HPV E6 and E7 mRNA Test for the Detection of High-Grade Cervical Lesions
Menée en Ethiopie à partir d'échantillons cervicaux prélevés sur 355 femmes présentant des signes ou symptômes suggestifs de lésions cervicales anormales (âge moyen : 46,4 ans), cette étude évalue la performance, pour détecter des lésions cervicales de haut grade, d'un test de recherche de l'ADN du papillomavirus humain et d'un test de recherche des ARN messagers des oncoprotéines E6 et E7
Introduction : Cervical cancer (CC) is a common public health problem worldwide. Over 95% of CC cases are associated with genital infection with high-risk human papillomavirus (HR-HPV).1 CC screening and diagnosis strategies vary across countries. Although the most frequent screening method is cytological testing, there are alternative techniques. HPV E6 and E7 messenger RNA (mRNA) are promising noninvasive biomarkers in testing high-grade cervical intraepithelial neoplasia grade 2 or higher (CIN2+) that allows detection of HPV infection and estimation of change in cervical lesions.2 Therefore, we aimed to assess the diagnostic effectiveness of the E6 and E7 mRNA test for detecting CIN2+ among Ethiopian women with gynecological concerns.
Methods : This hospital-based cross-sectional study was conducted at Felege Hiwot Comprehensive Specialized Hospital in northwest Ethiopia between March 1, 2019, and October 30, 2021. The Addis Ababa University Institutional Review Board and the Ethiopian National Research Ethics Review Committee approved the study. Written informed consent was provided by participants. We followed the STROBE reporting guideline.
Using consecutive sampling techniques, cervical specimens were collected from women who presented with signs and symptoms suggestive of abnormal cervical lesions. A gynecologist collected punch biopsies for histopathologic examinations and cervical swabs for HPV DNA and E6 and E7 mRNA testing (eMethods in Supplement 1). Data were analyzed from month year to month year with Stata, version 14.1 (StataCorp LLC).
Results : Among 355 participants (mean [SD] age, 46.4 [11.4] years), the prevalence of HR-HPV was 53.0% (188). Of 335 participants with cervical histological examination, 140 (41.8%) were diagnosed with CC. CIN2+ (including CIN2, CIN3, and cancer) was detected in 164 participants (49.0%). One hundred twenty-seven participants (35.8%) tested positive for HPV-16, HPV-18, and HPV-45 using the E6 and E7 mRNA test. Positivity rate of the HPV DNA test for these 3 HPVs was 42.0% (149). The mRNA test positivity rate increased as the cervical lesion grade increased: 5.0% (2 of 40) in CIN1, 25.0% (3 of 12) in CIN2, 50.0% (6 of 12) in CIN3, and 70.1% (94 of 134) in CC (Table 1).
Sensitivity and specificity of the mRNA assay for detecting CIN2+ were 65.2% (95% CI, 57.5%-72.2%) and 90.0% (95% CI, 84.6%-93.4%), respectively. The HPV DNA test’s detection sensitivity was higher at 84.8% (95% CI, 78.4%-89.6%), but its specificity was lower at 74.1% (95% CI, 67.1%-80.1%) (Table 2). Sensitivity, specificity, positive predictive value, and negative predictive value of the mRNA test for detecting CIN2+ among HPV DNA test–positive cases were 92.7% (95% CI, 86.2%-96.2%), 47.0% (95% CI, 30.9%-63.6%), 85.6% (95% CI, 78.1%-90.8%), and 65.2% (95% CI, 44.9%-81.2%), respectively.
JAMA Network Open , 2024