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Hildesheim A, Herrero R, Bratti M C, Sherman ME Evaluationof Isothermal Amplification Technology for HPV Detection in Cervical Cancer Screening WANG Lin, JIANG Mingyue, CAO Xuefang,, LI Li, QIN Yu2 wU Zeni", LI Tingyuan", WU Ting, CHEN Wen (l. State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of diagnostics and vaccine Development in In fectious Diseases, School of Public Health, Xiamen University, Xiamen, Fujian 361102, China 2. Department of Cancer Epidemiology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China: 3. School of Public Health, Xijiang University, Urumchi 830011, China) Abstract: To evaluate the feasibility and utility of isothermal DNA amplification test(Isomega)in highrisk human papillomavirus(HR-HPV)detection and cervical cancer screening. From June to August in 2016 2, 774 women aged from 30 to 64 years old with sexual activity history were recruited in Inner mongolia China for cervical cancer screening. Liquid-based cytology, Isomega and Hybrid Capture 2(HC2) technol- ogies were applied for all samples. INNO-LiPA HPV Genotyping Extra was used as a reference to evaluate inconsistent results by the two methods, and either HPV16 or HPV18 positive. The sensitivity and speci ficity of Isomega and HC2 were for detection of cervical intraepithelial neoplasia grade 2( CIN2) and CIN2+ were also calculated. The total concordance rate for Isomega and HC2 was 92. 72%( Kappa=0.74),in which the positive concordance rate was 86.78%, and the negative concordance rate was 93.77%. On the basis of INNO-LiPa genotyping detection, the accuracy rate of HPV16 and HPV18 was 94. 