Centro Javeriano de Oncología - Hospital Universitario San Ignacio, Bogotá, Colombia; Facultad de Medicina - Pontificia Universidad Javeriana, Bogotá, Colombia.
Servicio de Radioterapia - Instituto Nacional de Cancerología, Bogotá, Colombia.
Prev Med. 2021 Dec;153:106801. doi: 10.1016/j.ypmed.2021.106801. Epub 2021 Sep 8.
WHO cervical cancer elimination goals comprise 70% of highly-sensitive screening coverage and 90% treatment of precancerous lesions. Triage for HPV-positive women may challenge sensitivity of screening algorithms and women's follow-up, particularly in low- and middle-income countries (LMIC) where screening quality and protocol adherence are frequently deficient. We aimed to determine the accuracy of triage for HPV positive women in routine screening services from Colombia by a prospective cross-sectional study. Consecutively, HPV DNA-positive women underwent six triage strategies (conventional cytology, two methods of visual inspection, HPV16/18/45-genotyping, telomerase, and HPV mRNA). Positive triage results underwent regular colposcopy/biopsy in public hospitals. Adjusted sensitivity, specificity, and predictive values for CIN2+/CIN3+ were estimated for stand-alone and combined tests. We explored the impact of triage strategies on referral rates and the complete screening algorithm (screening plus triage). Overall 16,242 women underwent HPV screening and 1789 (11.0%) were HPV-positive. In total, 20.1% of women were lost to follow-up. mRNA showed the highest positivity rate (0.64 among HPV-positive and 0.05 among the total screened cohort), the highest sensitivity (0.94 95%CI 0.75-0.96), and the lowest specificity (0.36 95%CI 0.29-0.43). Parallel testing with HPV-mRNA revealed the highest increase in sensitivity for all triage strategies. Accuracy of cytology and visual inspection differ between screening units but parallel testing with HPV16/18/45 genotyping significantly increased their sensitivity (over 0.80). Morphology-based triage for HPV-positive women remains a suitable alternative for routine practice in LMIC if combined with HPV16/18/45-genotyping; however, point-of-care triage would be preferable to reduce losses to follow-up. HPV-mRNA triage deserves cost-benefit analyses.
世界卫生组织（WHO）的宫颈癌消除目标包括 70%的高敏感筛查覆盖率和 90%的癌前病变治疗率。对 HPV 阳性女性进行分流可能会挑战筛查算法和女性随访的敏感性，特别是在筛查质量和方案依从性经常不足的中低收入国家（LMIC）。我们旨在通过一项前瞻性横断面研究来确定哥伦比亚常规筛查服务中对 HPV 阳性女性进行分流的准确性。连续地，HPV DNA 阳性女性接受了六种分流策略（传统细胞学检查、两种肉眼观察方法、HPV16/18/45 基因分型、端粒酶和 HPV mRNA）。阳性分流结果在公立医院接受常规阴道镜检查/活检。估计了单独和联合检测对 CIN2+/CIN3+的调整灵敏度、特异性和预测值。我们探讨了分流策略对转诊率和完整筛查算法（筛查加分流）的影响。共有 16242 名女性接受了 HPV 筛查，其中 1789 名（11.0%）HPV 阳性。共有 20.1%的女性失访。mRNA 的阳性率最高（HPV 阳性者为 0.64，总筛查队列为 0.05），灵敏度最高（0.94 95%CI 0.75-0.96），特异性最低（0.36 95%CI 0.29-0.43）。与 HPV-mRNA 平行检测可显著提高所有分流策略的灵敏度。细胞学和肉眼观察的准确性在不同的筛查单位之间存在差异，但与 HPV16/18/45 基因分型平行检测可显著提高其灵敏度（超过 0.80）。如果与 HPV16/18/45 基因分型相结合，基于形态的 HPV 阳性女性分流仍然是 LMIC 常规实践的一种合适替代方法；然而，为了减少失访，即时检测分流更为可取。HPV-mRNA 分流值得进行成本效益分析。
