p16/Ki-67 dual staining in cervico-vaginal cytology: Correlation with histology, Human Papillomavirus detection and genotyping in women undergoing colposcopy
p16/Ki-67 dual staining in cervico-vaginal cytology: Correlation with histology, Human Papillomavirus detection and genotyping in women undergoing colposcopy
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DOI：
10.1016/j.ygyno.2012.05.004
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发表时间：
2012-08-01
影响因子：
4.7
通讯作者：
Benevolo, Maria
中科院分区：
文献类型：
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作者：
Dona, Maria Gabriella;Vocaturo, Amina;Benevolo, Maria
目标。目的评价宫颈液基细胞学中同时检测p16(INK4a)和Ki-67的免疫细胞化学新方法CINTEC(R)PLUS(MTM Labels)，探讨双重染色与HPV感染、基因分型及细胞学和组织学异常的关系。140名妇女在阴道镜检查前立即采集了宫颈阴道样本。采用线阵HPV基因分型试验、CINTEC(R)PLUS试剂盒双重染色和细胞学检查进行HPV检测。细胞学检查结果为NILM 38例，ASC-US 16例，L-sIL 32例，H-sIL 54例或更差。阴道镜引导下活检113例，其中阴性14例，CIN1 35例，CIN2 24例，CIN3 37例，侵袭性鳞癌3例。P16/Ki-67与HR-HPV感染密切相关(COR=6.86，95%CI：1.84~31.14)。重要的是，p16/Ki-67阳性与HPV16和/或18感染的相关性是其他HR-HPV感染的2倍(COR=9.92，95%CI：2.39~47.77 vs COR=4.20，95%CI：0.99~20.87)。此外，p16/Ki-67的阳性率随细胞学和组织学异常程度的加重而显著升高(p
Objectives. To evaluate the CINtec (R) PLUS assay (mtm laboratories), a new immunocytochemical method for the simultaneous detection of p16(INK4a) and Ki-67, in liquid-based cervico-vaginal cytology, investigating the association of the dual staining with HPV infection and genotyping as well as cytological and histological abnormalities.Methods. 140 women with a cervico-vaginal sample obtained immediately before the colposcopy were enrolled. This cytological sample was used for HPV testing with the Linear Array HPV Genotyping Test, the dual staining with the CINtec (R) PLUS kit and the morphology assessment.Results. Cytology results were 38 NILM, 16 ASC-US, 32L-SIL, 54H-SIL or worse. 113 patients also had a colposcopy-guided biopsy, classified as 14 negative, 35 CIN1, 24 CIN2, 37 CIN3, 3 invasive SCC. A strong association between p16/Ki-67 and HR-HPV infection was found (COR=6.86, 95% Cl: 1.84-31.14). Importantly, the association between p16/Ki-67 positivity and HPV16 and/or 18 infection was 2-fold stronger compared to that with the infection by other HR-HPV types (COR=9.92, 95% Cl: 2.39-47.77 vs COR = 4.20, 95% Cl: 0.99-20.87). In addition, p16/Ki-67 positivity rate significantly increased with the severity of the cytological and histological abnormalities (p