Evaluation of dual p16/Ki-67 immunostaining on anal cytology specimens

IF 1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY

Diagnostic Cytopathology Pub Date : 2024-04-26 DOI:10.1002/dc.25332

Marie C. Smithgall MD, William S. Towne MD, Abel A. Gonzalez MD, Adela Cimic MD

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引用次数: 0

Abstract

Introduction

Dual immunostaining for p16/Ki67 is FDA-approved for use on liquid-based cervical cytology specimens; however, the utility of dual staining in anal cytology especially for ASCUS risk stratification is not well established.

Methods

We investigated dual staining performance on anal cytology specimens and correlated with subsequent cytologic interpretation, high-risk HPV status, and anal biopsy results. Dual staining for p16/Ki-67 was performed on all liquid-based anal cytology specimens from December 2021 to June 2022 (n = 43).

Results

Three patients had high grade squamous intraepithelial lesion (HSIL/AIN2-3) on biopsy; dual staining was positive in all three cases. All HR-HPV negative cases were negative for dual staining. Among the 12 ASCUS samples with subsequent anal biopsy results all also had HR-HPV testing. Due to small sample size of cases with squamous intraepithelial lesion (SIL) diagnosed on biopsy, the sensitivity and positive predictive value was not calculated. However, the specificity and negative predictive value of p16/Ki-67 dual staining for SIL of any grade on biopsy were 1 (95% CI: 0.66–1) and 0.9 (95% CI: 0.65–0.97) respectively, whereas the specificity and negative predictive value of HR-HPV testing for SIL of any grade on biopsy were 0.44 (95% CI: 0.14–0.79) and 0.8 (95% CI: 0.41–0.96) respectively.

Conclusion

Dual p16/Ki-67 staining indicates transforming HPV infection and could help serve as an ancillary test for risk stratification for atypical anal cytology specimens. Among ASCUS samples, dual staining was specific for SIL of any grade with a high negative predictive value and therefore could be useful in clinical practices with limited availability for follow-up care.

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评估肛门细胞学标本上的 p16/Ki-67 双免疫染色。

引言p16/Ki67的双重免疫染色已获得FDA批准，可用于液基宫颈细胞学标本；然而，双重染色在肛门细胞学尤其是ASCUS风险分层中的实用性尚未得到很好的证实。方法我们研究了肛门细胞学标本的双重染色性能，并将其与随后的细胞学解释、高危HPV状态和肛门活检结果相关联。结果3例患者活检时发现高级别鳞状上皮内病变（HSIL/AIN2-3）；所有3例患者的双重染色均为阳性。所有 HR-HPV 阴性病例的双重染色均为阴性。在随后进行肛门活检的 12 例 ASCUS 样本中，所有样本都进行了 HR-HPV 检测。由于活检确诊为鳞状上皮内病变（SIL）的病例样本量较少，因此没有计算灵敏度和阳性预测值。然而，p16/Ki-67 双染色对活检任何级别 SIL 的特异性和阴性预测值分别为 1（95% CI：0.66-1）和 0.9（95% CI：0.65-0.97），而 HR-HPV 检测对活检任何级别 SIL 的特异性和阴性预测值分别为 0.结论p16/Ki-67双重染色提示转化型HPV感染，有助于作为非典型肛门细胞学标本风险分层的辅助检测。在ASCUS样本中，双重染色对任何级别的SIL都有特异性，且具有较高的阴性预测值，因此可用于后续护理有限的临床实践中。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diagnostic Cytopathology 医学-病理学

CiteScore

2.60

自引率

7.70%

发文量

163

审稿时长

3-6 weeks

期刊介绍： Diagnostic Cytopathology is intended to provide a forum for the exchange of information in the field of cytopathology, with special emphasis on the practical, clinical aspects of the discipline. The editors invite original scientific articles, as well as special review articles, feature articles, and letters to the editor, from laboratory professionals engaged in the practice of cytopathology. Manuscripts are accepted for publication on the basis of scientific merit, practical significance, and suitability for publication in a journal dedicated to this discipline. Original articles can be considered only with the understanding that they have never been published before and that they have not been submitted for simultaneous review to another publication.