàÎÄÏ×Ö»ÊǽÏΪ¿ª¶ËµØÌÖÂÛÁËÕâЩ²ÎÊý£¬ÇÒֻɿ¼°ÒªÁ쿪·¢ºÍÑо¿Ç°ÑéÖ¤µÄ½×¶Î£¬²¢Ã»ÓжÔQCÉúÃüÖÜÆÚÖÎÀíµÄÎÊÌâºÍ¶ÔÕâÒ»Àú³ÌÖÁ¹ØÖØÒªµÄÒòËØ×ö³öÌÖÂÛÏ¢Õù´ð¡£¹ØÓÚÐÂQCÅú´ÎµÄÉú²úºÍÈÏÖ¤£¨ÓÃÀ´¼á³ÖQCÅú´Î¼äµÄÒ»ÖÂÐԺͱÜÃâ²âÊÔ½á¹ûÆ«ÒÆ£©µÄÐí¶àÎÊÌâÈÔȻûÓлñµÃ½â¾ö¡£±ðµÄ£¬´ó´ó¶¼ÉúÎïÆÊÎöʵÑéÊÒȱ·¦½¡È«µÄÒªÁì»òͳ¼Æ¹¤¾ßÀ´¼à²âQCÇ÷ÊÆ£¬¶øÕâÖÖ¼à²â¹ØÓÚQCÐÔÄÜÒÔ¼°ÉúÃüÖÜÆÚµÄÖÎÀíÊÇÖÁ¹ØÖØÒªµÄ¡£±¾ÎÄÖ¼ÔÚÌî²¹ÕâÒ»·½ÃæµÄ¿Õ°×£¬ÎªQCÑùÆ·ÉúÃüÖÜÆÚµÄÖÎÀí¼°Æä×é³É²¿·ÖÌṩָµ¼¡¢½¨ÒéºÍ×î¼Ñʵ¼ù¡£ÕâÆäÖаüÀ¨£ºQCµÄÖÆ±¸¡¢ÈÏÖ¤ºÍÆäÐÔÄÜÇ÷ÊÆµÄ¼à¿Ø¡£×ÊÖúÉúÎïÆÊÎöʵÑéÊÒ£¬ÔÚÆä±ê×¼²Ù×÷³ÌÐò £¨SOPs£©ÖУ¬½ç˵QCµÄÈÏÖ¤£¬²¢Öƶ¨Åú´Î¼äÒ»ÖÂÐÔµÄÖ¸µ¼ÔÔò¡£Ó¦µ±ÔÚÒÑÑéÖ¤µÄÆÊÎöÒªÁì»òÿ¸öʵÑéÊÒµÄÑùÌìÖ°Îö¼Æ»®ÖУ¬¶ÔÑо¿ºÍÆÊÎöÒªÁìÌØÒìÐԵľßÌåÒªÇó£¨assay- and study-specific requirements£©ºÍ¹æ·¶¼ÓÒÔ¿¼ÂǺÍ×ö³öÏêϸ˵Ã÷¡£±¾ÎÄÖ÷ÒªÆ«ÖØÓÚÓÃÓÚLBA¶¨Á¿ºÍ¶¨ÐÔÆÊÎöÖеÄQC£¬ÈçÒ©´ú¶¯Á¦Ñ§£¨PK£©ºÍ¿¹Ò©ÎÌ壨ADA£©µÄ²âÊÔ¡£ÆäËûÀà±ðµÄ²âÊÔÒªÁì²»ÔÚÌÖÂÛµÄÁìÓò¡£2.ÖÊÁ¿¿ØÖÆÑùÆ·µÄÖÆ±¸±ê׼Ʒ£¨Reference standard£©¡¢»ìÏýÑù±¾»ùÖÊ¡¢QCµÄ×é³ÉÉí·Ö¡¢É豸ºÍÉú²úÕ½ÂÔ¶¼ÊÇÖÆ±¸ÓÃÓÚLBAµÄQCÑùÆ·µÄÒªº¦ÒòËØ¡£ÒÔϸ÷½Ú½«Æ¾¾ÝÕâЩÒòËØÕ¹¿ªÌÖÂÛ¡£ÖÊÁ¿¿ØÖÆÑùÆ·£¨Quality Controls£©µÄ×é³É£¨composition£©QCÑùƷӦʹÓÃÓëÑо¿Ñù±¾»ùÖÊÏàËÆ£¬ÇÒ¾¡¿ÉÄÜÓëÆä½Ó½üµÄ»ùÖÊÀ´ÖƱ¸¡£ÀýÈ磬Èç¹ûÑо¿Ñù±¾ÊÇδ¹ýÂË¡¢Î´ÀëÐÄ»òδ¾»îÐÔÌ¿´¦ÀíµÄѪÇ壬ÔòQC»ùÖÊÒ²Ó¦ÊÇδ¹ýÂË¡¢Î´ÀëÐÄ»òδ¾»îÐÔÌ¿´¦ÀíµÄͬһÎïÖÖµÄѪÇ塣ӦʹÓÃδϡÊÍ£¨100%£©µÄ»ùÖÊÖÆ±¸QCÑùÆ·£¬ÒÔ±ã¶ÔQCÑùÆ·ÓëÑо¿Ñù±¾½ÓÄÉÏàͬµÄÏ¡ÊͰ취[Èç×îµÍÏ¡ÊͶȣ¨minimum required dilution£¬MRD£©]¡£µ«²»ÅųýÌØÊâÇé¿ö£¬ÀýÈçÓÃÌæ´ú»ùÖÊÈ¡´úÏ¡ÓеÄÑо¿»ùÖÊ£¨Í¨³£ºÜÄÑ»ñµÃ×ã¹»ÊýÁ¿µÄÏ¡ÓлùÖʰüÀ¨£ºÄÔ¼¹Òº¡¢ÊàŦǻ»¬Òº»òÀ´×ÔijЩÎïÖÖµÄÑÛ²¿»ùÖÊ£¨ocular matrices£©µÈ£©£¬µ«ÕâÐèÒªÊʵ±µÄÀíÓÉ£¬²¢ÇÒÖ»ÔÊÐíÔÚÐèÒª±£´æ»ùÖÊ£¨matrix conservation£©µÄÇé¿öÏÂʹÓ᣻º½â»ùÖÊÌåÁ¿ÎÊÌâµÄÍÆ¼öÒªÁìÊÇÔÚÌæ´ú»ùÖÊÖÐ×¼±¸3¸öQCˮƽÖеÄ2¸ö£¬¶øÔÚÑо¿»ùÖÊÖÐÖÆ±¸Ò»¸öŨ¶ÈµÄQC¡£Èç¹ûʹÓÃÌæ´ú»ùÖÊ£¬ÔòÐèÒªÖ¤Ã÷ÆäÓëÑо¿»ùÖʾßÓеÈЧÐÔ¡£×îºÃʹÓÃÓëÖÆ±¸±ê׼Ʒ£¨calibrators£©ÏàͬÅú´ÎµÄ»ùÖÊÀ´ÖƱ¸QCÑùÆ·£¬ÒÔÔöǿҪÁìµÄÒ»ÖÂÐÔºÍÖØÏÖÐÔ¡£ÖмäÔÒº£¨intermediate stock£©ÊÇÓÃÓÚÖÆ±¸QCÑùÆ·µÄ´ý²âÎïÈÜÒº£¬¿ÉÒÔÔÚÏÂÁÐÏ¡ÊͼÁÖÐÖÆ±¸£¬ÈçË®¡¢»º³åÒº»òÓлú½éÖÊ£¨organic media£©¡£µ±ÖмäÔÒºÊÇË®»ò»º³åҺʱ£¬QCµÄ×îÖÕÉí·ÖÖÁÉÙΪ95%£¨v/v£©µÄÑù±¾»ùÖÊ£»µ±Ê¹ÓÃÓлúÈܼÁ£¨ÈçDMSO»òÒÒËá£©ÖÆ±¸Ê±£¬×îÖÕÉí·ÖÖÁÉÙΪ99%£¨v/v£©µÄÑù±¾»ùÖÊ¡£QCsµÄ¶ÀÁ¢ÖƱ¸Ó¦µ±»®·ÖÖÆ±¸QCÑùÆ·Óë±ê׼Ʒ£¬ÒÔ±ÜÃâ¼ÓÈë´ý²âÎïʱµÄϵͳÐÔÎó²î¡£½¨ÒéʹÓòî±ðµÄÖмäÔÒººÍ²î±ðµÄÏ¡ÊͰ취À´ÖƱ¸QCÑùÆ·ºÍ±ê׼Ʒ£¬»¹½¨ÒéÔÚÿ¸öŨ¶ÈÖжÀÁ¢¼ÓÈë´ý²âÎ¶ø²»ÊÇͨ¹ýÐòÁÐÏ¡ÊÍ£¨serial dilutions£©¸ßŨ¶ÈµÄQCÑùÆ·¡£ÕâÒ»µãÓÈÎªÖØÒª£¬ÒòΪ±ê׼ƷÈç¹ûÊÇͨ¹ý¸ßŨ¶ÈÑùÆ·µÄÐòÁÐÏ¡ÊÍÖÆ±¸µÄ£¬ÐòÁÐÏ¡ÊÍQCÑùÆ·ºÍ±ê׼ƷÄܹ»ÑÚ¸ÇÏ¡ÊÍÏßÐԶȵÄÎÊÌ⣬Ӧ¸ÃÖÆÖ¹ÕâÖÖ²Ù×÷¡£±ê׼ƷÔÚQCÖÆ±¸Ê±£¬PK¶¨Á¿ÆÊÎöÖеıê׼Ʒ£¨reference