Ramírez Arianis Tatiana, Mesher David, Baena Armando, Salgado Yuli, Kasamatsu Elena, Cristaldo Carmen, Álvarez Rodrigo, Rojas Freddy David, Ramírez Katherine, Guyot Julieta, Henríquez Odessa, González Palma Hans, Flores Bettsy, Peñaranda Jhaquelin, Vero María José, Robinson Isabel, Rol Mary Luz, Rodríguez Guillermo, Terán Carolina, Ferrera Annabelle, Picconi María Alejandra, Calderon Alejandro, Mendoza Laura, Wiesner Carolina, Almonte Maribel, Herrero Rolando
Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer, 69007 Lyon, France.
Blood Safety, Hepatitis, Sexually Transmitted Infections (STI) and HIV Division, UK Health Security Agency, E14 4PU London, United Kingdom.
J Natl Cancer Inst. 2025 Apr 1;117(4):644-652. doi: 10.1093/jnci/djae283.
Cervical cytology is recommended by the World Health Organization as a triage option in human papillomavirus (HPV)-based cervical cancer screening programs. We assessed the performance of cytology to detect CIN3+ without and with knowledge of HPV positivity.
Women were screened with cytology and HPV across ESTAMPA study centers 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 reinterpreted 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.
A total of 4087 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 to 51.9), whereas with knowledge of HPV positivity, the sensitivity was higher (58.9%, 95% CI = 54.2 to 63.5; P < .0001). The specificity without knowledge of HPV was 89.4% (95% CI = 88.2 to 90.5), whereas with knowledge of HPV positivity was 78.9% (95% CI = 77.4 to 80.4; P < .0001). Performance estimates varied by study center for cytology without knowing the HPV positivity (range = 32.8%-61.5% for sensitivity; range = 80.7%-98.6% for specificity). Similarly, performance varied with knowledge of HPV positivity (36.1%-93.4% for sensitivity; 39.6%-98.6% for specificity).
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.
世界卫生组织建议将宫颈细胞学检查作为基于人乳头瘤病毒（HPV）的宫颈癌筛查项目中的一种分流选择。我们评估了在不知道和知道HPV阳性结果的情况下，细胞学检查检测高级别宫颈上皮内瘤变（CIN3+）的性能。
在拉丁美洲的ESTAMPA研究中心，对女性进行了细胞学和HPV筛查。筛查呈阳性者根据需要转诊至阴道镜检查，并进行活检和治疗。细胞学检查最初在不知道HPV结果的情况下进行解读。来自HPV阳性女性的一部分细胞学检查在同一实验室重新解读，已知HPV状态，但对先前的细胞学和组织学诊断不知情。评估了在不知道和知道HPV阳性结果的情况下，细胞学检查检测CIN3+的性能指标。
共纳入4087名女性，其中490名经组织学证实为CIN3+（455例CIN3和35例癌症）。在不知道HPV阳性结果的情况下，细胞学检查对CIN3+的敏感性为47.2%（95%置信区间=42.5%至51.9%），而在知道HPV阳性结果的情况下，敏感性更高（58.9%，95%置信区间=54.2%至63.5%；P<0.0001）。在不知道HPV结果的情况下，特异性为89.4%（95%置信区间=88.2%至90.5%），而在知道HPV阳性结果的情况下，特异性为78.9%（95%置信区间=77.4%至80.4%；P<0.0001）。在不知道HPV阳性结果的情况下，各研究中心细胞学检查的性能估计值有所不同（敏感性范围为32.8%-61.5%；特异性范围为80.7%-98.6%）。同样，在知道HPV阳性结果的情况下，性能也有所不同（敏感性为36.1%-93.4%；特异性为39.6%-98.6%）。
了解HPV知识后细胞学检查敏感性的提高有限且差异很大，这进一步凸显了需要采用替代分流方法来支持消除宫颈癌目标。
