The Lower Anogenital Squamous Terminology (LAST) Project recommends the use of p16 immunohistochemistry as an adjunct to morphologic assessment of cervical biopsies according to a specific set of criteria. We analyzed the effect of adjunctive p16 according to LAST criteria in a US-based diagnostic utility study involving 70 surgical pathologists providing a total of 38,500 reads on cervical biopsies. Compared with the results obtained using hematoxylin and eosin-stained slides only, including p16-stained slides per LAST criteria increased sensitivity and specificity for diagnosing histologic high-grade squamous intraepithelial lesions across all cases by 8.1% (95% confidence interval [95% CI], 6.5-9.7; P<0.0001) and 3.5% (95% CI, 2.8-4.2; P<0.0001), respectively, using expert consensus diagnoses on hematoxylin and eosin+p16 as reference. Within the subset of cases classified by the pathologists as fulfilling the LAST criteria, adding p16 significantly increased both sensitivity (+11.8%; 95% CI, 9.5-14.0; P<0.0001) and specificity (+9.7%; 95% CI, 7.8-11.5; P<0.0001). However, a comparable improvement in sensitivity (+11.0%; 95% CI, 7.8-14.1; P<0.0001) was found when p16 was used in cases for which p16 staining was not ordered per LAST by the pathologists, whereas specificity decreased by -0.8% (95% CI, -1.1 to -0.5; P<0.0001). The study demonstrates a clinically and statistically significant increase in sensitivity and specificity for high-grade squamous intraepithelial lesion when p16 is used according to LAST criteria. Expanding the use of p16 into non-LAST cases would lead to a comparable improvement in sensitivity within this subgroup of biopsies, at the cost of a minimal, but statistically significant difference in specificity.

中文翻译：

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某些研究结果：根据 LAST 标准，辅助 p16 免疫组织化学在宫颈活检中的应用。

下肛门生殖器鳞状细胞术语 (LAST) 项目建议使用 p16 免疫组织化学作为根据一组特定标准对宫颈活检进行形态学评估的辅助手段。我们在一项基于美国的诊断效用研究中根据 LAST 标准分析了辅助 p16 的影响，该研究涉及 70 名外科病理学家，提供总共 38,500 次宫颈活检读数。与仅使用苏木精和伊红染色的载玻片获得的结果相比，包括按照 LAST 标准的 p16 染色载玻片，诊断所有病例的组织学高级鳞状上皮内病变的敏感性和特异性提高了 8.1%（95% 置信区间 [95% CI ], 6.5-9.7; P<0.0001) 和 3.5% (95% CI, 2.8-4.2; P<0.0001)，使用专家对苏木精和伊红+p16 的共识诊断作为参考。在病理学家分类为满足 LAST 标准的病例子集中，添加 p16 显着提高了敏感性（+11.8%；95% CI，9.5-14.0；P<0.0001）和特异性（+9.7%；95% CI，7.8 -11.5；P<0.0001)。然而，当病理学家没有根据 LAST 对 p16 染色进行染色的情况下使用 p16 时，发现灵敏度有相当的改善（+11.0%；95% CI，7.8-14.1；P<0.0001），而特异性降低 - 0.8%（95% CI，-1.1 至 -0.5；P<0.0001）。该研究表明，当根据 LAST 标准使用 p16 时，对高级别鳞状上皮内病变的敏感性和特异性在临床和统计学上均显着增加。将 p16 的使用扩展到非 LAST 病例将导致该活检亚组中敏感性的可比改善，