standard£©»òADA¼ì²âÖеÄÑôÐÔ±ÈÕÕÆ·£¨positive antibody control£©±ØÐëÔÚÆäÓÐЧÆÚÄÚ¡£Ó¦¸Ãµ¥¶À½¨Á¢QCÑùÆ·µÄÎȶ¨ÐÔºÍÓÐЧÆÚ£¨ÓëÓÃÓÚÖÆ±¸µÄ±ê׼ƷÎ޹أ©£¬ÒòΪQCÑùÆ·ÖеĴý²âÎïÊÇÔÚ»ùÖÊÖ®ÖУ¬ÓëÔÒºÖеıê׼ƷÊDzî±ðµÄ¡£¿ÉÒÔÖÆ±¸¡¢·Ö×°ºÍÖü´æ½«±ê׼ƷÓÃÑо¿»ùÖÊ»òÊʵ±Ï¡ÊͼÁÏ¡ÊÍʱËù±¬·¢µÄÖмäÔÒº£¬ÒÔ¹©Î´À´ÖƱ¸QCÑùÆ·»ò±ê׼Ʒ¡£ÔÚÕâÖÖÇé¿öÏ£¬ÖмäÔÒºµÄÎȶ¨ÐÔÓ¦ÁýÕÖÆäÖü´æ´°¿ÚÆÚ£¬¼´´ÓÆäÖÆ±¸ÈÕÆÚÆðÖÁʹÓÃÈÕÆÚΪֹ¡£Õâ¿ÉÒÔͨ¹ý±È½ÏÏÂÊö2ÖÖÑùÆ·À´ÊµÏÖ£º1. ´Ó¶³´æµÄÖмäÔÒº£¨frozen intermediate stock£©ÖƱ¸µÄ±ê׼ƷºÍ/»òQCÑùÆ·£»2. ʹÓóõʼµÄ±ê׼ƷÔÒº£¨original reference standard stock£©ÖƱ¸µÄ±ê׼ƷºÍ/»òQCÑùÆ·¡£¼°¸ñ£¨Qualified£©»ùÖÊÕýÈ·µØÑ¡ÔñÓÃÓÚÖÆ±¸QCÑùÆ·µÄ»ùÖÊ£¬¹ØÓÚ°ü¹ÜÆÊÎöÒªÁìµÄÖÊÁ¿ºÍ±ÜÃâÆÊÎö½á¹ûÆ¯ÒÆÊÇÖÁ¹ØÖØÒªµÄ¡£ÕâÔÚADA¼ì²âÖÐÓÈÆäÖØÒª£¬ÒòΪ¼°¸ñµÄ»ùÖÊ£¨QMP£©£¬×÷ΪÒõÐÔ±ÈÕÕ£¨NC£©£¬½«Ö±½ÓÓ°Ïì΢¿×°åÌØÒìÐÔµÄÇе㣬±ØÐëÔÚÒÑÑéÖ¤µÄ¶¨Á¿ÆÊÎöÒªÁìÖлòÊʵ±µÄSOPÖУ¬½¨Á¢²¢Ã÷È·»®¶¨Êʵ±µÄ»ùÖÊɸѡ£¨screening£©¡¢Ñ¡Ôñ£¨selection£©Àú³ÌÒÔ¼°½ÓÊܱê×¼¡£ÓйػùÖÊÖÊÁ¿ÈÏÖ¤£¨qualification£©µÄ½¨Òé×ܽáÈçÏ¡£i. µÚÒ»¸ö»ùÖʵÄÖÊÁ¿ÈÏÖ¤µÚÒ»¸ö¼°¸ñ»ùÖʵÄÅú´ÎÈÏ֤ͨ³£ÊÇ×÷ΪÆÊÎöÒªÁ쿪·¢µÄÒ»²¿·Ö½øÐе쬲¢ÔÚÒªÁìÑé֤ʱ½øÐÐÕýʽµÄÈÏÖ¤¡£& ÈÏÖ¤×ã¹»ÌåÁ¿µÄ¼°¸ñ»ùÖÊ£¬×ãÒÔÔÚ¶à¸öÑо¿ºÍ¶à¸öÒ©Î↑·¢½×¶ÎһֱʹÓá£ÖÁÉÙ£¬ÓÐ×ã¹»ÌåÁ¿µÄ¼°¸ñ»ùÖÊ¿ÉÒÔÂú×ãÑо¿Ç°ÑéÖ¤ÒÔ¼°Ò»Ïî»ò¶àÏîÉúÎïÑùÌìÖ°ÎöÑо¿¡£& ¼°¸ñ»ùÖʵÄÖü´æÌõ¼þÓëÔ¤ÆÚÑо¿Ñù±¾µÄÖü´æÌõ¼þÒ»Ö£¨Èç-20¡æ»ò-80¡æ£©¡£& ÖÆ±¸»ìÏý»ùÖÊ£¨matrix pool£©µÄµÚÒ»²½£¬ÊÇͨ¹ý±È½ÏδÌí¼ÓºÍÌí¼ÓÁË´ý²âÎïµÄ»ùÖÊÑù±¾Ëù±¬·¢µÄÆÊÎöÐźţ¬À´É¸Ñ¡µ¥¸ö»ùÖÊÑù±¾»ò»ìÏý»ùÖÊÑù±¾£¨¶à¸ö¡¢µ¥¸öÑù±¾µÄ»ìÏýÎ¡£& ×÷ΪÅä¾°Öµ£¬¿¼²ìδÌí¼Ó´ý²âÎïµÄ»ùÖÊÑù±¾µÄÏìÓ¦Öµ¡£Ó¦µ±½«Åä¾°Òì³£¸ßµÄ»ùÖÊÑù±¾ÌÞ³ý£¬ÀýÈ磬¸ßÓÚPK¶¨Á¿ÏÂÏÞ£¨LLOQ£©»ò¸ßÓÚADAÔ¤¹ÀÇеãµÄÑù±¾¡£¹ØÓÚADAÆÊÎö£¬Åä¾°Òì³£µÍÒ²¿ÉÄÜÓÐÎÊÌâ¡£& ¹ØÓÚPK¶¨Á¿ÆÊÎö£¬¿Éƾ¾ÝÆÊÎöÒªÁì»òʵÑéÊÒSOPÖÐÈ·¶¨µÄ½ÓÊܱê×¼À´ÆÀ¹ÀÌí¼ÓÁË´ý²âÎïµÄ»ùÖÊÑù±¾¡£È罨ÒéÏà¶ÔÎó²î£¨RE£©µÄ½ÓÊܱê×¼ÔÚ±20%¹æÄ£ÄÚ£»½¨ÒéÔÚLLOQºÍµÍQC(LQC)Ö®¼äµÄŨ¶ÈˮƽÉÏÌí¼Ó´ý²âÎïµ½µ¥¸ö»ùÖÊÑù±¾£¬²¢ÇÒÖÁÉÙÔÚÒ»´ÎÆÊÎöÔËÐÐÖÐÕâÑù×ö¡£& ¹ØÓÚADAÆÊÎö£¬±ØÐëÇ¿µ÷¿Õ°×Ðźţ¨blank signal£¬NC£©µÄÖØÒªÐÔ¡£µ±Ã»ÓÐÆäËüÅú´ÎµÄ»ùÖʿɱȽÏʱ£¬½¨ÒéÔÚɸ²é²âÊÔ(screen£¬Tier 1)ÖÐÆÀ¹Àµ¥¸ö»ùÖÊÑù±¾£¬²¢±È½Ï×éÄÚ¸÷¸öÑù±¾µÄÏìÓ¦Öµ£¬ÒÔÆÀ¹ÀÆäÔʼÏìÓ¦Öµ¡£Ó¦½«ËùÓÐÒì³£¸ßÏìÓ¦Öµ»òµÍÏìÓ¦ÖµµÄµ¥¸ö»ùÖÊÅųýÔÚÌæ»»»ìÏý»ùÖÊ£¨replacement matrix pool£©Ö®Íâ¡£ÔÚ¿ÉÄܵÄÇé¿öÏ£¬»¹Ó¦½«»ìÏý»ùÖÊ£¨matrix pool£©ÓëÒ»×é¼²²¡×´Ì¬µÄ»ùÖÊÑù±¾½øÐбȽϣ¬ÒÔÈ·¶¨ÆäÊÊÓÃÐÔ£¨suitability£©¡£& ¹ØÓÚPK¶¨Á¿ÆÊÎö£¬»ìÏý»ùÖʵÄÅä¾°µÄ½ÓÊܱê×¼£¬¿ÉÒÔÊDZÈÔ¤¹ÀµÄLLOQµÍ2-3±¶µÄ»ùÖÊÏìÓ¦¡£ADAÆÊÎöµÄ½ÓÊܱê×¼£¬¿ÉÒÔÊǵÍÓÚÔ¤¹ÀµÄÇеã»òÔÚÌØ¶¨µÄÏìÓ¦¹æÄ£ÄÚ¡£ii. Ìæ»»»ùÖÊÅú´ÎµÄÖÊÁ¿ÈÏÖ¤& ʹÓÃÓëÈÏÖ¤µÚÒ»Åú´ÎÏàͬµÄÆÊÎöÒªÁ죬¶ÔÌæ»»Åú´ÎµÄ»ùÖÊÑù±¾½øÐÐÈÏÖ¤¡£¨CÈ·±£Î´Íâ¼Ó´ý²âÎïµÄÏÖÓеĺÍÌæ»»µÄ¼°¸ñ»ùÖÊ£¨QMP£©µÄÏìÓ¦Öµ¾ßÓпɱÈÐÔ¡£¨C¹ØÓÚPK¶¨Á¿ÆÊÎö£¬Ó¦µ±½«Ìæ»»»ùÖÊÅú´ÎÓëÏÖÓм°¸ñÅú´Î½øÐбȽϡ£ÖÁÉÙÔÚÒ»´ÎÆÊÎöÔËÐÐÖУ¬ÆÊÎöÌí¼ÓÁË´ý²âÎï±ê׼ƷµÄÑù±¾£¨Å¨¶ÈÔÚLLOQºÍLQCÖ®¼ä£¬ÖÁÉÙn=3£©¡£±ê׼Ʒ£¨reference