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CINtec PLUS: A Novel Alternative Screening Method for Detecting High-Risk Cervical Lesions in Romania
Ovidiu A Camarasan1, Andreea Camarasan2, Mihaela M Muresan2
1Department of Obstetrics and Gynecology, "Prof. Dr. Ioan Pușcaș" City Hospital of Șimleu Silvaniei, Oradea, ROU.
Cureus
|October 14, 2024
Summary
The CINtec PLUS test, using p16/Ki67, shows promise for detecting cervical precancerous lesions in Romanian women. It offers higher accuracy than traditional Pap tests, aiding in identifying high-risk human papillomaviruses (HPVs).
Area of Science:
- Gynecologic Oncology
- Molecular Diagnostics
- Cervical Cancer Screening
Background:
- Cervical precancerous lesions require accurate detection for effective management.
- Conventional Papanicolaou (PAP) cytology has limitations in sensitivity and specificity.
- Human papillomaviruses (HPVs) are the primary cause of cervical cancer.
Purpose of the Study:
- To evaluate the CINtec PLUS test's performance against PAP cytology and HPV genotyping in Romanian women.
- To assess the potential of CINtec PLUS as a complementary tool in national cervical cancer screening programs.
- To identify potentially transformative HPV infections using simultaneous p16 and Ki67 immunostaining.
Main Methods:
- Collected samples from 96 Romanian women between December 2022 and June 2024.
- Performed the CINtec PLUS test using the Roche CINtec PLUS kit.
- Analyzed data using IBM SPSS Statistics, employing crosstabulation, frequency tables, chi-square, and Pearson correlation.
Main Results:
- The CINtec PLUS test yielded positive results in 7.3% of cases with no prior HPV or cytologic lesions.
- A positive CINtec PLUS result was observed in 23.3% of cases with atypical squamous cells of undetermined significance (ASCUS) on PAP cytology.
- Overall, 36.5% of women screened using CINtec PLUS had a positive result, with over one-fifth of these being positive.
Conclusions:
- The CINtec PLUS test is a valuable tool for identifying high-risk cervical lesions.
- The study provides a foundation for further research into the long-term benefits and cost-effectiveness of CINtec PLUS.
- CINtec PLUS shows potential for integration into existing national cervical cancer screening programs.
