Background Cervical cytology is recommended by WHO as a triage option in HPV-based cervical cancer screening programmes. We assessed the performance of cytology to detect CIN3+ without and with knowledge of HPV positivity. Methods Women were screened with cytology and HPV across ESTAMPA study centres in Latin America. Screen-positives were referred to colposcopy with biopsy and treatment as needed. Cytology was initially interpreted without knowing HPV results. A subset of cytologies from HPV-positive women were re-interpreted at the same laboratories, with knowledge of HPV status, blinded to previous cytology and histological diagnosis. Performance indicators for cytology to detect CIN3+ without and with knowledge of HPV positivity were estimated. Findings A total of 4,087 women were included, of which 490 had histologically confirmed CIN3 + (455 CIN3 and 35 cancers). Cytology sensitivity without knowledge of HPV positivity for CIN3+ was 47.2% (95% CI: 42.5-51.9), whereas with knowledge of HPV positivity, the sensitivity was higher (58.9%, 95% CI: 54.2-63.5), p < .0001. The specificity without knowledge of HPV was 89.4% (95% CI: 88.2-90.5), while with knowledge of HPV positivity was 78.9% (95% CI: 77.4-80.4), p < .0001. Performance estimates varied by study centre for cytology without knowing the HPV positivity, (range from 32.8% to 61.5% for sensitivity; range 80.7% to 98.6% for specificity). Similarly, performance varied with knowledge of HPV positivity (36.1% to 93.4% for sensitivity; 39.6% to 98.6% for specificity). Conclusion The increase in sensitivity of cytology with HPV knowledge was limited and highly variable, reinforcing the need for alternative triage methods to support cervical cancer elimination goals.

中文翻译：

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拉丁美洲 HPV 阳性知识对宫颈细胞学表现的影响


背景 WHO 建议将宫颈细胞学检查作为基于 HPV 的宫颈癌筛查规划的分诊选项。我们评估了细胞学检测 CIN3+ 的性能，而没有和知道 HPV 阳性。方法 在拉丁美洲的 ESTAMPA 研究中心对女性进行细胞学和 HPV 筛查。筛查阳性者转诊至阴道镜检查，并根据需要进行活检和治疗。细胞学检查最初是在不知道 HPV 结果的情况下进行解释的。来自HPV阳性女性的细胞学亚群在同一实验室重新解释，了解HPV状态，对先前的细胞学和组织学诊断不知情。估计细胞学检测 CIN3+ 的性能指标，无需和知道 HPV 阳性。结果共纳入 4,087 名女性，其中 490 名经组织学证实为 CIN3 +（455 名 CIN3 和 35 名癌症）。不知道 CIN3+ 的 HPV 阳性的细胞学敏感性为 47.2% （95% CI： 42.5-51.9），而知道 HPV 阳性的细胞学敏感性更高 （58.9%，95% CI： 54.2-63.5），p < .0001。不知道 HPV 的特异性为 89.4% （95% CI： 88.2-90.5），而知道 HPV 阳性的特异性为 78.9% （95% CI： 77.4-80.4），p < .0001。在不知道 HPV 阳性的情况下，细胞学研究中心的绩效估计各不相同（敏感性范围为 32.8% 至 61.5%;特异性范围为 80.7% 至 98.6%）。同样，表现因 HPV 阳性的了解而异 （敏感性为 36.1%-93.4%;特异性为 39.6%-98.6%）。结论 HPV 知识细胞学敏感性的增加是有限的且高度可变的，这加强了对替代分诊方法以支持宫颈癌消除目标的需求。