standard£©µÄÆÊÎö½ÓÄÉÂÊ(AR)£¬ÔÚÏÖÓкÍÌæ´úÅú´ÎµÄ»ùÖÊÖУ¬¶¼Ó¦ÔÚ80ÖÁ120%µÄ¹æÄ£ÄÚ¡£Í¬Ê±£¬Ê¹ÓÃÁ½¸ö»ùÖÊÅú´ÎÖÆ±¸µÄÑù±¾Ëù²â¶¨µÄ±ê׼ƷŨ¶ÈÖ®²î²»Áè¼Ý10%¡£¨CΪÁËÈÏÖ¤ADAÆÊÎöÖеÄÌæ»»¼°¸ñ»ùÖÊ£¨replacement QMP£©£¬Ó¦µ±Ê¹ÓÃÏÈǰ½¨Á¢µÄ΢¿×°åÌØÒìµÄÇеãÒò×Ó£¬¶Ôµ¥¸ö»ùÖÊÑù±¾½øÐÐɸ²é¡£É¸²é²âÊÔÖÐÊÇÑôÐÔµÄËùÓе¥¸öÑù±¾¶¼Ó¦ÅųýÔÚÌæ»»¼°¸ñ»ùÖÊÖ®Íâ¡£ÁíÒ»ÖÖÒªÁìÊÇÖ±½Ó¿¼²ìÿ¸ö»ùÖÊÑù±¾µÄÐÅÔë±È(S/N)£¬Ó¦½«Áè¼Ý¾¹ýÑéÖ¤µÄÇеãÒò×ӵĻùÖÊÑù±¾ÅųýÔÚÌæ»»¼°¸ñ»ùÖÊÖ®Íâ¡£ÒÔÏÂÍÆ¼öµÄÊÇÌæ»»¼°¸ñ»ùÖʵĽÓÊܱê×¼: Ìæ»»»ùÖÊÅú´ÎµÄÏìÓ¦Öµ£¬Ó¦µ±ÔÚÏÖÓлùÖÊÅú´ÎÏìÓ¦ÖµµÄ±10%ÒÔÄÚ¡£Èç¹û²»ÊÇ£¬ÔòÓ¦µ±ÆÀ¹ÀÒ»×éµ¥¸ö»ùÖÊÑù±¾£¬²¢ÓëÁ½¸ö΢¿×°åÌØÒìµÄÇеã±È½Ï£¬ÒÔÈ·¶¨É¸²é½á¹ûÊÇÑôÐÔ»òÒõÐÔ¡£ÆäÖÐÒ»¸öÇеãÊÇÓÃÏÖÓм°¸ñ»ùÖʵÄÒõÐÔ±ÈÕÕÅÌËãµÄ£¬ÁíÒ»¸öÇеãÊÇÓÃÌæ»»¼°¸ñ»ùÖÊÖÆ±¸µÄÒõÐÔ±ÈÕÕÅÌËãµÄ¡£Ê¹ÓÃÕâÁ½¸öÇе㣨ÏÖÓÐvs.Ìæ»»Î¢¿×°åÌØÒìµÄÇе㣩ËùµÃ³öµÄɸ²é½á¹û£¨ÒõÐÔ/ÑôÐÔ״̬£©Ó¦µ±ÏàËÆ£¨comparable£©£¬µ«borderline samples£¬Æ¾¾Ý»ùÖÊÏìÓ¦£¬¿ÉÄÜÊÇÑôÐÔ»òÒõÐÔ¡£iii. »ùÖʵÄÅä¾°ÏìÓ¦ÔÚPKÆÊÎöÖУ¬»ùÖʵÄÅä¾°ÏìÓ¦Ó¦¼á³ÖÔÚ×îµÍ״̬£¬ÒòΪËüÓ°ÏìÆÊÎöÁéÃô¶È£¬²¢¿ÉÄÜÏÞÖÆ¶¨Á¿µÄ¹æÄ£¡£¹ØÓÚADAÆÊÎö£¬½¨ÒéÒ»µ©»ñµÃÑéÖ¤Êý¾Ý£¬¾ÍÓ¦¾¡¿ìÈ·¶¨»ùÖÊÏìÓ¦¹æÄ£µÄÉÏÏÞºÍÏÂÏÞ¡£& ÔڷǾºÕùÐÔ¶¨Á¿£¨ÈçPK£©ÃâÒß²âÊÔÖУ¬»ùÖÊÅä¾°²»Ó¦Áè¼ÝLLOQµÄ1/3¡£& ÔÚ¾ºÕùÐÔÃâÒ߯ÊÎöÖУ¬Åä¾°ÖµÖÁÉÙΪ×îµÍУ׼µãÊýÖµµÄ1.11±¶¡£ÕâÊÇ»ùÓÚB/B0£¨×îµÍУ׼µãÐźÅ/ÁãУ׼µãÐźţ¬lowest calibrator signal/zero calibrator£©½¨ÒéµÄ90%£¨100/90£©¡£& ÔÚADAºÍÆäËû·Ç¶¨Á¿ÆÊÎöÖУ¬¶Ô»ùÖÊÅä¾°µÄÒ»°ã½¨ÒéÊÇÏà¶Ô·¢¹âµ¥Î»£¨RLUs£©¡Ü200ºÍÎü¹â¶È¡Ü0.200¡£ÓÐЩ²âÊÔÒªÁìµÄ»ùÖÊÅä¾°Ôò±ÈÉÏÊö½¨ÒéµÄÒª¸ß¡£& »ùÖÊÅä¾°µÄÏÂÏÞÓÉÒÇÆ÷ÏìÓ¦¾ö¶¨£¬²î±ðÒÇÆ÷ºÍ²î±ðʵÑéÊÒµÄÒÇÆ÷ÏìÓ¦¿ÉÄܲî±ð¡£É豸& ÓÃÓÚÖÆ±¸QCÑùÆ·µÄÉ豸£¬°üÀ¨ÒÆÒºÆ÷£¬Ó¦½øÐо«ÃܶÈÑéÖ¤£¬²¢Ó¦ÔÚУ׼¹æÄ£ÄÚ¡£& É豸У׼µÄÀú³ÌºÍƵÂÊÓ¦ÔÚSOPÖл®¶¨Ã÷ʾ¡£& ÔÚһЩʵÑéÊÒ£¬³ýÁ˰´ÆÚУ׼֮Í⣬»¹ÐèÒªÔÚʹÓÃÒÆÒºÆ÷ÖÆ±¸QCÑùƷ֮ǰ½øÐÐÌØÁíÍâУ׼¼ì²é£¬µ«ÔÚһЩʵÑéÊÒ£¬Èç¹û°´ÆÚУ׼ÈÔÈ»ÓÐЧ£¬Ôò²»ÐèÒªÖØÐ½øÐÐУ׼¼ì²é¡£3.QCÑùÆ·µÄÈÏ֤ͨÀýµÄÔËÐнÓÊܱê×¼£¨general run acceptance criteria£©´Ë´¦µÄÒ»°ãÔËÐнÓÊܱê×¼ÊÊÓÃÓÚÏÖÓкÍÌæ»»QCÅú´ÎµÄÈÏÖ¤¡£´Ë´¦ÏÂÁÐÊõÓ»ùÏßÅú´Î£¨baseline QC lots£©¡¢ÒÅÁôQCÅú´Î£¨legacy lots£©»òQC±È½ÏÅú´Î£¨comparator QC lots£©¿É½»»»Ê¹Ó᣹ØÓÚPK¶¨Á¿ÆÊÎöÒªÁì1. QCÑùÆ·¿ÉÓë֮ǰÈÏÖ¤¹ýµÄ£¬ÇÒÓÐÒÑÖªÎȶ¨ÐԵͳ´æÐ£×¼Æ·½øÐбȶԺÍÈÏÖ¤¡£Èç¹ûûÓм°¸ñµÄ¶³´æ±ê׼Ʒ£¬ÔòӦʹÓÃÖØÐÂÖÆ±¸µÄ±ê×¼ÇúÏß¶ÔQCÑùÆ·½øÐÐÆÀ¹À¡£ÔÚºóÒ»ÖÖÒªÁìÖУ¬ÐèÒª¼ÓÈë֮ǰÈÏÖ¤¹ýµÄÒ»×éQCÑùÆ·¶ÔÐÂÏÊÖÆ±¸µÄ±ê×¼ÇúÏß½øÐÐÈÏÖ¤¡£2. ÈÏÖ¤£¨qualification£©ÊÇͨ¹ýÆÀ¹ÀÆÊÎöÄÚºÍÆÊÎö¼äµÄ¾«Ãܶȣ¨inter- and