Aldariz-Amaya Rodrigo, Rodríguez-Esquivel Miriam, Ruiz-Romero Alfonso, Anthor Fernanda, Mares Emmanuel, Flores-Martínez Angélica, Gómez-Villa Edgar Alejandro, Fuentes-Garcia Marco Antonio, Apresa-García Teresa, López-Romero Ricardo, Salcedo Emmanuel, Nambo-Lucio María de Jesús, Salcedo Mauricio
Unidad de Investigación en Biomedicina y Oncología Genómica, Hospital de Gineco-Pediatría 3A, OOAD CDMX Norte, Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico.
Unidad de Posgrado, Departamento de Ciencias Biológicas, UNAM, Ciudad Universitaria, Edificio A, Piso 1, Coyoacán, C.P. 04510, Mexico City, Mexico.
Obstet Gynecol Int. 2025 Apr 28;2025:9344596. doi: 10.1155/ogi/9344596. eCollection 2025.
Human papillomavirus (HPV) is a major contributor to cervical cancer (CC), with Papanicolaou (Pap) smears and HPV testing serving as primary screening tools in developed countries. The effectiveness of these methods can vary based on a country's epidemiological and socioeconomic context. This study introduces an innovative, noninvasive method employing surgical gauze worn as a feminine pad for HPV detection, with the aim of simplifying and improving screening processes. A total of 184 participants, including individuals classified as healthy, with cervical precursor lesions, or as with confirmed CC, were enrolled. All participants underwent cytological and colposcopic evaluations, with biopsies taken in cases of abnormal results. Each participant wore the device for 8 h, after which DNA was extracted from the soiled devices and analyzed via PCR for mitochondrial and HPV-DNA. Sensitivity and specificity were calculated to assess the effectiveness of HPV detection. Sensitivity and specificity values for HPV detection were obtained. Analysis of diagnostic tests was performed by OpenEpi software. The device was well-received, with high compliance among participants. PCR analysis revealed that 17.7% of healthy, 72.1% of precursor-lesion cases, and 97.1% of CC cases tested positive for HPV. The calculated sensitivity and specificity for detecting high-grade lesions (CIN2+ or CIN2/3 and CC) were 94.81% and 51.28%, respectively. For CC detection, sensitivity was 97.14% with a specificity of 54.39%. The use of this noninvasive device demonstrated a significant correlation with clinical outcomes, supporting its potential as an effective and accessible tool for HPV screening. This method offers a promising alternative to conventional screening techniques, particularly in settings where traditional methods face logistical and socioeconomic challenges.
人乳头瘤病毒（HPV）是宫颈癌（CC）的主要致病因素，在发达国家，巴氏涂片检查和HPV检测是主要的筛查工具。这些方法的有效性可能因国家的流行病学和社会经济背景而异。本研究引入了一种创新的非侵入性方法，即使用作为女性卫生垫佩戴的手术纱布进行HPV检测，目的是简化和改进筛查过程。共有184名参与者入组，包括被分类为健康、患有宫颈前驱病变或确诊为CC的个体。所有参与者都接受了细胞学和阴道镜评估，结果异常的病例进行了活检。每位参与者佩戴该设备8小时，之后从弄脏的设备中提取DNA，并通过聚合酶链反应（PCR）分析线粒体和HPV-DNA。计算敏感性和特异性以评估HPV检测的有效性。获得了HPV检测的敏感性和特异性值。使用OpenEpi软件进行诊断试验分析。该设备受到好评，参与者的依从性很高。PCR分析显示，17.7%的健康参与者、72.1%的前驱病变病例和97.1%的CC病例HPV检测呈阳性。检测高级别病变（CIN2+或CIN2/3和CC）的计算敏感性和特异性分别为94.81%和51.28%。对于CC检测，敏感性为97.14%，特异性为54.39%。使用这种非侵入性设备显示出与临床结果有显著相关性，支持其作为一种有效且可及的HPV筛查工具的潜力。这种方法为传统筛查技术提供了一种有前景的替代方案，特别是在传统方法面临后勤和社会经济挑战的环境中。
