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Concordance analysis between Human Papillomavirus genotyping assay and PCR-reverse spot hybridization for the detection of Human Papillomavirus infection
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Yanlin Chen1,2, Ye Li1,2, Lifang Xue1,2, Mu Xu1,2, Liying Wang1,2, Binhua Dong1,2,3,4
and Liangzhi Cai1,2
Abstract
Introduction. Human papillomavirus (HPV), the predominant viral infection affecting the anogenital tract, is closely linked to the development of intraepithelial neoplasia and malignancies in the cervix and other anal regions. Currently, 15 high-risk HPVs (HR-HPVs) and 3 potential HR-HPV types have been recognized as contributors to cervical cancer. Consequently, it is imperative to conduct HR-HPV screening using suitable tests in order to identify precancerous lesions and prevent the development of cancer.
Hypothesis. The Human papillomavirus genotyping (type 23) detection kit (PCR-reverse point hybridization method) is reliable for clinical testing.
Aims. The objective of this research was to assess the concordance between the Human papillomavirus genotyping (type 23) detection kit (PCR-reverse point hybridization method) and the approved HPV test.
Methodology. A sample of 781 women who received HPV genotype testing during cervical cancer screening consultations at the Department of Gynecology, Fujian Maternity and Child Health Hospital, was examined. Thirty-two cases were excluded for lacking histological results or showing signs of vulvar intraepithelial rheology, leaving 749 valid histological samples. Only 181 valid pathological specimens were available after excluding those without cervical biopsy or total hysterectomy. The consistency of the test results was assessed using the kappa (K) statistic, with CIN2+ serving as the benchmark for determining sensitivity and specificity. Statistical significance was defined as differences with P values <0.05 (two-tailed).
Results. The human papillomavirus genotyping (type 23) detection kit (PCR-reverse point hybridization method) and the approved HPV test demonstrated a high level of concordance with a total kappa value of 0.969 (P<0.05). The overall concordance rate was found to be 98.720%. Using cervical intraepithelial neoplasia grade 2+ (CIN2+) as the reference standard, the human papillomavirus genotyping (type 23) detection kit (PCR-reverse point hybridization method) and the approved HPV test both showed 89.655% sensitivity (P>0.05), while the specificity values were 40.590 and 40.309%, respectively (P>0.05).
Conclusion. The evaluated HPV test demonstrates comparable performance to other assays available during the same time frame and exhibits strong concordance in detecting the majority of HPV genotypes.
- Received:
- Accepted:
- Published Online:
Funding
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Fujian Provincial Health Technology Project
(Award 2020Y9402)
- Principal Award Recipient: LiangzhiCai
© 2024 The Authors