Rohr Irena, Skof Anna Sophie, Heinrich-Rohr Michaela, Weiss Fabian, Siedentopf Jan-Peter, von Weizsäcker Katharina, Alejandre Irene Alba, Henrich Wolfgang, Sehouli Jalid, Metz Charlotte K
Department of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
HPV Research Laboratory, Department of Gynecology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburgerplatz 1, 13353, Berlin, Germany.
Arch Gynecol Obstet. 2024 Dec;310(6):3099-3110. doi: 10.1007/s00404-024-07813-7. Epub 2024 Nov 7.
Women living with HIV (WLWH) are frequently affected by cervical dysplasia caused by Human Papillomavirus (HPV) and invasive cervical cancer (CxCa). CxCa screening programs can include colposcopy, cytology, and HPV testing. These methods, however, have limitations in effectively stratifying cervical dysplasia. This study aimed to evaluate the applicability of an innovative mRNA-based multiplexed expression-quantifying assay in the detection and assessment of cervical dysplasia in WLWH.
The QuantiGene-Molecular-Profiling-Histology Assay (QG-MPH) was used to detect and quantify HPV oncogene and cellular biomarker mRNA expression. These results were included in the Risk Score (QG-MPH RS) calculations that inform about the presence and severity of dysplasia. QG-MPH RS results were compared to the highly sensitive Multiplexed Papillomavirus Genotyping (MPG) Assay and clinical results obtained by cytology, colposcopy and histology. For a standardized nomenclature of clinical results, the clinical ASSIST Score was used.
Of 241 WLWH, including 96 pregnant women, a concordance between the QG-MPH RS and the ASSIST Score was found to 36.3% (49/135) in non-pregnant WLWH and 67.1% (57/85) in pregnant WLWH. The QG-MPH method demonstrated high specificity for detecting high-risk HPV (HR-HPV) genotypes and high-grade cervical dysplasia, achieving 89.6% and 82.4%, respectively, including pregnant and non-pregnant WLWH.
The QG-MPH assay shows potential for improving the detection and management of HPV-related cervical dysplasia in WLWH, including pregnant women. Its high specificity, however, is tempered by its tendency to overestimate dysplasia severity in certain cases, indicating that further research is needed to refine its use as a reliable diagnostic tool for this high-risk population.
感染人类免疫缺陷病毒(HIV)的女性(WLWH)经常受到人乳头瘤病毒(HPV)引起的宫颈发育异常和浸润性宫颈癌(CxCa)的影响。CxCa筛查项目可包括阴道镜检查、细胞学检查和HPV检测。然而,这些方法在有效分层宫颈发育异常方面存在局限性。本研究旨在评估一种创新的基于mRNA的多重表达定量检测方法在检测和评估WLWH宫颈发育异常中的适用性。
采用QuantiGene分子谱分析-组织学检测法(QG-MPH)检测和定量HPV致癌基因和细胞生物标志物mRNA的表达。这些结果被纳入风险评分(QG-MPH RS)计算中,以了解发育异常的存在和严重程度。将QG-MPH RS结果与高灵敏度的多重乳头瘤病毒基因分型(MPG)检测结果以及通过细胞学、阴道镜检查和组织学获得的临床结果进行比较。为了对临床结果进行标准化命名,使用了临床ASSIST评分。
在241名WLWH中,包括96名孕妇,发现QG-MPH RS与ASSIST评分之间的一致性在非妊娠WLWH中为36.3%(49/135),在妊娠WLWH中为67.1%(57/85)。QG-MPH方法在检测高危HPV(HR-HPV)基因型和高级别宫颈发育异常方面显示出高特异性,分别达到89.6%和82.4%,包括妊娠和非妊娠WLWH。
QG-MPH检测法显示出改善WLWH(包括孕妇)中HPV相关宫颈发育异常检测和管理的潜力。然而,其高特异性因在某些情况下高估发育异常严重程度的倾向而受到影响,这表明需要进一步研究以完善其作为该高危人群可靠诊断工具的应用。