Accuracy of combined molecular and morphology-based triage for HPV-positive women in routine cervical cancer screening services from Colombia
Accuracy of combined molecular and morphology-based triage for HPV-positive women in routine cervical cancer screening services from Colombia
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DOI：
10.1016/j.ypmed.2021.106801
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发表时间：
2021-09-21
影响因子：
5.1
通讯作者：
Wiesner, Carolina
中科院分区：
文献类型：
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作者：
Murillo, Rail;Gamboa, Oscar;Wiesner, Carolina
世卫组织消除宫颈癌的目标包括70%的高敏感性筛查覆盖率和90%的癌前病变治疗。对HPV阳性妇女的分诊可能会对筛查算法和妇女的后续行动的敏感性提出挑战，特别是在筛查质量和遵守方案经常不足的低收入和中等收入国家(LMIC)。我们的目标是通过一项前瞻性横断面研究，确定哥伦比亚常规筛查服务中对HPV阳性妇女进行分类的准确性。HPVDNA阳性妇女连续接受了六种分类策略(传统细胞学、两种肉眼检查方法、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定期阴道镜检查/活检。对CIN2+/CIN3+的调整敏感度、特异度和预测值分别进行了独立试验和联合试验评估。我们探讨了分类策略对转诊率的影响以及完整的筛选算法(筛选加分类)。总共有16,242名妇女接受了HPV筛查，其中1789人(11.0%)HPV阳性。总体而言，20.1%的女性失去了随访。阳性率最高(0.64)，敏感性最高(0.94 95%CI 0.75~0.96)，特异性最低(0.36 95%CI 0.29~0.43)。与HPV-mRNA平行检测显示，在所有分流策略中，敏感度增加最高。不同筛查单位细胞学和肉眼检查的准确性不同，但与HPV16/18/45基因分型平行检测显著提高了它们的敏感度(>0.80)。对于HPV阳性的妇女，如果结合HPV16/18/45基因分型，基于形态的分诊仍然是LMIC常规做法的合适选择；然而，护理点分诊将更可取，以减少随访的损失。HPV-mRNA分流值得进行成本效益分析。
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.