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申请/专利权人：江苏鹍远生物科技股份有限公司

摘要：本发明涉及用于甲状腺肿瘤良恶性鉴别和恶性潜能未定的滤泡性肿瘤评估的甲基化标志物、试剂盒、装置、计算机可读介质和系统。

主权项：1.检测样品中甲基化标志物的CpG位点甲基化的试剂在制备用于鉴定样品中甲状腺肿瘤良恶性的试剂盒中的用途，其中，所述甲基化标志物是核酸分子，所述核酸分子具有（1）人基因组的以下序列：chr1:119543868:119543879，chr1:180202465:180202541，chr1:203044677:203044823，chr1:203045227:203045293，chr10:124896784:124897154，chr12:52745149:52745173，chr13:92051635:92051674，chr14:38071275:38071410，chr14:38091345:38091744，chr14:60977845:60977865，chr16:85620063:85620331，chr17:40937184:40937480，chr17:46631705:46632377，chr18:19747115:19747127，chr18:70209347:70209475，chr2:105474371:105474381，chr2:203036052:203036236，chr2:80530770:80530826，chr2:95401381:95401629，chr21:38077572:38077685，chr4:111554966:111554989，chr4:1400384:1400459，chr4:40632502:40632519，chr5:72594262:72594269，chr6:168502296:168502347，chr7:101241802:101241926，chr7:157485865:157486031，chr7:158798629:158798674，chr7:27182264:27183525，chr7:45002063:45002754，chr7:50467662:50468309，chr8:55366694:55366747，chr9:139740669:139740676，chr1:16862044:16862199，chr10:102822370:102822647，chr10:105253375:105253477，chr12:116946248:116946304，chr12:50355085:50355570，chr12:52652220:52652362，chr13:32605660:32605843，chr13:77459521:77459792，chr14:102172655:102172687，chr16:88599725:88600068，chr17:80009015:80009025，chr19:12831808:12832195，chr19:13213485:13213513，chr19:13213644:13213814，chr19:15344092:15344411，chr19:8674674:8674749，chr20:48902548:48902611，chr22:42710260:42710349，chr3:193987426:193987681，chr3:194208192:194208617，chr6:31696240:31696334，chr7:26415826:26415917，chr11:2000109:2000154，chr15:48470425:48470556，chr15:60883371:60883395，chr16:4715122:4715220，chr19:52104749:52104928，chr2:128158537:128158621，chr21:48087183:48088183，chr22:38071168:38071189，和chr7:26415938:26416562，或（2）（1）的互补序列，各甲基化标志物或其互补序列的对应算法如下所示：chr1:119543868:119543879-mhl3、chr1:180202465:180202541-mhl3、chr1:203044677:203044823-mhl3、chr1:203045227:203045293-mhl3、chr10:124896784:124897154-mhl3、chr12:52745149:52745173-mhl3、chr13:92051635:92051674-mhl3、chr14:38071275:38071410-mhl3、chr14:38091345:38091744-mhl3、chr14:60977845:60977865-mhl3、chr16:85620063:85620331-mhl3、chr17:40937184:40937480-mhl3、chr17:46631705:46632377-mhl3、chr18:19747115:19747127-mhl3、chr18:70209347:70209475-mhl3、chr2:105474371:105474381-mhl3、chr2:203036052:203036236-mhl3、chr2:80530770:80530826-mhl3、chr2:95401381:95401629-mhl3、chr21:38077572:38077685-mhl3、chr4:111554966:111554989-mhl3、chr4:1400384:1400459-mhl3、chr4:40632502:40632519-mhl3、chr5:72594262:72594269-mhl3、chr6:168502296:168502347-mhl3、chr7:101241802:101241926-mhl3、chr7:157485865:157486031-mhl3、chr7:158798629:158798674-mhl3、chr7:27182264:27183525-mhl3、chr7:45002063:45002754-mhl3、chr7:50467662:50468309-mhl3、chr8:55366694:55366747-mhl3、chr9:139740669:139740676-mhl3、chr1:203044677:203044823-mhl、chr13:92051635:92051674-mhl、chr14:60977845:60977865-mhl、chr18:19747115:19747127-mhl、chr7:27182264:27183525-mhl、chr1:16862044:16862199-pdr、chr10:102822370:102822647-pdr、chr10:105253375:105253477-pdr、chr12:116946248:116946304-pdr、chr12:50355085:50355570-pdr、chr12:52652220:52652362-pdr、chr13:32605660:32605843-pdr、chr13:77459521:77459792-pdr、chr14:102172655:102172687-pdr、chr16:88599725:88600068-pdr、chr17:80009015:80009025-pdr、chr19:12831808:12832195-pdr、chr19:13213485:13213513-pdr、chr19:13213644:13213814-pdr、chr19:15344092:15344411-pdr、chr19:8674674:8674749-pdr、chr20:48902548:48902611-pdr、chr22:42710260:42710349-pdr、chr3:193987426:193987681-pdr、chr3:194208192:194208617-pdr、chr6:31696240:31696334-pdr、chr7:26415826:26415917-pdr、chr10:102822370:102822647-umhl、chr11:2000109:2000154-umhl、chr15:48470425:48470556-umhl、chr15:60883371:60883395-umhl、chr16:4715122:4715220-umhl、chr19:52104749:52104928-umhl、chr2:128158537:128158621-umhl、chr21:48087183:48088183-umhl、chr22:38071168:38071189-umhl、chr7:26415938:26416562-umhl，所述试剂是选自以下甲基化检测方法的一个或多个中所用的试剂：基于重亚硫酸盐转化的PCR、DNA测序、甲基化敏感的限制性内切酶分析法、荧光定量法、甲基化敏感性高分辨率熔解曲线法、基于芯片的甲基化图谱分析、质谱，所述核酸分子的序列编号参考hg19，所述鉴定样品中甲状腺肿瘤良恶性包括步骤：（1）获取样品中所述甲基化标志物的CpG位点的甲基化水平，（2）使用所述算法处理所述甲基化水平，（3）利用步骤（2）的经处理的甲基化水平获得评分，和（4）鉴定样品中甲状腺肿瘤良恶性。

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