intra-assay precision£¬¶ÔËùÓÐÒªÁ죩ºÍ׼ȷ¶È(¶Ô¶¨Á¿ÒªÁì)À´½øÐеġ£3. ¶Ô¶¨Á¿ºÍÒ©´ú¶¯Á¦Ñ§ÆÊÎöÒªÁ죬QCÑùÆ·±ØÐëÂú×㾫ÃܶȺÍ׼ȷ¶È±ê×¼£º±äÒìϵÊý(coefficient of variation£¬CV) ¡Ü20%£¬REÔÚ±20%Ö®ÄÚ£»¶¨Á¿ÏÂÏÞ£¨LLOQ£©ºÍÉÏÏÞ£¨ULOQ£©£ºCV¡Ü25%£¬REÔÚ±25%Ö®ÄÚ¡£¹ØÓÚADAºÍÆäËü¶¨ÐÔÆÊÎöÒªÁ죺1. QCÑùÆ·Ó¦Âú×ãCV¡Ü20%µÄ±ê×¼¡£2. ÏÖÓкÍÌæ»»QCµÄÏìÓ¦Öµ¶¼Ó¦ÔÚÆäÏàӦŨ¶È¼¶±ðÒѽ¨Á¢µÄÏìÓ¦¹æÄ£ÄÚ¡£Èç¹ûÌæ»»µÄQCÅú´Î²»ÔÚÏàÓ¦µÄÐźŹæÄ£ÄÚ£¬ÔòʵÑéÊÒ±ØÐëÅųý¹ÊÕϲ¢È·¶¨Æä»ù´¡ÔÒò¡£ADAÑôÐÔ±ÈÕÕ£¨PC£©ºÍÒõÐÔ±ÈÕÕ£¨NC£©ÐÅºÅÆ¯ÒƵÄDZÔÚÔÒò°üÀ¨£º(a)´ý²âÎïÌí¼Ó¹ýʧ£»(b) »ìÏý»ùÖÊÑ¡Ôñ²»µ±£»(c)ÐźŹæÄ£É趨²»ÕýÈ·¡£ºóÐøµÄ¹ÊÕÏÅųýÓ¦×ñÑÒÔÏÂ˳Ðò: Ê×ÏÈ×¼±¸Ò»¸öÐÂÅú´ÎµÄQCÑùÆ·£¬Èç¹ûÖØ¸´ÖƱ¸µÄQCÈÔȻʧ°Ü£¬ÔòÈÏÖ¤Ò»¸öÐÂÅú´ÎµÄ¼°¸ñ»ùÖÊ£¨QMP£©£»È»ºóÖØÐÂÖÆ±¸ÑôÐÔºÍÒõÐÔ±ÈÕÕ£¬Èç¹ûÐÂÖÆ±¸µÄÑôÐÔºÍÒõÐÔ±ÈÕÕÈÔÈ»ÔÚÆäÐźŹæÄ£Ö®Í⣬ÔòÄÉÈëÑо¿ÖвâÊÔÔËÐеóöµÄÌØ±ðÊý¾Ý£¬½ø¶øÖØÐÂÆÀ¹ÀÒѽ¨Á¢µÄÐźŹæÄ£¡£Ã¿¸öʵÑéÊÒÓ¦µ±Æ¾¾Ý×ã¹»µÄ²âÊÔÔËÐдÎÊýËùµÃ³öµÄÊý¾Ý£¬ÊÊÍâµØÈ·¶¨ÑéÖ¤ºóÐźŹæÄ££¬ÒÔÖÆÖ¹½«Æä¹æÄ£ÉèÖõùýÕ»òÕß²»ÊʺϺã¾ÃʹÓá£3. ½ÓÊܱê×¼£º¸ßÑôÐÔ±ÈÕÕ£¨HPC£©>µÍÑôÐÔ±ÈÕÕ£¨LPC£©>Çеã>ÒõÐÔ±ÈÕÕ¡£¹ØÓÚËùÓÐÆÊÎöÒªÁì1. ½¨ÒéÔÚÿ´ÎÈÏÖ¤µÄ²âÊÔÔËÐÐÖУ¬ÖÁÉÙ²âÊÔ3×éÏÖÓкÍÌæ»»QCÑùÆ·¡£ÔÚÕâ¸öÒªÇóÉÏ£¬¸öÌåʵÑéÊÒ¿ÉÄÜ»áÓÐËù²î±ð¡£2. ÖÁÉÙÈý·ÖÖ®¶þµÄ²âÊÔÔËÐÐÓ¦Âú×ãÉÏÊö»®¶¨µÄ½ÓÊܱê×¼¡£ÕâЩÈÏÖ¤ÒªÇóºÍ½¨Òé¼û±íI¡£±í1. Ìæ»»QCÅú´Î£¨replacement QC lots£©ÈÏÖ¤ÒªÇóµÄ±È½Ï3. ÏÖÓеĺÍÌæ»»µÄQCÑùÆ·±ØÐëÂú×ãÉÏÊöµÄͨÀýÔËÐнÓÊܱê×¼¡£4. Èç¹ûÌæ»»Åú´ÎµÄQCÑùÆ·²»ÇкÏÉÏÊö½ÓÊܱê×¼£¬¶øÏÖÓÐÅú´Î¼°¸ñʱ£¬ÔòÓ¦½«Ìæ»»Åú´ÎÆÆ³ý£¬²¢ÖƱ¸ÁíÒ»Åú´ÎµÄQCÑùÆ·¡£µ±Ò»¸öŨ¶ÈˮƽµÄÌæ»»QCÑù±¾È±·¦¸ñʱ£¬¿ÉÒÔÖØÐÂÖÆ±¸¸ÃŨ¶ÈˮƽµÄQC¡£5. Èç¹ûÏÖÓеÄQCÅú´ÎÔÚÌæ»»Åú´ÎµÄÈÏÖ¤Àú³ÌÖÐδÄÜͨ¹ý½ÓÊܱê×¼£¬ÔòÓ¦ÖØÐÂÆÊÎöÒÔÈ·ÈÏÏà¹Ø½á¹û¡£Èç¹ûÏÖÓеÄÅú´ÎÔÚÖØ¸´ÆÊÎöºóÈÔȻȱ·¦¸ñ£¬ÄÇôËü¾Í²»¿ÉÓÃ×÷±È¶ÔÆ·£¨comparator£©¡£ÔÚÕâÖÖÇé¿öÏ£¬Ó¦×ñÑ<ÏÖÓм°¸ñÅú´Î²»±£´æÊ±µÄÈÏÖ¤>Õ½ÚËùÃèÊöµÄ³ÌÐòºÍÖÊÁ¿±ê×¼¡£µÚÒ»¸öÅú´ÎQCÑùÆ·µÄÖÊÁ¿ÈÏÖ¤µÚÒ»¸öÅú´ÎµÄQCÑùÆ·£¬Ò²±»³ÆÎª»ùÏߣ¨baseline£©»òÒÅÁô£¨legacy£©Åú´Î£¬Í¨³£×÷ΪÑо¿Ç°ÒªÁìÑéÖ¤ÖеÄ׼ȷ¶ÈºÍ¾«Ãܶȣ¨A&P£©ÆÀ¹ÀµÄÒ»²¿·Ö½øÐÐÈÏÖ¤¡£¶ÔÑо¿Ç°ÒªÁìÑéÖ¤ÖеÄQCÅú´Î½øÐÐÈÏ֤ʱ£¬ÍƼöÖÁÉÙ½øÐжÀÁ¢ÔËÐÐ6´Î£¬Ã¿¸öQCŨ¶ÈÖÁÉÙÔËÐÐ3´Î£¬ÖÁÉÙ·Ö2Ìì½øÐУ¬ÖÁÉÙ2ÃûÆÊÎöÈËÔ±¼ÓÈë¡£ÇÒÒªÇóÖÁÉÙ4/6µÄQCÈÏÖ¤ÔËÐÐÓ¦¸ÃÂú×ã½ÓÊܱê×¼£¬²ÅÂú×ã¶Ô¸ÃÅú´ÎQCÈÏÖ¤£¨¼û±í1£©¡£ÔÚ¿ÉÄܵÄÇé¿öÏ£¬»¹½¨Ò齫¸ÃQCÅú´ÎÓëÒªÁ쿪·¢Ê±ËùÓõÄQCÑùÆ·½¨Á¢ÇŽÓÁªÏµ¡£¶ÔÕâÖÖÇŽÓÐÔÆÀ¼ÛµÄ½ÓÊܱê×¼½«Óɸ÷¸ö¶ÀÁ¢µÄʵÑéÊÒ×ÔÐÐÖÆ¶¨£¬ ÍÆ¼ö¶þÕßÖ®¼äµÄÎó²îΪ±10%»ò¸üµÍ¡£Ìض¨ÑùÆ·µÄÔËÐнÓÊܱê×¼±ØÐëÂú×ãͨÀýÔËÐнÓÊܱê×¼¡£±í1. Ìæ»»QCÅú´Î£¨replacement QC