CINtec PLUS: A Novel Alternative Screening Method for Detecting High-Risk Cervical Lesions in Romania

Introduction CINtec PLUS is a relatively recent method introduced in Romania for detecting cervical precancerous lesions. This technique utilizes simultaneous double immunostaining with p16 and Ki67 to identify potentially transformative human papillomaviruses (HPVs). CINtec PLUS has demonstrated superior sensitivity and specificity compared to conventional Papanicolaou (PAP) cytology and PAP liquid-based cytology, allowing for more accurate identification of HPV infections that may progress to malignancy among women with abnormal screening results. The objectives of this study are to evaluate CINtec PLUS test results in comparison with PAP cytology and HPV genotype detection among Romanian women and to assess its potential as a complementary screening method within existing national cervical cancer screening programs. Materials and methods Cases were collected between December 22, 2022, and June 15, 2024. All 96 women enrolled in the study, regardless of the presence of pathological cervical lesions, underwent the CINtec PLUS test. The samples were stained using the Roche CINtec PLUS kit. Statistical analyses were performed using IBM SPSS Statistics for Windows, Version 26.0 (Released 2019; IBM Corp., Armonk, NY, USA). To assess correlations and compare variables, we utilized crosstabulation tables, frequency tables, the chi-square test, and the Pearson correlation coefficient. Results The age range of participants in our study was from 19 to 64 years, with a mean age of 35.77 years and a standard deviation of 9.608. Among the women who underwent the CINtec PLUS test, over two-thirds were aged between 20 and 39 years. In 7.3% of cases with no history of HPV infection or cervical cytologic lesions, the CINtec PLUS test yielded a positive result. The study also revealed that CINtec PLUS showed a positive result in 23.3% of cases diagnosed with atypical squamous cells of undetermined significance on PAP cytology. Additionally, 36.5% of women who underwent CINtec PLUS testing as a screening method had a positive result, with more than one-fifth of these cases being positive. Conclusions The CINtec PLUS test is a valuable tool for identifying high-risk cervical lesions. Despite the limitations of our study, it provides a foundation for further research into the long-term benefits and cost-effectiveness of this test. Future studies could explore its potential for integration into national screening programs.