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J Virol Methods. 2015 Nov;224:35-41. doi: 10.1016/j.jviromet.2015.08.008. Epub 2015 Aug 20.

Performance of the HPV-16 L1 methylation assay and HPV E6/E7 mRNA test for the detection of squamous intraepithelial lesions in cervical cytological samples.

Author information

1
Department of Cytopathology, The Third Affiliated Hospital of Zhengzhou University, No. 7 Front Kangfu Street, Er'qi District, Zhengzhou 450052, China.
2
The Cancer Hospital Affiliated to Zhengzhou University, No. 127 Dongming Street, Jinshui District, Zhengzhou 450008, China.
3
The Second Affiliated Hospital of Zhengzhou University, No. 2 Jingba Street, Guancheng Hui District, Zhengzhou 450014, China.
4
University of Florida Shands Cancer Center, Gainesville, FL, USA.
5
Engineering Research Center of Microbial Tumer Marker and Drug Sensitive Test, Xinxiang, Henan, 453400, China.
6
Department of Cytopathology, The Third Affiliated Hospital of Zhengzhou University, No. 7 Front Kangfu Street, Er'qi District, Zhengzhou 450052, China. Electronic address: sqh1213@outlook.com.

Abstract

HPV-16 L1 methylation and E6/E7 mRNA have suggested that they had close relationship with cervical neoplastic progression. This study aimed to evaluate the clinical performance of the HPV-16 L1 methylation assay and E6/E7 mRNA test for detecting high-grade cervical lesions (CIN2+). A total of 81 women with liquid-based cytology (LBC) samples, histological results, and positive HPV-DNA test for HPV type 16 only were included in this study. HPV-16 L1 methylation and E6/E7 mRNA levels were measured using methylation-sensitive high resolution melting (MS-HRM) analysis and Quantivirus®HPV E6/E7 RNA 3.0 assay (bDNA), respectively, in the same residue of LBC samples. The current date showed a positive correlation between the HPV-16 L1 methylation and the E6/E7 mRNA levels. The L1 methylation and mRNA levels both increased with disease severity. The mRNA test method showed higher sensitivity and NPV (98.0 and 91.7% vs. 89.8 and 80.8%), while lower specificity and PPV (34.4 and 69.6% vs. 65.6 and 80.0%), than the L1 methylation assay for detecting histology-confirmed CIN2+. When using the detection method of mRNA test combined with L1 methylation assay, we obtained a sensitivity of 89.8% and a specificity of 71.9%. These findings suggest that assessment of HPV-16 L1 methylation testing combined with E6/E7 mRNA testing may be a promising method for the triage of women with HPV type 16 only.

KEYWORDS:

Cervical lesion; DNA methylation; E6/E7 mRNA; Human papillomavirus

PMID:
26297960
DOI:
10.1016/j.jviromet.2015.08.008
[Indexed for MEDLINE]

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