lots£©ÈÏÖ¤ÒªÇóµÄ±È½Ï¡£Ìæ»»Åú´ÎQCÑùÆ·µÄÈÏÖ¤i. ͨ¹ýÓëÏÖÓм°¸ñQCÅú´Î±È½ÏµÄÈÏÖ¤ÔÚÑо¿Ç°µÄÒªÁìÑéÖ¤Ö®Í⣬ÿ´ÎÖÆ±¸Ìæ»»Åú´ÎQCÑùƷʱ£¬Í¨¹ýÓë֮ǰÈÏÖ¤Á˵썼°¸ñ£©Åú´ÎµÄ±È½Ï£¬¶ÔÌæ»»Åú´Î½øÐÐÈÏÖ¤¡£ÎªÁ˿ɿ¿µØ½øÐпɱÈÐÔÆÀ¹À£¬±ØÐëʹÓÃÏàͬµÄ¶³´æ»òÐÂÏÊÖÆ±¸µÄ±ê×¼ÇúÏßÀ´ÆÀ¹ÀÏÖÓеĺÍÌæ»»µÄQCÅú´Î¡£Ò»¸öÌæ»»Åú´ÎµÄQCÑùÆ·ÖÁÉÙÒª¾¹ý2¸ö¶ÀÁ¢µÄÈÏÖ¤ÔËÐУ¨qualification runs£©¡£QCÈÏÖ¤ÔËÐпÉÄÜÔÚͬһÌìÓɶà¸öÆÊÎöÈËÔ±£¨ÖÁÉÙ2Ãû£©£¬»òͬһÆÊÎöÈËÔ±ÔÚ²î±ðÌ죨ÖÁÉÙ2Ì죩½øÐС£½¨ÒéÔÚͬһÈÏÖ¤ÔËÐÐÖУ¬ÖÁÉÙÒª°üÀ¨3×é¶ÀÁ¢µÄÌæ»»Åú´ÎQCÑùÆ·ºÍÖÁÉÙ3×éÏÖÓÐÅú´ÎµÄQCÑùÆ·¡£Ò»×é´Óµ¥¶À¶³´æºÍ·Ö×°µÄQCËùÖÆ±¸µÄÑùÆ·±»½ç˵Ϊһ×é¶ÀÁ¢µÄQCÑùÆ·£¨Ò»×éÓÐÈý¸öŨ¶È¼¶±ð£©¡£ÔÚQCÈÏÖ¤Àú³ÌÖУ¬²»ÃãÀøÔÚͬһ²âÊÔÔËÐÐÖÐʹÓÃͬһ¶³´æºÍ·Ö×°µÄQCÖÆ±¸µÄÒ»×éQC¡£¸öÌåʵÑéÊÒ¿ÉÒÔÖÆ¶¨²î±ðÓÚ´Ë´¦½¨ÒéµÄ±ê×¼£¬ÈçÆ¾¾ÝÆä¶ÔËùÉæ¼°µÄ±äÒìÐÔºÍΣº¦µÄÆÀ¹À£¬»®·Ö½øÐÐ3´Î¶ÀÁ¢²âÊÔÔËÐУ¬¶ø²»ÊÇ2´Î¡£¶¨Á¿LBAÒªÁìÖУ¬Ìæ»»QCÅú´ÎµÄÈÏÖ¤£¬Ó¦µ±ÒÔͨÀýÔËÐнÓÊܱê×¼ÖеĻ®¶¨Îª»ù´¡£¬Í¬Ê±Ò²Ó¦µ±ÒÔÆäÓëÏÖÓм°¸ñQCÅú´ÎµÄ¿É±ÈÐÔ£¨comparability£©Îª»ù´¡¡£ÀýÈ磬¿É±ÈÐÔ±ê×¼¿É°üÀ¨ÏÖÓÐÅú´ÎºÍÌæ»»Åú´ÎÖ®¼ä±10%»òÒÔϵIJî±ð¡£Ê¹ÓÃÏÖÓкÍÌæ»»QCÑùÆ·µÄÕÉÁ¿Å¨¶È£¬¿ÉÒÔÓÃÏÂÃæµÄ¹«Ê½È·¶¨²î±ð°Ù·Ö±ÈÖµ£¨%£©¡£Ìæ»»Åú´ÎŨ¶È-ÏÖÔÚÅú´ÎŨ¶ÈÓÃÓÚADAºÍÆäËû·Ç¶¨Á¿LBA¼ì²âÒªÁì, ÏÖÓкÍÌæ»»µÄQCÅú´Î¶¼Ó¦¸ÃÂú×ãADAºÍ¶¨ÐÔÆÊÎöµÄͨÀýÔËÐнÓÊܱê×¼¡£±ðµÄ£¬ÏÖÓкÍÌæ»»PCsºÍNCsµÄÏìÓ¦¶¼Ó¦¸ÃÔÚ¸÷×Ô½¨Á¢µÄÐźŹæÄ£ÄÚ¡£ii. ²»±£´æÏÖÓм°¸ñ£¨ÈÏÖ¤¹ýµÄ£©QCÅú´ÎÇé¿öϵÄÈÏÖ¤¿ÉÄܱ£´æÕâÑùµÄÇé¿ö£¬¼´¿ÉÄܲ»±£´æÒÅÁôµÄ£¬¾ÈÏÖ¤¼°¸ñµÄQCÑùÆ·£¬ÒòΪÕâЩQCÑùÆ·ÒѾÓÃÍê»òÓâÆÚ¡£²»±£´æ¿É±È½ÏQCµÄÇé¿öÏ£¬½¨ÒéʹÓòî±ðµÄÖмäÔÒº£¨intermediate stocks£©£¬Óɲî±ðµÄÆÊÎöÈËÔ±£¬»®·ÖÖÆ±¸Á½¸öÅú´ÎµÄQCÑùÆ·¡£´Óʵ¼Ê²Ù×÷ÉÏ£¬¿ÉÒÔÖ¸¶¨Ò»¸öÅú´Î£¬¿ÉÄÜÊÇÅúÁ¿½Ï´óµÄ£¬ÎªÖ÷ÒªÅú´Î£¨primary lot£©£»ÁíÒ»Åú´Î£¬¿ÉÄÜÊÇСÅúÁ¿µÄ£¬¾Í×÷Ϊ²ÎÕÕÆ·£¨comparator£©£¬¶ÔÖ÷ÒªÅú´Î½øÐÐÈÏÖ¤¡£¶ÔÖ÷ÒªºÍ´ÎÒªÅú´ÎµÄ±ÈÕÕ²âÊÔÓ¦ÓÉ2È˽øÐУ¬Ã¿ÈËʹÓöÀÁ¢ÖƱ¸µÄ±ê×¼ÇúÏß½øÐвâÊÔ£¬Ã¿È˽øÐÐ3´Î²âÊÔ£¬ÖÁÉÙ·Ö2Ìì½øÐУ¬×ܹ²ÔËÐÐ6´Î¡£ÖÁÉÙ4/6 (2/3)µÄQCÈÏÖ¤ÔËÐÐÓ¦¸ÃÂú×ã½ÓÊܱê×¼¡£Ò²Ó¦Âú×ãÉÏÊöµÄͨÀýÔËÐнÓÊܱê×¼¡£Á½¸öÌæ»»Åú´ÎµÄQCÑùÆ·Ó¦Âú×ã±10%»ò¸üÑϸñµÄÆ«²î±ê×¼£¬°ü¹Ü¶þÕßÖÐÈκÎÒ»¸öÅú´Î¾ù¿É½ÓÊÜ¡£±í1×ܽáÁËÕâЩÈÏÖ¤ÒªÇó¡£ÔÚº¬ÓÐÄÚÔ´ÐÔ´ý²âÎïµÄ»ùÖÊÖÐÖÆ±¸µÄQCµÄÈÏÖ¤ÔÚ¶¨Á¿PKÆÊÎöÖУ¬µ±»ùÖÊÖк¬Óдý²âÎïµÄÄÚÔ´ÐÔͬԴÎïʱ£¬Ëù²â¶¨µÄ¿Õ°×»ùÖÊŨ¶È¿ÉÄÜÊÇÖÁ¹ØÖØÒªµÄ£»²¢Ó¦¸ÃÄÉÈ뿼ÂÇ¡£ÓÐ2ÖÖ·½·¨£º1.¼õ·¨£ºÔÚ±¨¸æ²â¶¨µÄQCֵ֮ǰ£¬´Ó²â¶¨µÄQCÑùƷŨ¶ÈÖмõÈ¥¿Õ°×»ùÖʵÄŨ¶È£»2.¼Ó·¨£º½«²â¶¨µÄ¿Õ°×»ùÖÊŨ¶È¼ÓÉÏQCµÄÍâ¼Ó´ý²âÎïŨ¶È£¬ÒÔÈ·¶¨Æäµ÷½âºóµÄ±ê³ÆÖµ¡£MarcellettiµÈÈ˽éÉÜÁ˼¸¸ö°¸ÀýÑо¿£»ÆäÖУ¬Ê¹Óüӷ¨ºÍ¼õ·¨£¬Ö±½Ó±È½ÏÁ˼ӱê½ÓÄÉÂÊ£»ÕâЩ°¸ÀýÑо¿ÆÀ¹ÀÁ˾ßÓÐÃ÷ÏÔÄÚÔ´ÐÔˮƽµÄÐí¶àÉúÎï±ê¼ÇÎïµÄ½ÓÄÉÂÊ¡£Æ¾¾ÝÕâЩÒÑÐû²¼µÄ°¸ÀýÑо¿£¬¼õ·¨ÊÇÊ×ѡҪÁ죬¶ø²»ÍƼöʹÓüӷ¨¡£½¨ÒéÔÚÿ¸öÈÏÖ¤ÔËÐÐÖÐÖÁÉÙ°üÀ¨3×é¿Õ°×»ùÖÊÑù±¾£¬Æä²â¶¨µÄƽ¾ùŨ¶ÈÓÃÓÚµ÷½âÖµ£¨adjusted