74% and 83.87%, respectively, for Isomega. The sensitivity and specificity were 87. 76% and 82 94% for Isomega respectively. These data suggest that Isomega HPV test can detect HPV16 and HPv18 and other highrisk HPV accurately, and yield fairly good sensitivity and specificity for cervical cancer screening Key words: Cervical cancer: Human papillomavirus (HPV); Screening; Isothermal amplification Corres ponding author CHEN Wen, Enail: chenwenacicams accn 21994-2018ChinaAcademicJOurnalElectronicpUblishingHouse.Allrightsreservedhttp:/www.cnki.netｔｅｓｔｉｎｔｈｅｃｅｒｖｉｃａｌｃａｎｃｅｒｓｃｒｅｅｎｉｎｇ：ｒｅｐｒｏｄｕｃｉｂｉｌｉｔｙａｓ－ ｓｅｓｓｍｅｎｔａｎｄｉｎｖｅｓｔｉｇａｔｉｏｎｏｎｃｙｔｏｌｏｇｉｃａｌｏｕｔｃｏｍｅｏｆ ＨｙｂｒｉｄＣａｐｔｕｒｅ２ ｂｏｒｄｅｒｌｉｎｅｓａｍｐｌｅｓ［Ｊ］．Ｅｐｉｄｅｍｉｏｌ Ｐｒｅｖ，２０１６，４０（３－４）：１６４－１７０． ［１４］ＰｒｅｉｓｌｅｒＳ，ＲｅｂｏｌｊＭ，ＥｊｅｇｏｄＤ Ｍ，ＬｙｎｇｅＥ，Ｒｙｇａａｒｄ Ｃ，ＢｏｎｄｅＪ．Ｃｒｏｓｓ－ｒｅａｃｔｉｖｉｔｙｐｒｏｆｉｌｅｓｏｆｈｙｂｒｉｄｃａｐｔｕｒｅ ＩＩ，ｃｏｂａｓ，ａｎｄＡＰＴＩＭＡｈｕｍａｎｐａｐｉｌｌｏｍａｖｉｒｕｓａｓｓａｙｓ： ｓｐｌｉｔ－ｓａｍｐｌｅｓｔｕｄｙ［Ｊ］．ＢＭＣＣａｎｃｅｒ，２０１６，１６：５１０． ［１５］ＣａｓｔｌｅＰＥ，Ｓｃｈｉｆｆｍａｎ Ｍ，ＢｕｒｋＲ Ｄ，ＷａｃｈｏｌｄｅｒＳ， Ｈｉｌｄｅｓｈｅｉｍ Ａ，ＨｅｒｒｅｒｏＲ，ＢｒａｔｔｉＭＣ，ＳｈｅｒｍａｎＭＥ， ＬｏｒｉｎｃｚＡ．Ｒｅｓｔｒｉｃｔｅｄｃｒｏｓｓ－ｒｅａｃｔｉｖｉｔｙｏｆｈｙｂｒｉｄｃａｐｔｕｒｅ ２ｗｉｔｈｎｏｎｏｎｃｏｇｅｎｉｃｈｕｍａｎｐａｐｉｌｌｏｍａｖｉｒｕｓｔｙｐｅｓ［Ｊ］． ＣａｎｃｅｒＥｐｉｄｅｍｉｏｌＢｉｏｍａｒｋｅｒｓ Ｐｒｅｖ，２００２，１１（１１）： １３９４－１３９９． ［１６］ＦｏｒｎａｒｉＤ，ＲｅｂｏｌｊＭ，ＢｊｅｒｒｅｇｒｄＢ，ＬｉｄａｎｇＭ，Ｃｈｒｉｓ－ ｔｅｎｓｅｎＩ，ＨｇｄａｌｌＥ，ＢｏｎｄｅＪ．ＨｙｂｒｉｄＣａｐｔｕｒｅ２ａｎｄ ｃｏｂａｓｈｕｍａｎｐａｐｉｌｌｏｍａｖｉｒｕｓａｓｓａｙｓｐｅｒｆｏｒｍ ｓｉｍｉｌａｒｌｙ ｏｎＳｕｒｅＰａｔｈｓａｍｐｌｅｓｆｒｏｍ ｗｏｍｅｎ ｗｉｔｈａｂｎｏｒｍａｌｉｔｉｅｓ ［Ｊ］．Ｃｙｔｏｐａｔｈｏｌｏｇｙ，２０１６，２７（４）：２４９－２６０． ＥｖａｌｕａｔｉｏｎｏｆＩｓｏｔｈｅｒｍａｌＡｍｐｌｉｆｉｃａｔｉｏｎＴｅｃｈｎｏｌｏｇｙｆｏｒＨＰＶＤｅｔｅｃｔｉｏｎｉｎ ＣｅｒｖｉｃａｌＣａｎｃｅｒＳｃｒｅｅｎｉｎｇ ＷＡＮＧＬｉｎ１，ＪＩＡＮＧ Ｍｉｎｇｙｕｅ２，ＣＡＯＸｕｅｆａｎｇ２，ＬＩＬｉ３，ＱＩＮ Ｙｕ２， ＷＵＺｅｎｉ２，ＬＩＴｉｎｇｙｕａｎ２，ＷＵ Ｔｉｎｇ１，ＣＨＥＮ Ｗｅｎ２＊ （１．