title: 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.
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.
authors: Department of Cytopathology, The Third Affiliated Hospital of Zhengzhou University, No. 7 Front Kangfu Street, Er'qi District, Zhengzhou 450052, China.
authors: Cui
authors: C
authors: Qiu
authors: Department of Cytopathology, The Third Affiliated Hospital of Zhengzhou University, No. 7 Front Kangfu Street, Er'qi District, Zhengzhou 450052, China.
authors: Yanfang
authors: Y
authors: Zhi
authors: The Cancer Hospital Affiliated to Zhengzhou University, No. 127 Dongming Street, Jinshui District, Zhengzhou 450008, China.
authors: Yong
authors: Y
authors: Shen
authors: The Second Affiliated Hospital of Zhengzhou University, No. 2 Jingba Street, Guancheng Hui District, Zhengzhou 450014, China.
authors: Jiaomei
authors: J
authors: Gong
authors: Department of Cytopathology, The Third Affiliated Hospital of Zhengzhou University, No. 7 Front Kangfu Street, Er'qi District, Zhengzhou 450052, China.
authors: Ya
authors: Y
authors: Li
authors: Department of Cytopathology, The Third Affiliated Hospital of Zhengzhou University, No. 7 Front Kangfu Street, Er'qi District, Zhengzhou 450052, China.
authors: Shouhua
authors: S
authors: Rong
authors: University of Florida Shands Cancer Center, Gainesville, FL, USA.
authors: Paul
authors: P
authors: Okunieff
authors: Engineering Research Center of Microbial Tumer Marker and Drug Sensitive Test, Xinxiang, Henan, 453400, China.
authors: Lulu
authors: L
authors: Zhang
authors: 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.
authors: Xiaofu
authors: X
authors: Li
mesh_terms: D000328:Adult; D000368:Aged; D036022:Capsid Proteins / Q000235:genetics*; D019175:DNA Methylation; D005260:Female; D052162:Human papillomavirus 16 / Q000302:isolation & purification*; D006801:Humans; D008875:Middle Aged; D009856:Oncogene Proteins, Viral / Q000235:genetics*; D012333:RNA, Messenger / Q000032:analysis*; D012367:RNA, Viral / Q000032:analysis*; D012680:Sensitivity and Specificity; D065310:Squamous Intraepithelial Lesions of the Cervix / Q000175:diagnosis*; D044366:Transition Temperature; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*
chemical_list: D036022:Capsid Proteins; D009856:Oncogene Proteins, Viral; D012333:RNA, Messenger; D012367:RNA, Viral; C063317:L1 protein, Human papillomavirus type 16
keywords: Cervical lesion; DNA methylation; E6/E7 mRNA; Human papillomavirus