Clinical utility of p16/Ki67 dual‐stain cytology for detection of cervical intraepithelial neoplasia grade two or worse in women with a transformation zone type 3: A cross‐sectional study
Objective To evaluate the clinical utility of p16/Ki67 dual‐stain (DS) compared with cytology for detecting cervical intraepithelial lesion grade two or worse (CIN2+) in women with a transformation zone type 3 (TZ3). Design Cross‐sectional study. Setting Colposcopy clinics in Central Denmark Region....
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| Published in: | BJOG : an international journal of obstetrics and gynaecology Vol. 130; no. 2; pp. 202 - 209 |
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| Main Authors: | , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
Wiley Subscription Services, Inc
01.01.2023
John Wiley and Sons Inc |
| Subjects: | |
| ISSN: | 1470-0328, 1471-0528, 1471-0528 |
| Online Access: | Get full text |
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| Summary: | Objective
To evaluate the clinical utility of p16/Ki67 dual‐stain (DS) compared with cytology for detecting cervical intraepithelial lesion grade two or worse (CIN2+) in women with a transformation zone type 3 (TZ3).
Design
Cross‐sectional study.
Setting
Colposcopy clinics in Central Denmark Region.
Population
Women aged 45 years or older referred for colposcopy because of an abnormal screening test.
Methods
All women had a cervical sample collected for cytology and DS testing and underwent large‐loop excision of the transformation zone (LLETZ).
Main outcome measure
Sensitivity, specificity and negative (NPV) and positive (PPV) predictive values of DS for CIN2+ detection were compared to those of cytology.
Results
Of 166 women eligible, 93 (56.0%) were included in the final analysis. Median age was 68 years (interquartile range [IQR] 63.4–70.5 years). Most women were postmenopausal (95.7%) and referred based on a positive human papillomavirus screening test (86.0%). Fifty‐two women (55.9%) were DS‐positive, 29 (55.8%) of whom had CIN2+ detected. Twenty‐seven (29.0%) women had atypical squamous cells of undetermined significance or worse (ASC‐US+), and CIN2+ was detected in 21 women (77.8%). DS had a higher sensitivity (96.7% versus 70.0% p = 0.021) and NPV (97.6% versus 86.4%, p = 0.018) compared with cytology for CIN2+ detection. In contrast, the specificity (63.5% versus 90.5% p < 0.001) and PPV (55.8% versus 77.8%, p = 0.001) were lower for DS compared with cytology.
Conclusions
Dual stain may be a valuable risk marker to guide clinical management of women with a TZ3. The superior NPV of DS suggests that a diagnostic excision may safely be avoided in DS‐negative women.
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DS‐negative postmenopausal women with a TZ3 have a low risk of CIN2+ and may undergo follow up instead of LLETZ. |
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| Bibliography: | Funding information Health Research Foundation of Central Denmark Region (A3234), Dagmar Marshalls Foundation, Fabricant Einar Willumsens Mindelegat, Else and Mogens Wedell‐Wedellsborgs Foundation, and A.P. Moller Foundation (18‐L‐0124) funded this project. None of the funders had influence on the scientific process, including the decision to submit the manuscript for publication. Roche Diagnostics sponsored the CINtec Plus test kits for this study and had the opportunity to comment on the article. Roche Diagnostics had no influence on the scientific process and no editorial rights pertaining to this manuscript. The authors retained the right to submit the manuscript. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 |
| ISSN: | 1470-0328 1471-0528 1471-0528 |
| DOI: | 10.1111/1471-0528.17248 |