HU Haixu, MA Chunhui, ZHANG Lijuan, LIU Yi, LIU Tianyi. Agreement between fluorescent quantitative PCR and automatic Bio-chips method in detection of human papillomaviruses[J]. ACADEMIC JOURNAL OF CHINESE PLA MEDICAL SCHOOL, 2023, 44(8): 908-913. DOI: 10.12435/j.issn.2095-5227.2023.066
Citation: HU Haixu, MA Chunhui, ZHANG Lijuan, LIU Yi, LIU Tianyi. Agreement between fluorescent quantitative PCR and automatic Bio-chips method in detection of human papillomaviruses[J]. ACADEMIC JOURNAL OF CHINESE PLA MEDICAL SCHOOL, 2023, 44(8): 908-913. DOI: 10.12435/j.issn.2095-5227.2023.066

Agreement between fluorescent quantitative PCR and automatic Bio-chips method in detection of human papillomaviruses

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  • Corresponding author:

    LIU Yi. Email: liuyi790114@163.com

  • Received Date: September 15, 2022
  • Available Online: August 02, 2023
  •   Background  Human papillomaviruses (HPV) genotyping is an important method for cervical cancer screening, but the insufficient technician and unqualified lab is not favorable for its application.
      Objective  To evaluate the sensitivity, specificity and overall agreement of an automatic bio-chips in detecting HPV by comparing it with fluorescent quantitative polymerase chain reaction (PCR) method.
      Methods  For clinical samples that undergoing routine fluorescence quantitative PCR testing, a simple random sampling method is used for each type. Then selected samples were tested by automatic bio-chips method, and Kappa test was used to compare the detection results of the two methods for any differences. The inconsistent results were confirmed by direct sequencing to the amplicon of E6/E7 region.
      Results  Totally 124 samples were selected randomly from 4 589 samples, including 50 negative samples and 74 positive samples (99 tests counting by cases of types). If counting by samples, the two methods were completely consistent (Kappa=1.000, P<0.0001). If counting by types, the sensitivity, specificity, positive predictive value, negative predictive value and overall agreement of automatic bio-chips was 98.0%, 92.6%, 96.0%, 96.2% and 96.1%, respectively (Kappa=0.913, P<0.0001). The inconsistent results were found in 6 positive samples (1 case each for type 39 and 59, 2 cases each for type 52 and 68), which were all confirmed in duplicate test and direct sequencing. Besides, additional 18 positive cases were found by automatic bio-chips, whose HPV types were not covered by fluorescent quantitative PCR method, thus providing more information for the treatment.
      Conclusion  Automatic bio-chips shows excellent agreement with fluorescent quantitative PCR in HPV genotyping, which has good prospect to be applied in medical institutions with insufficient technician and unqualified PCR lab.
  • [1]
    Siegel R,Miller K,Fuchs HE,et al. Cancer statistics,2022[J]. CA Cancer J Clin,2022,72(1): 7-33.
    [2]
    Pimple S,Mishra G. Cancer cervix:Epidemiology and disease burden[J]. Cytojournal,2022,19: 21. doi: 10.25259/CMAS_03_02_2021
    [3]
    Bedell SL,Goldstein LS,Goldstein AR,et al. Cervical cancer screening:past,present,and future[J]. Sex Med Rev,2020,8(1): 28-37.
    [4]
    刘一荻,吴欢,陈德福,等. 女性人乳头瘤病毒感染与宫颈鳞状上皮内病变的关系[J]. 解放军医学院学报,2021,42(3): 251-255. doi: 10.3969/j.issn.2095-5227.2021.03.003
    [5]
    Simms KT,Steinberg J,Caruana M,et al. Impact of scaled up human papillomavirus vaccination and cervical screening and the potential for global elimination of cervical cancer in 181 countries,2020-99:a modelling study[J]. Lancet Oncol,2019,20(3): 394-407.
    [6]
    Chan CK, Aimagambetova G, Ukybassova T, et al. Human papillomavirus infection and cervical cancer: epidemiology, screening, and vaccination-review of current perspectives[J/OL]. https://doi.org/10.1155/2019/3257939.
    [7]
    Li KM,Li QL,Song L,et al. The distribution and prevalence of human papillomavirus in women in mainland China[J]. Cancer,2019,125(7): 1030-1037.
    [8]
    Gradíssimo A,Burk RD. Molecular tests potentially improving HPV screening and genotyping for cervical cancer prevention[J]. Expert Rev Mol Diagn,2017,17(4): 379-391.
    [9]
    Poljak M,Oštrbenk Valenčak A,Gimpelj Domjanič G,et al. Commercially available molecular tests for human papillomaviruses:a global overview[J]. Clin Microbiol Infect,2020,26(9): 1144-1150.
    [10]
    王丽,何玉,许驰. HPV分型检测在宫颈病变诊断中的价值[J]. 中国妇幼保健,2021,36(6): 1232-1234. doi: 10.19829/j.zgfybj.issn.1001-4411.2021.06.005
    [11]
    Mongia A,Pompeo G,Sani C,et al. Hybrid capture 2 and cobas® 4800:comparison of performance of two clinically validated tests for human papillomavirus primary screening of cervical cancer[J]. J Med Screen,2021,28(4): 472-479.
    [12]
    Saville M,Sultana F,Malloy MJ,et al. Clinical validation of the cobas HPV test on the cobas 6800 system for the purpose of cervical screening[J]. J Clin Microbiol,2019,57(2): e01239-e01218.
    [13]
    Zhao PS,Liu SD,Zhong ZX,et al. Prevalence and genotype distribution of human papillomavirus infection among women in northeastern Guangdong Province of China[J]. BMC Infect Dis,2018,18(1): 204.
    [14]
    Zhang LJ,Ju Y,Hu HX,et al. Preliminary establishment and validation of a loop-mediated isothermal amplification assay for convenient screening of 13 types of high-risk human papillomaviruses in cervical secretions[J]. J Virol Methods,2022,303: 114501. doi: 10.1016/j.jviromet.2022.114501
    [15]
    Wang R,Wu J,He XD,et al. A sample-In-answer-out microfluidic system for the molecular diagnostics of 24 HPV genotypes using palm-sized cartridge[J]. Micromachines,2021,12(3): 263.
    [16]
    Alcaniz Boada E,Cuschieri K,Graham C,et al. Agreement between L1 and E6/E7-based assays for detection of high-risk HPV in cervical, oropharyngeal and penile cancers[J]. J Clin Pathol,2023,76(7): 467-473.
    [17]
    邵玲俐,张田南,姚贝. 1 359例男性患者外生殖器HPV感染亚型分布及男女分型差异分析[J]. 解放军医学院学报,2022,43(1): 55-59. doi: 10.3969/j.issn.2095-5227.2022.01.012
    [18]
    Huang WB,Xu HY,Hu HB,et al. The prevalence of human papillomavirus among women in northern Guangdong Province of China[J]. Sci Rep,2022,12(1): 13353.
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