دورية أكاديمية

Evaluation of p16/Ki-67 dual-stained cytology as triage test for high-risk human papillomavirus-positive women.

التفاصيل البيبلوغرافية
العنوان: Evaluation of p16/Ki-67 dual-stained cytology as triage test for high-risk human papillomavirus-positive women.
المؤلفون: Ebisch RM; Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands., van der Horst J; Department of Pathology, Radboud University Medical Center, Nijmegen, The Netherlands., Hermsen M; Department of Pathology, Radboud University Medical Center, Nijmegen, The Netherlands., Rijstenberg LL; Department of Pathology, Radboud University Medical Center, Nijmegen, The Netherlands., Vedder JE; Department of Pathology, Radboud University Medical Center, Nijmegen, The Netherlands., Bulten J; Department of Pathology, Radboud University Medical Center, Nijmegen, The Netherlands., Bosgraaf RP; Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands., Verhoef VM; Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands., Heideman DA; Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands., Snijders PJ; Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands., Meijer CJ; Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands., van Kemenade FJ; Department of Pathology, Erasmus University Medical Center, Rotterdam, The Netherlands., Massuger LF; Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands., Melchers WJ; Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands., Bekkers RL; Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.; Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, The Netherlands., Siebers AG; Department of Pathology, Radboud University Medical Center, Nijmegen, The Netherlands.
المصدر: Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc [Mod Pathol] 2017 Jul; Vol. 30 (7), pp. 1021-1031. Date of Electronic Publication: 2017 Mar 17.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Inc Country of Publication: United States NLM ID: 8806605 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1530-0285 (Electronic) Linking ISSN: 08933952 NLM ISO Abbreviation: Mod Pathol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2023- : [New York] : Elsevier Inc.
Original Publication: Baltimore, MD : Williams & Wilkins, c1988-
مواضيع طبية MeSH: Cyclin-Dependent Kinase Inhibitor p16/*metabolism , Human papillomavirus 16/*isolation & purification , Ki-67 Antigen/*metabolism , Papillomavirus Infections/*complications , Uterine Cervical Neoplasms/*diagnosis , Uterine Cervical Dysplasia/*diagnosis, Adult ; Female ; Humans ; Middle Aged ; Papillomavirus Infections/metabolism ; Papillomavirus Infections/pathology ; Sensitivity and Specificity ; Triage ; Uterine Cervical Neoplasms/metabolism ; Uterine Cervical Neoplasms/pathology ; Uterine Cervical Neoplasms/virology ; Uterine Cervical Dysplasia/metabolism ; Uterine Cervical Dysplasia/pathology ; Uterine Cervical Dysplasia/virology
مستخلص: The aim of this study was to evaluate the clinical utility of p16/Ki-67 dual staining, for the identification of CIN in high-risk HPV-positive women from a non-responder screening cohort. P16/Ki-67 dual staining, Pap cytology, and HPV16/18 genotyping were performed on physician-taken liquid-based samples from 495 women who tested high-risk HPV positive on self-sampled material (PROHTECT-3B study). Different triage strategies involving p16/Ki-67 dual staining were evaluated for sensitivity, specificity, and predictive value for ≥CIN2 and ≥CIN3, and compared to Pap cytology with a threshold of atypical cells of undetermined significance. Centrally revised histology or an adjusted endpoint with combined high-risk HPV negative and cytology negative follow-up at 6 months was used as gold standard. Pap cytology (threshold atypical cells of undetermined significance) triage of high-risk HPV-positive samples showed a sensitivity of 93% (95% confidence interval: 85-98) with a specificity of 49% (95% confidence interval: 41-56) for ≥CIN3. Three triage strategies with p16/Ki-67 showed a significantly increased specificity with similar sensitivity. P16/Ki-67 triage of all high-risk HPV-positive samples had a sensitivity of 92% (95% confidence interval: 84-97) and a specificity of 61% (95% confidence interval: 54-69) for ≥CIN3. Applying p16/Ki-67 triage to only high-risk HPV-positive women with low-grade Pap cytology showed a similar sensitivity of 92% (95% confidence interval: 84-97), with a specificity for ≥CIN3 of 64% (95% confidence interval: 56-71). For high-risk HPV-positive women with low-grade and normal Pap cytology, triage with p16/Ki-67 showed a sensitivity of 96% (95% confidence interval: 89-99), and a specificity of 58% (95% confidence interval: 50-65). HPV16/18 genotyping combined with Pap cytology showed a sensitivity and specificity for ≥CIN3 similar to Pap cytology with an atypical cells of undetermined significance threshold. Because the quality of Pap cytology worldwide varies, and differences in sensitivity and specificity are limited between the three selected strategies, p16/Ki-67 triage of all high-risk HPV-positive samples would be the most reliable strategy in triage of high-risk HPV-positive women with an increased specificity and similar sensitivity compared with Pap cytology triage.
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المشرفين على المادة: 0 (CDKN2A protein, human)
0 (Cyclin-Dependent Kinase Inhibitor p16)
0 (Ki-67 Antigen)
تواريخ الأحداث: Date Created: 20170318 Date Completed: 20180411 Latest Revision: 20230210
رمز التحديث: 20231215
DOI: 10.1038/modpathol.2017.16
PMID: 28304400
قاعدة البيانات: MEDLINE
الوصف
تدمد:1530-0285
DOI:10.1038/modpathol.2017.16