评估 CinTec® PLUS 在 SurePathTM 液基宫颈阴道样本中的性能。

Evaluation of the Performance of CinTec® PLUS in SurePathTM Liquid-Based Cervico-Vaginal Samples.

机构信息

Department of Cytology and Gynecological Pathology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Turk Patoloji Derg. 2021;37(1):32-38. doi: 10.5146/tjpath.2020.01505.

DOI:10.5146/tjpath.2020.01505

PMID:33372263

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10508926/

Abstract

OBJECTIVE

Cervical cytology and Human papillomavirus (HPV) testing are effective screening techniques but both have limitations. A few recent studies in the literature have highlighted the role of co-expression of p16INK4a and Ki-67 for cervical cancer screening. The present study was undertaken to evaluate the diagnostic performance of the CINtec® PLUS kit (dual immunostaining for p16 and Ki-67) in SurePathTM liquid-based (LBC) cervico-vaginal samples.

MATERIALS AND METHODS

This was a prospective study performed on 52 cervico-vaginal SurePath™ LBC samples reported as having squamous epithelial cell abnormality (ECA). All the samples were stained using CINtec® PLUS kits. Additionally, HPV-DNA testing was also done and the results were compared.

RESULTS

The age range was 34-74 years. ECA included 18 (34.6%) cases of ASC-US, 9 (17.3%) cases of low-grade squamous intraepithelial lesion (LSIL), 11 (21.2%) cases of high-grade squamous intraepithelial lesion (HSIL), and 14 (26.9%) cases of squamous cell carcinoma (SCC). Cervical biopsies were available in 19 (36.5%) cases. A total of 34/52 (65.4%) cases were positive for HPV-DNA (5/18-ASC-US; 6/9-LSIL; 10/11-HSIL; 13/14-SCC). The CINtec® PLUS test was positive in 41/52 (78.8%) cases (11/18-ASC-US; 6/9-LSIL; 11/11-HSIL; 13/14-SCC). On comparing CINtec® PLUS positivity (78.8%) with HPV positivity (65.4%), dual positivity was seen in 3/18 cases of ASC-US, 6/9 cases of LSIL, 10/11 cases of HSIL, and 12/14 cases of SCC. One case each of HSIL and SCC was negative on the HPV test and was positive on CINtec® PLUS.

CONCLUSIONS

CINtec® PLUS test helps to improve the detection of pre-cancerous cervical lesions as compared to cervical cytology or HPV testing alone and hence can serve as a potentially useful diagnostic and triage tool, especially for indeterminate cases.

摘要

目的

宫颈细胞学和人乳头瘤病毒（HPV）检测是有效的筛查技术，但都存在局限性。一些最近的文献研究强调了 p16INK4a 和 Ki-67 共表达在宫颈癌筛查中的作用。本研究旨在评估 CINtec® PLUS 试剂盒（p16 和 Ki-67 的双重免疫染色）在 SurePathTM 液基（LBC）宫颈阴道样本中的诊断性能。

材料和方法

这是一项对 52 例宫颈阴道 SurePathTM LBC 样本进行的前瞻性研究，这些样本报告为鳞状上皮细胞异常（ECA）。所有样本均使用 CINtec® PLUS 试剂盒进行染色。此外，还进行了 HPV-DNA 检测，并对结果进行了比较。

结果

年龄范围为 34-74 岁。ECA 包括 18 例（34.6%）非典型鳞状细胞（ASC-US）、9 例（17.3%）低度鳞状上皮内病变（LSIL）、11 例（21.2%）高度鳞状上皮内病变（HSIL）和 14 例（26.9%）鳞状细胞癌（SCC）。19 例（36.5%）有宫颈活检。共有 34/52 例（65.4%）HPV-DNA 阳性（5/18-ASC-US；6/9-LSIL；10/11-HSIL；13/14-SCC）。CINtec® PLUS 检测阳性 41/52 例（78.8%）（11/18-ASC-US；6/9-LSIL；11/11-HSIL；13/14-SCC）。比较 CINtec® PLUS 阳性（78.8%）与 HPV 阳性（65.4%），在 3 例 ASC-US、6 例 LSIL、10 例 HSIL 和 12 例 SCC 中发现双重阳性。1 例 HSIL 和 1 例 SCC 在 HPV 检测中为阴性，而在 CINtec® PLUS 检测中为阳性。