Head-to-head comparison of 7 high-sensitive human papillomavirus nucleic acid detection technologies with the SPF10 LiPA-25 system  

作　　者：Jian Yin Shuqian Cheng Daokuan Liu Yabin Tian Fangfang Hu Zhigao Zhang Tiancen Zhu Zheng Su Yujing Liu Sumeng Wang Yiwei Liu Siying Peng Linlin Li Sihong Xu Chuntao Zhang Youlin Qiao Wen Chen 

机构地区：[1]Department of Cancer Epidemiology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,China [2]School of Population Medicine and Public Health,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing,China [3]Division II of In Vitro Diagnostics for Infectious Diseases,National Institutes for Food and Drug Control,Beijing,China [4]National Vaccine and Serum Institute(NVSI),Beijing,China [5]The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics,National Institute of Diagnostics and Vaccine Development in Infectious Diseases,Collaborative Innovation Center of Biologic Products,School of Public Health,Xiamen University,Xiamen,China [6]Institute of Antibody Engineering,School of Laboratory Medicine and Biotechnology,Southern Medical University,Guangzhou,China [7]College of Life Sciences,Hebei University,Baoding,China

出　　处：《Journal of the National Cancer Center》2022年第3期148-154,共7页癌症科学进展（英文）

基　　金：supported by the CAMS Innovation Fund for Medical Sciences(grant number 2021-I2M-1-004);the National Natural Science Foundation of China(grant number 81973136).

摘　　要：Background:The SPF10 LiPA-25 system for human papillomavirus(HPV)detection with high analytical perfor-mance is widely used in HPV vaccine clinical trials.To develop and evaluate more valent HPV vaccines,other comparable methods with simpler operations are needed.Methods:The performance of the LiPA-25 against that of other 7 assays,including 4 systems based on reverse hybridization(Bohui-24,Yaneng-23,Tellgen-27,and Hybribio-16)and 3 real-time polymerase chain reaction(PCR)assays(Hybribio-23,Bioperfectus-21,and Sansure-26),was evaluated in selected 1726 cervical swab and 56 biopsy samples.A total of 15 HPV genotypes(HPV 6,11,16,18,31,33,35,39,45,51,52,56,58,59,and 66)were considered for comparison for each HPV type.Results:Among the swab samples,compared to LiPA-25,compatible genotypes were observed in 94.1%of samples for Hybribio-23,92.8%for Yaneng-23,92.6%for Bioperfectus-21,92.4%for Hybribio-16,91.3%for Sansure-26,89.7%for Bohui-24,and 88.0%for Tellgen-27.The highest overall agreement of the 15 HPV genotypes combined was noted for Hybribio-23(κ=0.879,McNemar’s test:P=0.136),followed closely by Hybribio-16(κ=0.877,P<0.001),Yaneng-23(κ=0.871,P<0.001),Bioperfectus-21(κ=0.848,P<0.001),Bohui-24(κ=0.847,P<0.001),Tellgen-27(κ=0.831,P<0.001),and Sansure-26(κ=0.826,P<0.001).Additionally,these systems were also highly consistent with LiPA-25 for biopsy specimens(all,κ>0.897).Conclusions:The levels of agreement for the detection of 15 HPV types between other 7 assays and LiPA-25 were all good,and Hybribio-23 was most comparable to LiPA-25.The testing operation of HPV genotyping should also be considered for vaccine and epidemiological studies.

关 键 词：Human papillomavirus VACCINE Cervical cancer Line probe assay HPV genotyping Polymerase chain reaction 

分 类 号：R73[医药卫生—肿瘤]