Interobserver variability and accuracy of p16/Ki-67 dual immunocytochemical staining on conventional cervical smears

Autor: Simona Hutter Čelik, Veronika Kloboves Prevodnik, Urška Ivanuš, Sandra Jezeršek, Živa Pohar Marinšek, Kristina Gornik Kramberger, Nataša Nolde, Alenka Repše Fokter, Tine Jerman, Ulrika Klopčič, Maja Primic Žakelj
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Adult
Immunocytochemical staining
Pathology
medicine.medical_specialty
Histology
Slovenia
Uterine Cervical Neoplasms
Cell morphology
Sensitivity and Specificity
Diagnostic accuracy
Pathology and Forensic Medicine
Agreement
03 medical and health sciences
Young Adult
0302 clinical medicine
Pregnancy
lcsh:Pathology
Medicine
Humans
Mass Screening
Cervical cancer screening
Cyclin-Dependent Kinase Inhibitor p16
p16/Ki-67
Colposcopy
Observer Variation
Vaginal Smears
Reproducibility
biology
medicine.diagnostic_test
business.industry
Research
Reproducibility of Results
General Medicine
Middle Aged
Cervical smears
Immunohistochemistry
Staining
030104 developmental biology
Ki-67 Antigen
030220 oncology & carcinogenesis
Ki-67
biology.protein
Female
Radiology
business
Kappa
lcsh:RB1-214
Zdroj: Diagnostic Pathology, Vol 14, Iss 1, Pp 1-9 (2019)
Diagnostic Pathology
ISSN: 1746-1596
DOI: 10.1186/s13000-019-0821-5
Popis: Background p16/Ki-67 dual immunocytochemical staining (DS) has been proven as a sensitive and specific test for triage of HPV positive women with good reproducibility and accuracy. However, implementation of the test into an organized screening program (OSP) is not easy. The aims of this study were to compare the performance and agreement of DS results among three Slovenian cytopathological laboratories involved in the national OSP, and to define cases where staining results can be difficult to interpret. Methods Cervical smears were obtained for DS from 129 women referred to colposcopy. Smears were evaluated blindly in three laboratories by a cytotechnologist and a cytopathologist after initial training. Results were positive, suspicious, negative or inadequate. Five characteristics of DS staining were recorded. After primary evaluation, an extensive expert-led additional training was undertaken, including a discussion of difficult cases and a practical exam. Smears were re-evaluated and results compared to primary evaluation. Results After the additional training, the overall percentage of agreement among the three laboratories increased from 77.5 to 89.9% and kappa increased from 0.70 to 0.86. Sensitivity for CIN2+ increased in two laboratories, to 90.5 and 85.7%, without the loss of specificity (75.8%). In one laboratory, the sensitivity slightly decreased from 90.5 to 88.9%, but the specificity increased from 63.6 to 68.2%. Difficult cases had significantly less DS cells, weak intensity of p16 staining, suboptimal cell morphology and background staining compared to positive cases. Conclusion Additional expert-led training and discussion of difficult cases are necessary for accurate interpretation of DS in laboratories involved in OSP. The most difficult cases were those with single stained cells and weak p16 staining. Training protocol for safe implementation of p16/Ki-67 DS in OSP is proposed. Electronic supplementary material The online version of this article (10.1186/s13000-019-0821-5) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje