Usefulness of P16 and KI67 Immunostaining in Cervical Smear Cytology in Guatemalan Women: A Cross-Sectional Study

G. Alberto, V. Angel, Quereda Francisco, O. Jaume, R. Orlando, Soch Erick, Morales H Arturo, Nave Federico, López-López Carlos
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Abstract

Background: Conventional cytology is an economic method for screening abnormalities in cervical smears, but with implications in false positive and false negative as compared to better detection of transformed cells with the Dual staining P16/KI67 proteins in cervical smears, therefore, we evaluate the validity and reproducibility of cytology with double staining of P16 and KI67 as compared to conventional cytology in cervical smears. Patients and methods: Participants were 210 Guatemalan women with abnormalities in conventional cytology (ASCUS, AGUS, ASCH, LSIL, HSIL, and cervical cancer) that consulted from 2013-2014 to the colposcopy Unit of Liga Nacional Contra El Cáncer e Instituto de Cancerología y Hospital Dr. Bernardo del Valle S. in Guatemala, from whom smear cytology was processed with P16 and KI67 immunostaining, and histological sections with P16 immunostaining as gold standard. They were evaluated by three blinded pathologists and one independent cytotechnologist. Results: The sensitivity and specificity of Dual staining P16/ KI67 for detecting abnormalities in cervical smears was 78.95%, 95% confidence interval (CI) 71.03-86.87 and 94.74%, 95%CI 89.06-100 respectively, as compare to conventional cytology in which it was 78.64% and 75.85%, respectively; positive predictive value (PPV) and negative predictive value (NPV) of Dual staining P16/KI67 were 95.74%, 95%CI 91.13-100.0 and 75%, 95%CI 65.82-84.18, as compare to conventional cytology in which it was 79.41% and 75% respectively. In women older than 30 years the sensitivity and PPV of Dual staining P16/KI67 was 78.43% and 95.24%, as compare in women less than 30 years in which it was 41.67% and 83.33% respectively. Interobserver agreement weighted Kappa indices for cervical smear cytology with double staining ranged between 0.66 to 0.83. Conclusion: Dual staining P16/KI67 in women older than 30 years showed better sensitivity and PPV values, suggesting greater utility in this age group, although the sensitivity was like conventional cytology, but with greater specificity and PPV.
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P16和KI67免疫染色在危地马拉妇女宫颈涂片细胞学检查中的作用:一项横断面研究
背景:传统细胞学是筛查宫颈涂片异常的一种经济方法,但与在宫颈涂片中用P16/KI67双染色蛋白更好地检测转化细胞相比,有假阳性和假阴性的影响,因此,我们评估了P16和KI67双重染色的细胞学检查在宫颈涂片中与传统细胞学检查相比的有效性和可重复性。患者和方法:参与者是210名传统细胞学异常的危地马拉妇女(ASCUS、AGUS、ASCH、LSIL、HSIL和宫颈癌症),她们于2013-2014年咨询了危地马拉国家癌症研究所和医院Bernardo del Valle S.医生的阴道镜检查室,对其进行了P16和KI67免疫染色,以及P16免疫染色作为金标准的组织学切片。他们由三名失明的病理学家和一名独立的细胞技术专家进行评估。结果:P16/KI67双染色法检测宫颈涂片异常的敏感性和特异性分别为78.95%,95%可信区间(CI)为71.03-86.87和94.74%,95%CI为89.06-100,而常规细胞学检查的敏感性和特异度分别为78.64%和75.85%;双染色P16/KI67的阳性预测值(PPV)和阴性预测值(NPV)分别为95.74%,95%CI 91.13-100.0和75%,95%CI 65.82-84.18,而常规细胞学分别为79.41%和75%。P16/KI67双染色在30岁以上妇女中的敏感性和PPV分别为78.43%和95.24%,而在30岁以下妇女中的灵敏度和PPV则分别为41.67%和83.33%。双染色宫颈涂片细胞学的观察者间一致性加权Kappa指数在0.66至0.83之间。结论:P16/KI67双染色在30岁以上女性中显示出更好的敏感性和PPV值,表明在该年龄组中有更大的实用性,尽管敏感性与传统细胞学相似,但具有更高的特异性和PPV。
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