value£©µÄÅÌËã¡£½¨Òé¶Ôº¬ÓÐÄÚÔ´ÐÔ´ý²âÎïµÄQCÑùÆ·£¬ÔÚ10-20ÌìÄÚÖÁÉÙ½øÐÐ30´ÎÔËÐУ¬ÖÁÉÙÓÐ2È˼ÓÈ룬ÿ¸öÔËÐÐʹÓáÝ3×éQCÑùÆ·¡£´ËÀàQCÈÏÖ¤µÄÔËÐнÓÊܱê×¼Ó붨Á¿PKÒªÁìµÄͨÀýÔËÐнÓÊܱê×¼Ïàͬ¡£Î´Öª±ê³ÆÅ¨¶È£¨Nominal Concentration£©µÄQCµÄÈÏÖ¤Èç¹ûQCÔÒºµÄ±ê³ÆÅ¨¶Èδ֪£¬Èçδ´¿»¯µÄÂѰ×ÖʺÍһЩÉÌÒµÀ´Ô´µÄ±ÈÕÕÔÒº£¨commercial control stocks£©£¬»òÕßÔÚѪҺѧ¼ì²âÖУ¬µ±crudeѪÇå/Ѫ½¬±»ÓÃ×÷ѪҺÒò×ÓµÄÀ´Ô´Ê±£¬±ê³ÆÅ¨¶È±ØÐëÆ¾¾Ý¶àλÆÊÎöÈËÔ±ÔÚ²î±ðÈÕÆÚ½øÐеĶà´ÎÔËÐÐÖмì²âµ½µÄƽ¾ùÖµÀ´È·¶¨¡£´ËÀà²âÊÔµÄÊʵ±¹æ·¶ÊÇÌØÒìÓÚ²âÊÔÒªÁìµÄ£¬±ØÐë×÷ΪÑо¿Ç°²âÊÔÒªÁìÑéÖ¤µÄÒ»²¿·Ö½¨Á¢ÆðÀ´¡£QCÑùÆ·µÄÖÆ±¸ÒªÁìÊǽ«´ý²âÎïÔÒº£¬ÒÔÌØ¶¨Ï¡Êͱ¶Êý£¬¼ÓÈëµ½¾¹ýÈÏÖ¤£¨¼°¸ñ£©µÄ¿Õ°×»ìÏý»ùÖÊ»òÊʵ±µÄÏ¡ÊͼÁ£¨diluent£©ÖС£¹ØÓÚËùÓÐÀֳɵÄÔËÐУ¬Ã¿¸öQCµÄƽ¾ù²â¶¨Öµ¾ÍÓ¦É趨Ϊ±ê³ÆÖµ¡£½¨ÒéÖÁÉÙÕý³£ÊµÊ©²âÊÔÔËÐÐ30´Î£¬ÓÉÖÁÉÙ2ÈËÔÚ10-20ÌìÄÚÖ´ÐУ¬ÒÔÉ趨QCÑùÆ·µÄ±ê³ÆÅ¨¶È¡£Ã¿¸ö²âÊÔÔËÐаüÀ¨ ¡Ý3 ×éQC¡£ÔÚ×î³õµÄ²â¶¨Ö®ºó£¬ÈÕ³£ÆÊÎöÔËÐÐÖÐQCÑùÆ·µÄ½ÓÊܱê×¼ÒÔ¼°½«À´Ìæ»»QCÅú´ÎµÄ½ÓÊܱê׼ΪÒÑÈ·¶¨µÄ±ê³ÆÖµ£¨nominal value£©µÄ±20%¡£ÈκÎÌæ»»Åú´ÎµÄ´ý²âÎïŨ¶È±ØÐëÔÚ´ËÈ·¶¨µÄ¹æÄ£ÄÚ¡£ÓÉÓÚÀ´×ÔѪÇåºÍѪ½¬µÄÒò×ӵĹÌÓеıäÒìÐÔ£¬¿ÉÄÜÐèÒª£¬»ùÓÚ×î³õµÄ20-30´ÎµÄÔËÐÐÊý¾Ý£¬ÎªÃ¿¸öQCŨ¶Èˮƽָ¶¨Ò»¸öÁÙʱµÄ±ê³ÆÖµ£»È»ºó£¬ÔÚÓÐÆäËü¿ÉÓÃÊý¾Ýʱ£¬ÖØÐÂÆÀ¹ÀÕâ¸ö±ê³ÆÖµµÄÊÊÓÃÐÔ¡£Èç¹û²âÊÔÒªÁìµÄÄÚÔÚ±äÒìÐԽϴó£¬Ôò¿ÉÄÜÐèÒª°´ÆÚµØÖØÐÂÆÀ¹ÀºÍÖØÐ½¨Á¢QCµÄ½ÓÊܹæÄ£¡£Ç°ÊöµÄPK¶¨Á¿ÒªÁìµÄͨÀýÔËÐнÓÊܱê×¼Ò²±ØÐë»ñµÃÂú×ã¡£±ê³ÆÅ¨¶ÈÓë²â¶¨Å¨¶Èµ¥Î»·×ÆçÖµÄQCµÄÈÏ֤ø»îÐÔ²âÊÔÒªÁìÊÇQC±ê³ÆÖµºÍ²â¶¨Öµµ¥Î»²î±ðµÄÒªÁìÖ®Ò»¡£ÔÚÕâЩÆÊÎö²âÊÔÖУ¬Ã¸ÀàÒ©ÎïµÄ±ê³Æ(Íâ¼Ó)Ũ¶Èͨ³£ÊÇng/mL»ò?g/mL£»È»¶ø£¬¼Ó±êQCÑùÆ·²â¶¨ÖµµÄ»îÐÔµ¥Î»Îªnmol/h/mL»ònmol/h/?g¡£ÕâЩQCµ¥Î»ÉϵIJî±ð×é³ÉÁËÆæÌصÄÌôÕ½£¬ÒòΪËü²»¿ÉÅÌËã׼ȷ¶È¡£ÔÚÕâÖÖÇé¿öÏ£¬¿ÉÒÔͨ¹ý½¨Á¢QCµÄ±ê³Æ»îÐÔÖµ£¨nominal activity value£©À´¿Ë·þÕâ¸ö¾ÖÏÞÐÔ¡£Ã¿¸öŨ¶È¼¶±ðµÄ±ê³ÆQC»îÐÔÖµ¿ÉÒÔ£¬ÓÉÖÁÉÙ2ÈË£¬Æ¾¾ÝÖÁÉÙ30´Î¼°¸ñÔËÐÐµÄÆ½¾ù²â¶¨»îÐÔÖµ£¬ÔÚÖÁÉÙ10-20ÌìÄÚ½¨Á¢¡£Ã¿´ÎÔËÐÐÖÁÉÙÓ¦°üÀ¨3×éQCÑùÆ·¡£ËùÓм°¸ñÔËÐÐµÄÆ½¾ù»îÐԲⶨֵ£¬¼´ÎªQCµÄ±ê³Æ»îÐÔÖµ£¬²¢¿ÉÒÔʹÓÃÏÂÃæµÄ¹«Ê½ÅÌËãµ¥¸öQCÑùÆ·µÄ%RE£ºÆäÖУ¬±ê³ÆQC»îÐÔÖµm30£¬¼ÄÒåÊǽøÐÐ30´ÎÔËÐÐËù²â¶¨»îÐÔµÄÆ½¾ùÖµ¡£ÔÚ×î³õµÄ²âÊÔÍê³ÉÖ®ºó£¬ÈÕ³£ÔËÐкÍÌæ»»QCÅú´ÎµÄ½ÓÊܱê×¼¾ÍÊÇQC»îÐÔ±ê³ÆÖµµÄ±20%¡£±í2×ܽáÁËÉÏÃæÌÖÂ۵ģ¬ÓйØÌØÊâÀà±ðµÄQCÑùÆ·µÄ×¢ÒâÊÂÏî¡£±í2. ¶ÔÌØÊâÀà±ðQCÑùÆ·µÄÒªÇóµÄ×ܽáÌØ±ðÉùÃ÷±¾ÎÄÈçÓÐÊ詺ÍÎó¶ÁÏà¹ØÖ¸ÄϺÍÊý¾ÝµÄµØ·½£¬Çë¶ÁÕ߯ÀÂÛºÍÖ¸Õý¡£ËùÓÐÒýÓõÄÔʼÐÅÏ¢ºÍ×ÊÁϾùÀ´×ÔÒѾÐû²¼Ñ§ÊõÆÚ¿¯, ¹Ù·½ÍøÂ籨µÀ, µÈ¹ûÕæÇþµÀ, ²»Éæ¼°Èκα£ÃÜÐÅÏ¢¡£²Î¿¼ÎÄÏ×µÄÑ¡Ôñ¿¼Âǵ½¶àÑù»¯µ«Ò²²»¿ÉÄÜÍ걸¡£½Ó´ý¶ÁÕßÌṩÓмÛÖµµÄÎÄÏ×¼°ÆäÆÀ¹À¡£À©Õ¹ÔĶÁ²Î ¿¼ ÎÄ Ï×1. Azadeh, M., et al., Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift. The AAPS journal, 2019. 