The p16/ki-67 assay is a safe, effective and rapid approach to triage women with mild cervical lesions

Autor: Ekaterini Magkana, Georgios Daskalakis, Alexandros Rodolakis, Andreas Pampanos, Ekaterini Domali, Kalliopi I. Pappa, Panagiota Mentzelopoulou, Maria Magkana
Rok vydání: 2021
Předmět:
Critical Care and Emergency Medicine
Economics
Biopsy
Social Sciences
Uterine Cervical Neoplasms
Cervix Uteri
Alphapapillomavirus
Pathology and Laboratory Medicine
0302 clinical medicine
Cytology
Medicine and Health Sciences
Early Detection of Cancer
Colposcopy
Cervical cancer
030219 obstetrics & reproductive medicine
Multidisciplinary
medicine.diagnostic_test
Obstetrics
Middle Aged
female genital diseases and pregnancy complications
Medical Microbiology
Viral Pathogens
030220 oncology & carcinogenesis
Viruses
Medicine
Female
Pathogens
Research Article
Adult
Genotyping
medicine.medical_specialty
Papillomaviruses
Science
Cytological Techniques
Surgical and Invasive Medical Procedures
Research and Analysis Methods
Microbiology
Young Adult
03 medical and health sciences
Health Economics
Signs and Symptoms
Statistical significance
Biomarkers
Tumor
medicine
Humans
Molecular Biology Techniques
Microbial Pathogens
Molecular Biology
Cyclin-Dependent Kinase Inhibitor p16
business.industry
Organisms
Biology and Life Sciences
Human Papillomavirus
Reproducibility of Results
Cell Biology
medicine.disease
Annual Screening
Health Care
Clinical trial
Ki-67 Antigen
Lesions
Triage
Clinical Medicine
DNA viruses
business
Ascus
Zdroj: PLoS ONE, Vol 16, Iss 6, p e0253045 (2021)
PLoS ONE
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0253045
Popis: Objective The aim of this study was to evaluate the diagnostic accuracy and efficiency of p16/ki-67 dual stain in the identification of CIN2+ lesions, in Greek women with ASCUS or LSIL cytology. Methods A total of 200 women, 20 to 60 years old, were enrolled in the study. All samples were cytologically evaluated and performed for p16/ki-67 and high-risk HPV (HR-HPV) test. All patients were referred to colposcopy for biopsy and histological evaluation. Three cervical cancer (CC) screening strategies were designed and the total direct medical costs of the procedures during our clinical trial were evaluated, from a healthcare perspective. Results HPV 16 as expected was the most common HR-HPV type followed by HPV 31 and HPV 51. The risk for CIN2+ was significantly higher in HPV 16/18 positive cases. p16/ki-67 demonstrated a high sensitivity for CIN2+ identification in both ASCUS and LSIL groups (90.4% and 95%, respectively). HR-HPV test with sensitivity 52.3% and 65.5%, as well as colposcopy with sensitivity 14.3% and 36% respectively in ASCUS and LSIL group, showed inferior results compared to p16/ki-67. The specificity of p16/ki-67 for ASCUS and LSIL was 97.2% and 95.2% respectively, inferior only to colposcopy: 100% and 100%, lacking however statistical significance. HR-HPV test instead, presented the lowest specificity: 76.4% and 71.4% respectively in comparison to the other two methods. From a healthcare perspective, the costs and benefits of the tests implementation for the annual screening and triaging, in three CC screening strategies, were also calculated and discussed. Conclusions The results of the study indicate that p16/ki-67 is a safe and rapid assay that could be used to detect CIN2+ among women with mild cervical lesions, presenting both high sensitivity and specificity and could minimize the psychological and economic burden of HPV screening.
Databáze: OpenAIRE
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