Validation of CINtec® plus cytology kit in the diagnosis of persistent HPV infections-Cohort study in the Portuguese population

Abstract

Context: The use of the CINtec® PLUS Cytology Kit as a complementary method of diagnosis is intended to contribute to a risk assessment of CIN II+ cervical lesions development, thus avoiding unnecessary colposcopy in negative cases. This method has proved to be effective in the follow-up of cervical lesions, although there is need for consistency in the approach of equivocal or negative cytological results, with persistent positive High-Risk Human Papillomavirus (HR-HPV) test. Aims: The present study intends to retrospectively evaluate the capacity of the CINtec® to add information to the clinical practice within the screening and follow-up of cervical lesions. Additionally, this study intends to define criteria for CINtec® referral in order to maximize its utilization in the Portuguese context. Materials and Methods: For this purpose, 225 cases with CINtec® PLUS Cytology Kit and histology results were used, and data were analysed and compared according to the cytology and HR-HPV molecular test results. Results: The data of this study show that CINtec® PLUS Cytology Kit is a valid test for the diagnosis of persistent HPV lesions (p = 0.0005), with excellent sensitivity and reliable values of specificity. Relevant patient groups to apply the kit are in agreement with the manufacturer recommendations: Women with ASC-US/LSIL result and NILM cytology with HPV-positive test, essentially over 30 years old. Conclusions: Although clinical data and previous cytological information must help guiding, authors considered that CINtec® is a really valid test for the prognosis of persistent HPV infections in the female population.