21(5): p. 89.2. DeSilva B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. AAPS J. 2003;20(11):1885¨C900.3. Viswanathan CT, et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm. Res. 2007;24(10):1962¨C73.4. US Food and Drug Administration. Guidance for industry: bioanalytical method validation. Silver Spring: Center for Drug Evaluation and Research; 2018.5. Azadeh M, et al. Calibration curves in quantitative ligand binding assays: recommendations and best practices for preparation, design, and editing of calibration curves. AAPS J. 2018;20:22.6. Nowatzke W, Woolf E. Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples. AAPS J. 2007;9(2):F117¨CE122.7. Marcelletti JF, et al. Calculations for adjusting endogenous biomarker levels during analytical recovery assessments for ligand-biding assay bioanalytical method validation. AAPS J. 2015;17(4):939¨C47.8. US Food and Drug Administration. Guidance for industry: assay development and validation for immunogenicity testing of therapeutic protein products. Silver Spring: Center for Drug Evaluation and Research; 2019.9. U.S. Department of Health and Human Services Food and Drug Administration, Process validation: general principles and practices. Guidance for industries; 2011.10. Sondag P, et al. In: Zhang L, editor. Nonclinical statistics for pharmaceutical and biotechnology industries. Statistics for Biology and Health. Cham: Springer; 2016.p.415¨C32.11. Schofield T. Lifecycle approach to bioassay. In: Nonclinical statistics for pharmaceutical and biotechnology industries. Cham: Springer; 2016. p.433¨C60.12. Scherder T, et al. Continued process verification. In: Statistics for biotechnology process development. Boca Raton: Chapman and Hall/CRC; 2018. p. 265¨C84.13. Levey S, et al. The use of control charts in the clinical laboratory. Am J Clin Pathol. 1950;20(11):1059¨C66.14. Montgomery DC. Introduction to statistical quality control. 6th ed. Hoboken: Arizona State University, Wiley; 2009.15. Westgard JO. Interpreting SQC results using ¡°Westgard Rules¡±. In: Westgard JO, editor. Basic QC practices, vol. 2016. 4th ed. Madison: Westgard QC; 1998. p. 45¨C58.16. Sullivan LP. Reducing variability: a replacement approach to quality. Qual Prog. 1984.17. Kelly M, et al. Large molecule run acceptance: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team. AAPS J. 2014;16(2):221¨C5.18. Parvin CA, et al. C24-A4. Statistical quality control for quantitative measurement procedures: principles and definitions. 