Journal of Cytology
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ORIGINAL ARTICLE
Year : 2021  |  Volume : 38  |  Issue : 2  |  Page : 94-100

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


1 Department of Pathological, Cytological and Thanatological Anatomy, School of Health of the Polytechnic Institute of Porto, Porto, Portugal
2 Department of Pathological, Cytological and Thanatological Anatomy, School of Health of the Polytechnic Institute of Porto; Research Centre in Health and Environment/ Centro de Investigação em Saúde e Ambiente (CISA), Porto, Portugal

Correspondence Address:
Prof. Sílvia Fernandes
Department of Pathological, Cytological and Thanatological Anatomy, School of Health of the Polytechnic Institute of Porto, Rua Dr. António Bernardino de Almeida, nº 400, 4200-072 Porto
Portugal
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JOC.JOC_173_20

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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.


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