Next Article in Journal
Association Between Mitral Annular Calcification and Ventricular Tachycardia in Patients with Reduced and Mildly Reduced Ejection Fraction
Previous Article in Journal
Exploring the Balance Between Artificial Intelligence and Human Expertise in Shaping Breast Reconstruction Outcomes: A Comparative Reflection Study
 
 
Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
Journals
JCM
Volume 15
Issue 3
10.3390/jcm15031171
jcm-logo
Submit to this Journal Review for this Journal Propose a Special Issue
► Article Menu

Article Menu

share Share announcement Help format_quote Cite question_answer Discuss in SciProfiles
first_page
settings
Order Article Reprints
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Prospective Evaluation of Cytology, CINtec® and PD-L1 for the Detection of Cervical Intraepithelial Neoplasia: A Single-Center Study

by
Alexandru Hamod
1,
Mihaela Grigore
1,*,
Ingrid-Andrada Vasilache
1,
Ramona-Gabriela Ursu
1,
Oancea Mihaela
2,
Razvan Popovici
1,
Ana-Maria Grigore
1,
Ludmila Lozneanu
1,
Dan-Constantin Andronic
1 and
Manuela Ciocoiu
1
1
Grigore T. Popa University of Medicine and Pharmacy, 700115 Iasi, Romania
2
IInd Department of Obstetrics Gynecology, Iuliu Haţieganu University of Medicine and Pharmacy Cluj-Napoca, 13 Emil Isac, 400023 Cluj-Napoca, Romania
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2026, 15(3), 1171; https://doi.org/10.3390/jcm15031171
Submission received: 28 December 2025 / Revised: 22 January 2026 / Accepted: 30 January 2026 / Published: 2 February 2026
(This article belongs to the Section Obstetrics & Gynecology)
Versions Notes

Abstract

Background/Objectives: This study evaluated the diagnostic accuracy of cervical cytology, CINtec® (p16/Ki-67 dual staining), and PD-L1 immunohistochemistry, individually and in combination with high-risk HPV (HR-HPV) testing, for identifying histologically confirmed cervical lesions ranging from CIN1 to invasive carcinoma. Methods: We conducted a prospective cross-sectional study including 114 patients who underwent cervical cytology, CINtec®, PD-L1 staining, HPV genotyping, and histopathologic confirmation at a tertiary clinical center between September 2024 and September 2025. Sensitivity, specificity, PPV, NPV, and ROC performance were calculated for each test across lesion categories. Multivariable logistic regression models incorporating HR-HPV status were used to assess added predictive value. Results: All tests showed poor performance for CIN1 (cytology AUC 0.488; CINtec® 0.374; PD-L1 0.366). Diagnostic accuracy improved markedly with lesion severity. For CIN3, CINtec® demonstrated the highest discriminative ability (AUC 0.826), with cytology and PD-L1 also performing well (AUC 0.820 and 0.753). Cytology achieved the strongest ROC performance for CIN2+ (AUC 0.937), CIN3+ (0.913), and invasive carcinoma (0.887). PD-L1 consistently showed lower accuracy across categories. Cytology + HR-HPV demonstrated the highest AUC across all lesion categories. Conclusions: Cytology and CINtec® exhibited strong diagnostic accuracy for high-grade lesions, while PD-L1 showed limited utility as an independent screening marker. Combining cytology with HR-HPV testing enhanced predictive performance across all lesion categories. These findings support the continued use of cytology-based triage and highlight CINtec® as a valuable adjunct for high-grade disease detection. Because this study used a high-prevalence referral cohort, specificity may be overestimated and not representative of population-based screening.
Keywords: cervical intraepithelial neoplasia; screening; cytology; CINtec®; PD-L1 cervical intraepithelial neoplasia; screening; cytology; CINtec®; PD-L1

Share and Cite

MDPI and ACS Style

Hamod, A.; Grigore, M.; Vasilache, I.-A.; Ursu, R.-G.; Mihaela, O.; Popovici, R.; Grigore, A.-M.; Lozneanu, L.; Andronic, D.-C.; Ciocoiu, M. Prospective Evaluation of Cytology, CINtec® and PD-L1 for the Detection of Cervical Intraepithelial Neoplasia: A Single-Center Study. J. Clin. Med. 2026, 15, 1171. https://doi.org/10.3390/jcm15031171

AMA Style

Hamod A, Grigore M, Vasilache I-A, Ursu R-G, Mihaela O, Popovici R, Grigore A-M, Lozneanu L, Andronic D-C, Ciocoiu M. Prospective Evaluation of Cytology, CINtec® and PD-L1 for the Detection of Cervical Intraepithelial Neoplasia: A Single-Center Study. Journal of Clinical Medicine. 2026; 15(3):1171. https://doi.org/10.3390/jcm15031171

Chicago/Turabian Style

Hamod, Alexandru, Mihaela Grigore, Ingrid-Andrada Vasilache, Ramona-Gabriela Ursu, Oancea Mihaela, Razvan Popovici, Ana-Maria Grigore, Ludmila Lozneanu, Dan-Constantin Andronic, and Manuela Ciocoiu. 2026. "Prospective Evaluation of Cytology, CINtec® and PD-L1 for the Detection of Cervical Intraepithelial Neoplasia: A Single-Center Study" Journal of Clinical Medicine 15, no. 3: 1171. https://doi.org/10.3390/jcm15031171

APA Style

Hamod, A., Grigore, M., Vasilache, I.-A., Ursu, R.-G., Mihaela, O., Popovici, R., Grigore, A.-M., Lozneanu, L., Andronic, D.-C., & Ciocoiu, M. (2026). Prospective Evaluation of Cytology, CINtec® and PD-L1 for the Detection of Cervical Intraepithelial Neoplasia: A Single-Center Study. Journal of Clinical Medicine, 15(3), 1171. https://doi.org/10.3390/jcm15031171

Note that from the first issue of 2016, this journal uses article numbers instead of page numbers. See further details here.

Article Metrics

Article metric data becomes available approximately 24 hours after publication online.
Back to TopTop