Zhongguo quanke yixue (Jan 2022)
Clinical Evaluation of High-risk HR-HPV E6/E7 mRNA Detection during Pregnancy
Abstract
BackgroundIt is necessary to differentiate high-risk human papillomavirus (HR-HPV) infection and cervical lesions during pregnancy using an effective measure, so as to guide personalized diagnosis and treatment and to reduce unnecessary invasive examinations during pregnancy.ObjectiveTo assess the value of HR-HPV E6/E7 mRNA detection in differentiating HR-HPV infection and cervical lesions during pregnancy by comparing efficacy between it and HR-HPV DNA testing.MethodsParticipants were healthy women with singleton pregnancy (20-45-years old) selected from Department of Obstetrics and Gynecology of Capital Medical University Xuanwu Hospital during January 2016 to January 2019. All had file creation and underwent regular prenatal examination, and those with abnormal liquid-based cytology and HR-HPV DNA testing results further underwent colposcopy with biopsy taken for pathological examination (serving as a gold standard) , and performed HR-HPV E6/E7 mRNA detection in cervical exfoliated cells collected as samples. Pathologically detected CIN Ⅱand Ⅲ were defined as high-grade cervical lesions.ResultsOf the 1 058 participants, 118 had cytological abnormalities and/or HPV 16 and 18 infections, and 84 of them consented to perform colposcopy with biopsy pathological results successfully obtained. The prevalence of HR-HPV E6/E7 mRNA positivity was lower than that of HR-HPV DNA positivity in women with CINⅠ, normal cervical epithelium or cervicitis detected by pathological examination (P<0.05) . In contrast, the prevalence of HR-HPV E6/E7 mRNA positivity was similar to that of HR-HPV DNA positivity in those with CINⅡ and Ⅲ detected by pathological examination without statistical difference (P>0.05) . In predicting CINⅡ and Ⅲ, the HR-HPV DNA testing had a sensitivity of 89.7% (26/29) , a specificity of 21.8% (12/55) , a positive predictive value of 37.1% (26/69) , and a negative predictive value of 75.0% (12/29) , and the HR-HPV E6/E7 mRNA detection had a sensitivity of 65.5% (19/29) , a specificity of 54.5% (25/55) , a positive predictive value of 43.0% (19/44) , and a negative predictive value 75.0% (25/40) . McNemar's test revealed that HR-HPV E6/E7 mRNA detection had a lower sensitivity but a higher specificity than HR-HPV DNA testing in diagnosing CINⅡ and Ⅲ (P<0.05) .ConclusionHR-HPV E6/E7 mRNA detection may have an increased specificity in diagnosing CINⅡandⅢ than HR-HPV DNA testing, so it may be used in HR-HPV positive cases for differentiating HR-HPV infections and cervical lesions to avoid unnecessary invasive examinations during pregnancy.
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