4th ed. Wayne: Clinical and Laboratory Standards Institute; 2016.19. Westgard JO. Statistical quality control procedures. Clin Lab Med. 2013;33(1):111¨C24.20. Geist B, et al. Monitoring quality of critical reagents used in ligand binding assays with liquid chromatography mass spectrometry. In: Protein analysis using mass spectrometry. Hoboken: Wiley; 2017. p. 107¨C23.
2021-05-315ÔÂ24-26ÈÕ£¬»¯Ñ§¼ÓÍø2021ÖйúÒ½Ò©CMC¹¤ÒµÁ´ÆóÒµ¼Ò¿ÆÑ§¼Òá¯ÁëÂÛ̳ÔÚ¹ãÖÝÂ¡ÖØ¾ÙÐС£Öйú¿ÆÑ§Ôº³Â¿ÏÈԺʿ¡¢Âí´óΪԺʿ¡¢Öйú¹¤³ÌÔº³Â·Ò¶ùԺʿ¡¢ôßÄÏ´óѧҩѧԺԺ³¤¶¡¿Ë¡¢ÄÏ·½¿Æ¼¼´óѧ»¯Ñ§ÏµÏµÖ÷ÈÎÕÅÐ÷Ä¡¢»ª¶«Ê¦·¶´óѧ½ÌÊÚ½ªÑ©·å½ÌÊÚµÈÊý°ÙÃûÀ´×ÔÒ½Ò©ÁìÓò¡¢ÆóÒµ½ç¡¢Ñ§½ì´ó¿§Æë¾ÛÒ»Ì㬷ÖÏíÑо¿½á¹û£¬Í¬Ä±¹¤ÒµÎ´À´¡£ÍþÁ®Ï£¶ûwilliamhillÒ½Ò©¶Ê³¤ÍõÍ¢´º¡¢¸±×ܾÀíÂíÈÊÇ¿¡¢×Ó¹«Ë¾ÃÀ¹úºº·ðÀ³Ê×ϯÔËÓª¹ÙÕÔ¶«ÊÜÑû³öϯ±¾´Î¼¯»á²¢·¢Ñݳö½²¼°¼ÓÈëÔ²×ÀÌÖÂÛ¡£ÔÚ5ÔÂ24Èյķֻ᳡ËÄÖУ¬ÂíÈÊÇ¿Ðû²¼ÁËÃûΪ¡¶·ÇÁÙ´²ÆÀ¼ÛÔÚÐÂÒ©ÉóÆÀÓëͶ×ÊÖеÄÓ¦Óá·Ñݽ²£¬Í¬Óë»áÕß·ÖÏíÁ˶¯ÎïʵÑé¡¢Ò©Àí¶¾ÀíÑо¿µÈ·ÇÁÙ´²ÆÀ¼ÛÒµÎñÔÚÐÂÒ©×¢²áºÍͶ×ÊÆÀ¹ÀÖеÄ×÷ÓúͼÛÖµ¡£5ÔÂ25ÈÕ£¬ÕÔ¶«ÔòÒÔ¡¶ÖÐÃÀË«±¨ÖÐµÄ CMC ¿¼Á¿¡·ÎªÌ⣬Ôڷֻ᳡ÏòÓë»áÕßÖØµã̸¼°ÁËÔÙÉúҽѧÔÚÖÐÃÀË«±¨CMCÖеÄÖØÒª×÷Óá£5ÔÂ26ÈÕ£¬ÍõÍ¢´º³öϯ´ó»áÖ÷»á³¡²¢¼ÓÈëÔ²×ÀÌÖÂÛ»·½Ú£¬Í¬Óë»á¼Î±öÅäºÏÎ§ÈÆÈçºÎѰÕÒ»¯Ñ§Á¢ÒìÓëÒ©Î﹤ҵ»¯Éý¼¶Ö®¼äµÄÇÅ£¬ÉúÃü¿ÆÑ§Ô´´ÐÔÑо¿ÓëÉúÎïÒ½Ò©ÈçºÎ²úѧÑнáºÏ£¬ÅÓ´óÖÆ¼ÁµÄ·ÂÖÆÒ©¿ª·¢ÒÔ¼°ÄÉÃ×ÖÆ¼ÁµÄ¿ª·¢£¬ÖйúÈËÌ幤³Ìѧ¡¢ÖƼÁѧÓëÐËÍú¹ú¼ÒµÄ²î±ð£¬´óѧҩѧԺÓëÆóÒµÒ©ÎïÑо¿ÔºÈçºÎÁ¢Òì¹²Ïí¡¢ÏàÖúÉú³¤µÈ»°ÌâÕ¹¿ªÌÖÂÛ£¬Óë»á¼Î±öÖ±ÊãÐØÒÜ£¬·ºÂÛ¼º¼û£¬ÒýµÃ³¡ÏÂÕÆÉùÕóÕó¡£
2021-05-27×òÈÕ£¨5ÔÂ20ÈÕ£©£¬DIA 2021ÖйúÄê»áÔÚËÕÖݹú¼Ê²©ÀÀÖÐÐÄÂ¡ÖØ¾ÙÐС£ÍþÁ®Ï£¶ûwilliamhillҽҩЯ×Ó¹«Ë¾ÃÀ¹úºº·ðÀ³¡¢ÉϺ£íÀÂë˹¡¢ËÕÖÝÐñ»Ô¼ì²â¾«²ÊÁÁÏà´Ë´ÎÊ¢»á¡£¾Ý½éÉÜ£¬±¾´ÎDIA 2021ÖйúÄê»á½«Á¢×ãÓÚÐÂÒ©Ñз¢¹ú¼Ê»¯ºÍº£ÄÚÁ¢ÒìµÄË«ÖØÇ÷ÊÆ£¬ÄÚÈÝÈ«Ãæ¾Û½¹¼à¹ÜÕþ²ßÁ¢Òì¡¢¿ÆÑ§¼¼ÊõÁ¢ÒìÒÔ¼°È˲ÅÁ¢ÒìÈý´óÆ«Ïò£¬Ð¯ÊÖÒ©ÑÐÁìÓòÖÚ¶àͬÈÊÃǽ𼦺þÅÏÔÙ³ö·¢£¬12ÄêÀú³ÌÔÙ¿´Ò©ÎïÑз¢È«Çò»¯µÄ´«³ÐÓëÁ¢Òì¡£×÷Ϊº£ÄÚÖªÃûCROÉÏÊÐÆóÒµ£¬ÍþÁ®Ï£¶ûwilliamhillÒ½Ò©Óë×Ó¹«Ë¾ÃÀ¹úºº·ðÀ³¡¢ÉϺ£íÀÂë˹¡¢ËÕÖÝÐñ»Ô¼ì²âµÄÁªºÏչλÔÚÏÖ³¡ÆÄΪÁÁÑÛ¡£ÍþÁ®Ï£¶ûwilliamhillÒ½Ò©Éî¸ûCROÁìÓò½ü20Ä꣬ÖÂÁ¦ÓÚÌṩÁ¢ÒìÒ©ÁÙ´²Ñо¿¡¢Ò©Ñ§Ñо¿¡¢Ò©ÎïÆÀ¼Û¡¢ÖÐÃÀË«±¨¡¢CDMOÉú²úµÄһվʽȫÁ÷³ÌÑз¢Íâ°üЧÀÍ¡£ÍþÁ®Ï£¶ûwilliamhillÒ½Ò©Ïà¹ØÂôÁ¦ÈËÌåÏÖ£¬ÍþÁ®Ï£¶ûwilliamhillÒ½Ò©Óë×Ó¹«Ë¾ÃÀ¹úºº·ðÀ³¡¢ÉϺ£íÀÂë˹¡¢ËÕÖÝÐñ»Ô¼ì²âÁªºÏ²ÎÕ¹£¬³ä·ÖÏòÒµ½çչʾÁË×ÔÉíÔÚCROÍâ°üЧÀÍÓëÖÐÃÀË«±¨·½ÃæµÄ½¹µãʵÁ¦£¬Áî¿ÍÉ̽øÒ»²½Á˽âÁËÍþÁ®Ï£¶ûwilliamhillÒ½Ò©ÔÚCROÁìÓòµÄ½¹µã¾ºÕùÁ¦£¬ÎªºóÐøµÄ½»Á÷ÏàÖúµÓÚ¨ÁËÁ¼ºÃµÄ»ù´¡¡£
2021-05-21ÔÁ¹«Íø°²±¸ 44011202001884ºÅ
ÔÁ¹«Íø°²±¸ 44011202001884ºÅ