ＳｔａｔｅＫｅｙＬａｂｏｒａｔｏｒｙｏｆＭｏｌｅｃｕｌａｒＶａｃｃｉｎｏｌｏｇｙａｎｄＭｏｌｅｃｕｌａｒＤｉａｇｎｏｓｔｉｃｓ，ＮａｔｉｏｎａｌＩｎｓｔｉｔｕｔｅｏｆＤｉａｇｎｏｓｔｉｃｓ ａｎｄＶａｃｃｉｎｅＤｅｖｅｌｏｐｍｅｎｔｉｎＩｎｆｅｃｔｉｏｕｓＤｉｓｅａｓｅｓ，ＳｃｈｏｏｌｏｆＰｕｂｌｉｃＨｅａｌｔｈ，ＸｉａｍｅｎＵｎｉｖｅｒｓｉｔｙ，Ｘｉａｍｅｎ，Ｆｕｊｉａｎ３６１１０２，Ｃｈｉｎａ； ２．ＤｅｐａｒｔｍｅｎｔｏｆＣａｎｃｅｒＥｐｉｄｅｍｉｏｌｏｇｙ，ＮａｔｉｏｎａｌＣａｎｃｅｒＣｅｎｔｅｒ／ＣａｎｃｅｒＨｏｓｐｉｔａｌ，ＣｈｉｎｅｓｅＡｃａｄｅｍｙ ｏｆＭｅｄｉｃａｌＳｃｉｅｎｃｅｓａｎｄＰｅｋｉｎｇＵｎｉｏｎＭｅｄｉｃａｌＣｏｌｌｅｇｅ，Ｂｅｉｊｉｎｇ１０００２１，Ｃｈｉｎａ； ３．ＳｃｈｏｏｌｏｆＰｕｂｌｉｃＨｅａｌｔｈ，ＸｉｊｉａｎｇＵｎｉｖｅｒｓｉｔｙ，Ｕｒｕｍｃｈｉ８３００１１，Ｃｈｉｎａ） Ａｂｓｔｒａｃｔ：ＴｏｅｖａｌｕａｔｅｔｈｅｆｅａｓｉｂｉｌｉｔｙａｎｄｕｔｉｌｉｔｙｏｆｉｓｏｔｈｅｒｍａｌＤＮＡａｍｐｌｉｆｉｃａｔｉｏｎｔｅｓｔ（Ｉｓｏｍｅｇａ）ｉｎｈｉｇｈ－ｒｉｓｋ ｈｕｍａｎｐａｐｉｌｌｏｍａｖｉｒｕｓ（ＨＲ－ＨＰＶ）ｄｅｔｅｃｔｉｏｎａｎｄｃｅｒｖｉｃａｌｃａｎｃｅｒｓｃｒｅｅｎｉｎｇ．ＦｒｏｍＪｕｎｅｔｏＡｕｇｕｓｔｉｎ２０１６， ２，７７４ｗｏｍｅｎａｇｅｄｆｒｏｍ３０ｔｏ６４ｙｅａｒｓｏｌｄｗｉｔｈｓｅｘｕａｌａｃｔｉｖｉｔｙｈｉｓｔｏｒｙｗｅｒｅｒｅｃｒｕｉｔｅｄｉｎＩｎｎｅｒＭｏｎｇｏｌｉａ， Ｃｈｉｎａｆｏｒｃｅｒｖｉｃａｌｃａｎｃｅｒｓｃｒｅｅｎｉｎｇ．Ｌｉｑｕｉｄ－ｂａｓｅｄｃｙｔｏｌｏｇｙ，ＩｓｏｍｅｇａａｎｄＨｙｂｒｉｄＣａｐｔｕｒｅ２（ＨＣ２）ｔｅｃｈｎｏｌ－ ｏｇｉｅｓｗｅｒｅａｐｐｌｉｅｄｆｏｒａｌｌｓａｍｐｌｅｓ．ＩＮＮＯ－ＬｉＰＡ ＨＰＶＧｅｎｏｔｙｐｉｎｇＥｘｔｒａｗａｓｕｓｅｄａｓａｒｅｆｅｒｅｎｃｅｔｏｅｖａｌｕａｔｅ ｉｎｃｏｎｓｉｓｔｅｎｔｒｅｓｕｌｔｓｂｙｔｈｅｔｗｏｍｅｔｈｏｄｓ，ａｎｄｅｉｔｈｅｒＨＰＶ１６ｏｒＨＰＶ１８ｐｏｓｉｔｉｖｅ．Ｔｈｅｓｅｎｓｉｔｉｖｉｔｙａｎｄｓｐｅｃｉ－ ｆｉｃｉｔｙｏｆＩｓｏｍｅｇａａｎｄＨＣ２ｗｅｒｅｆｏｒｄｅｔｅｃｔｉｏｎｏｆｃｅｒｖｉｃａｌｉｎｔｒａｅｐｉｔｈｅｌｉａｌｎｅｏｐｌａｓｉａｇｒａｄｅ２ （ＣＩＮ２）ａｎｄＣＩＮ２＋ ｗｅｒｅａｌｓｏｃａｌｃｕｌａｔｅｄ．ＴｈｅｔｏｔａｌｃｏｎｃｏｒｄａｎｃｅｒａｔｅｆｏｒＩｓｏｍｅｇａａｎｄ ＨＣ２ｗａｓ９２．７２％ （Ｋａｐｐａ＝０．７４），ｉｎ ｗｈｉｃｈｔｈｅｐｏｓｉｔｉｖｅｃｏｎｃｏｒｄａｎｃｅｒａｔｅｗａｓ８６．７８％，ａｎｄｔｈｅｎｅｇａｔｉｖｅｃｏｎｃｏｒｄａｎｃｅｒａｔｅｗａｓ９３．７７％．Ｏｎｔｈｅ ｂａｓｉｓｏｆＩＮＮＯ－ＬｉＰＡ ｇｅｎｏｔｙｐｉｎｇｄｅｔｅｃｔｉｏｎ，ｔｈｅａｃｃｕｒａｃｙｒａｔｅｏｆ ＨＰＶ１６ａｎｄ ＨＰＶ１８ ｗａｓ９４．７４％ ａｎｄ ８３．８７％，ｒｅｓｐｅｃｔｉｖｅｌｙ，ｆｏｒＩｓｏｍｅｇａ．Ｔｈｅｓｅｎｓｉｔｉｖｉｔｙａｎｄｓｐｅｃｉｆｉｃｉｔｙｗｅｒｅ８７．７６％ａｎｄ８２．９４％ｆｏｒＩｓｏｍｅｇａ ｒｅｓｐｅｃｔｉｖｅｌｙ．ＴｈｅｓｅｄａｔａｓｕｇｇｅｓｔｔｈａｔＩｓｏｍｅｇａＨＰＶｔｅｓｔｃａｎｄｅｔｅｃｔＨＰＶ１６ａｎｄＨＰＶ１８ａｎｄｏｔｈｅｒｈｉｇｈ－ｒｉｓｋ ＨＰＶａｃｃｕｒａｔｅｌｙ，ａｎｄｙｉｅｌｄｆａｉｒｌｙｇｏｏｄｓｅｎｓｉｔｉｖｉｔｙａｎｄｓｐｅｃｉｆｉｃｉｔｙｆｏｒｃｅｒｖｉｃａｌｃａｎｃｅｒｓｃｒｅｅｎｉｎｇ． Ｋｅｙｗｏｒｄｓ：Ｃｅｒｖｉｃａｌｃａｎｃｅｒ；Ｈｕｍａｎｐａｐｉｌｌｏｍａｖｉｒｕｓ（ＨＰＶ）；Ｓｃｒｅｅｎｉｎｇ；Ｉｓｏｔｈｅｒｍａｌａｍｐｌｉｆｉｃａｔｉｏｎ ＊Ｃｏｒｒｅｓｐｏｎｄｉｎｇａｕｔｈｏｒ：ＣＨＥＮ Ｗｅｎ，Ｅ－ｍａｉｌ：ｃｈｅｎｗｅｎ＠ｃｉｃａｍｓ．ａｃ．ｃｎ · ４０５ · 病 毒 学 报 ３４卷