Diagnostic validity of human papillomavirus E6/E7 mRNA test in cervical cytological samples.
Human papillomavirus (HPV) DNA tests tend to show high sensitivity, but poor specificity in detecting high-grade cervical lesions. This study aimed to explore the clinical performance of QuantiVirus(®) HPV E6/E7 mRNA in identifying ≥Grade 2 cervical intraepithelial neoplasia. Thin-prep(®) liquid based cytology test (LBC) samples were collected from October 2009 to October 2011 from women who underwent outpatient hospital-based gynecological screening. LBC samples were processed for E6/E7 mRNA detection and HPV DNA detection. Of 335 patients, 135 (40.3%) were HPV E6/E7 mRNA positive for high-risk HPV subtypes. The positivity rate of HPV E6/E7 mRNA increased with the severity of cytological and histological evaluation. An optimal cut-off value of ≥567copies/ml was determined using receiver operating characteristic (ROC) curve, and positive predictive value and negative predictive value of cut-off value (≥567copies/ml) were higher than those of E6/E7 mRNA positivity only, but not significant. QuantiVirus(®) HPV E6/E7 mRNA testing may be a valuable tool in triage for identifying ≥Grade 2 cervical intraepithelial neoplasia. A high specificity and a low positivity rate of E6/E7mRNA testing as a triage test in HPV DNA-positive women can be translated into a low referral for colposcopy. Studies composed of large population-based samples of women and with rigorous disease ascertainment, are needed to establish the optimal cut-off point based on ROC curve analysis.
Fujian Provincial Tumor Hospital, Teaching Hospital of Fujian Medical University, Fuzhou, Fujian 350014, China.
Tong-Yu
TY
Liu
Fujian Provincial Tumor Hospital, Teaching Hospital of Fujian Medical University, Fuzhou, Fujian 350014, China.
Rong
R
Xie
Chinese Center for Disease Control and Prevention, 27 Nanwei Road, Beijing 100050, China.
Li
L
Luo
Independent Consultant, New York, NY, USA.
Kathleen H
KH
Reilly
Department of Pathology, Fujian Tumor Hospital, Fuzhou, Fujian 350014, China.
Cheng
C
He
Fujian Provincial Tumor Hospital, Teaching Hospital of Fujian Medical University, Fuzhou, Fujian 350014, China.
Yu-Zhen
YZ
Lin
Department of Pathology, Fujian Tumor Hospital, Fuzhou, Fujian 350014, China.
Gang
G
Chen
Department of Pathology, Fujian Tumor Hospital, Fuzhou, Fujian 350014, China.
Xiong-Wei
XW
Zheng
Engineering Research Center of Microbial Tumor Marker and Drug Sensitive Test, Xinxiang, Henan 453400, China.
Lu-Lu
LL
Zhang
Chinese Center for Disease Control and Prevention, 27 Nanwei Road, Beijing 100050, China. Electronic address: hbwang2005@163.com.
Hai-Bo
HB
Wang
D002278:Carcinoma in Situ / Q000175:diagnosis* / Q000821:virology; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009856:Oncogene Proteins, Viral / Q000096:biosynthesis / Q000235:genetics; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis*; D011237:Predictive Value of Tests; D012333:RNA, Messenger / Q000032:analysis* / Q000235:genetics; D012367:RNA, Viral / Q000032:analysis / Q000235:genetics; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014773:Virology / Q000379:methods*
D009856:Oncogene Proteins, Viral; D012333:RNA, Messenger; D012367:RNA, Viral
Cervical intraepithelial neoplasia; HPV E6/E7 mRNA; Human papillomavirus