CINtec PLUS在细胞学解释阴性患者短期随访中识别高级别病变的应用。

IF 1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY

Diagnostic Cytopathology Pub Date : 2025-03-03 DOI:10.1002/dc.25457

Niyati Desai, William Towne, Courtney F. Connelly, Swikrity U. Baskota, John P. Crapanzano, Kanan Desai, Adela Cimic

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引用次数: 0

摘要

背景：宫颈癌筛查可能包括宫颈细胞学检查和/或高危人乳头瘤病毒检测（HPV）。FDA（食品和药物管理局）批准的p16和Ki-67 CINtec PLUS双染色（DS）可以为具有挑战性的后续护理提供有用的信息。方法：回顾性分析272例上皮内恶性肿瘤（NILM）巴氏试验阴性和HPV检测阳性的病例。所有272名妇女在一年内进行了阴道镜指导下的活检或宫颈内膜刮除（ECC）（组织病理学）。我们将DS测试结果与相应的ECC/阴道镜标本进行比较。进行了两个亚组分析，以检查DS结果与Pap/阴道镜异常病史的相关性，并比较DS结果与HPV基因型的关系。为了分析目的，只有高级别病变被认为是阳性的，而低级别病变被归为阴性结果。结果：272例患者中，DS阳性113例，阴性159例。在一年内的随访组织病理学中，113例阳性病例中有3例（2.6%）显示高度病变。相比之下，159例阴性病例均未出现任何高级病变（95%置信区间[CI]: -0.3%至5.4% [p = 0.14]）。进一步的HPV状态分析显示，DS有助于两个亚类（HPV16/18和其他12种高危HPV）的风险区分，尽管没有统计学意义（p = 0.99）。基于高级别病变史的亚组分析显示，在没有既往病史的病例中，DS阳性和阴性结果的风险差异为2.8% （95% CI -0.3%至6%，p = 0.134）。结论：所有3个高级别病变均为DS阳性，提示DS可能有助于hpv阳性NILM妇女（HPV16/18或其他）的风险分层。此外，DS可能有助于风险分层，特别是对于先前没有高级别病变的患者。

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Utility of CINtec PLUS in Identification of High-Grade Lesions on Short-Term Follow-Up in Patients With Negative Cytologic Interpretation

Background

Screening for cervical cancer may include cervical cytology and/or high-risk human papillomavirus testing (HPV). The FDA (Food and Drug Administration)-approved CINtec PLUS dual stain (DS) for p16 and Ki-67 can provide helpful information for challenging follow-up care.

Methods

We retrospectively analyzed 272 cases with negative intraepithelial malignancy (NILM) Papanicolaou (Pap) tests and positive HPV test results. All 272 women had colposcopy-directed biopsies or endocervical curettage (ECC) (histopathology) within a year. We compared DS test results with corresponding ECC/colposcopy specimens. Two subgroup analyses were conducted to examine the correlation of DS results with a prior history of abnormal Pap/colposcopy and to compare DS results with regard to HPV genotype. For analysis purposes, only high-grade lesions were considered positive, while low-grade lesions were grouped with negative results.

Results

Of 272 cases, 113 tested positive for DS, while 159 were negative. On follow-up histopathology within a year, three of the 113 positive cases (2.6%) showed high-grade lesions. In comparison, none of the 159 negative cases showed any high-grade lesions (95% confidence interval [CI]: −0.3% to 5.4% [p = 0.14]). Further analysis by HPV status showed that DS helped in risk discrimination in both subcategories (HPV16/18 and other 12 high-risk HPV), although it was not statistically significant (p = 0.99). Subgroup analysis based on the history of high-grade lesions demonstrated that in cases with no previous history, the risk difference was 2.8% between DS positive and negative results (95% CI −0.3% to 6%, p = 0.134).

Conclusion

All three high-grade lesions were in the DS positive category, suggesting DS may help in the risk stratification for HPV-positive NILM women (either HPV16/18 or other). Furthermore, DS may help with risk stratification, specifically in patients with no prior high-grade lesions.

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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.