# Impact of HIV infection on cervical intraepithelial neoplasia detection in pregnant and non-pregnant women in Germany: a cross-sectional study

## TL;DR

This study evaluates a new mRNA-based test for detecting cervical dysplasia in HIV-positive women, including pregnant women, in Germany.

## Contribution

The study introduces and evaluates a novel mRNA-based assay for cervical dysplasia detection in HIV-positive women.

## Key findings

- The QG-MPH assay showed high specificity for detecting high-risk HPV genotypes and high-grade cervical dysplasia.
- Concordance between the QG-MPH RS and clinical scores was higher in pregnant women compared to non-pregnant women.
- The assay tends to overestimate dysplasia severity in some cases, suggesting a need for further refinement.

## Abstract

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.

The online version contains supplementary material available at 10.1007/s00404-024-07813-7.