PDF(Pubmed)
Abstract：
OBJECTIVE: To assess the clinical values of extended human papillomavirus (HPV) genotyping in triage of high-risk HPV-positive women, focusing on the trade-off between cervical precancer detections and colposcopy referrals.
METHODS: A bivariate random-effects model was used to estimate the diagnostic accuracy of primary HPV screening with following triage strategies to detect cervical precancers: (i) partial genotyping for HPV16/18 combined with cytological testing at atypical squamous cells of undetermined significance threshold (used as the comparator), (ii) genotyping for HPV16/18/58/52, (iii) genotyping for HPV16/18/58/52/33, (iv) genotyping for HPV16/18/58/33/31, (v) genotyping for HPV16/18/58/52/33/31, and (vi) genotyping for HPV16/18/58/52/33/31/39/51. Internal risk benchmarks for clinical management were used to evaluate the risk stratification of each triage strategy.
RESULTS: A total of 16,982 women (mean age 46.1 years, range 17-69) were included in this analysis. For CIN3+ detection, triage with HPV16/18/58/33/31 genotyping achieved lower positivity (6.85% vs. 7.35%, p = 0.001), while maintaining similar sensitivity (91.35% vs. 96.42%, p = 0.32) and specificity (94.09% vs. 93.67%, p = 0.56) compared with the comparator strategy. Similar patterns were observed for CIN2+ detection. Women with a positive HPV16/18/58/33/31 genotyping test had high enough risk for CIN3+ for colposcopy referral, while the risk for women with a negative test was below the 1-year return decision threshold according to internal benchmarks.
CONCLUSIONS: Our findings suggested extended HPV genotyping is of potential to be used as a triage technique integrated into HPV-based cervical cancer screening, leading to reduced need for colposcopy referral while maintaining similar disease detection and efficient risk stratification.
METHODS: A bivariate random-effects model was used to estimate the diagnostic accuracy of primary HPV screening with following triage strategies to detect cervical precancers: (i) partial genotyping for HPV16/18 combined with cytological testing at atypical squamous cells of undetermined significance threshold (used as the comparator), (ii) genotyping for HPV16/18/58/52, (iii) genotyping for HPV16/18/58/52/33, (iv) genotyping for HPV16/18/58/33/31, (v) genotyping for HPV16/18/58/52/33/31, and (vi) genotyping for HPV16/18/58/52/33/31/39/51. Internal risk benchmarks for clinical management were used to evaluate the risk stratification of each triage strategy.
RESULTS: A total of 16,982 women (mean age 46.1 years, range 17-69) were included in this analysis. For CIN3+ detection, triage with HPV16/18/58/33/31 genotyping achieved lower positivity (6.85% vs. 7.35%, p = 0.001), while maintaining similar sensitivity (91.35% vs. 96.42%, p = 0.32) and specificity (94.09% vs. 93.67%, p = 0.56) compared with the comparator strategy. Similar patterns were observed for CIN2+ detection. Women with a positive HPV16/18/58/33/31 genotyping test had high enough risk for CIN3+ for colposcopy referral, while the risk for women with a negative test was below the 1-year return decision threshold according to internal benchmarks.
CONCLUSIONS: Our findings suggested extended HPV genotyping is of potential to be used as a triage technique integrated into HPV-based cervical cancer screening, leading to reduced need for colposcopy referral while maintaining similar disease detection and efficient risk stratification.
摘要：
目的：评估扩展型人乳头瘤病毒（HPV）基因分型在高危型HPV阳性女性分诊中的临床价值，专注于宫颈癌前病变检测和阴道镜转诊之间的权衡。
方法：使用双变量随机效应模型来评估原发性HPV筛查的诊断准确性，并采用以下分诊策略来检测宫颈癌前病变：（i）HPV16/18的部分基因分型结合细胞学检测在意义阈值未确定的非典型鳞状细胞（用作比较），(ii)HPV16/18/58/52的基因分型,(iii)HPV16/18/58/52/33的基因分型,(iv)HPV16/18/58/33/31的基因分型,(v)HPV16/18/58/52/33/31的基因分型,和(vi)HPV16/18/58/52/33/31/39/51的基因分型。使用临床管理的内部风险基准来评估每种分诊策略的风险分层。
结果：共有16,982名妇女（平均年龄46.1岁，范围17-69）包括在此分析中。ForCIN3+检测，HPV16/18/58/33/31基因分型的分诊阳性率较低(6.85%vs.7.35%，p=0.001),同时保持相似的灵敏度(91.35%vs.96.42%,p=0.32）和特异性（94.09%vs.93.67%,p=0.56)与比较器策略相比。对于CIN2+检测观察到类似的模式。HPV16/18/58/33/31基因分型试验阳性的女性对于阴道镜转诊的CIN3+有足够高的风险，而根据内部基准，检测阴性的女性的风险低于1年返回决策阈值。
结论：我们的研究结果表明，扩展HPV基因分型有可能被用作一种整合到基于HPV的宫颈癌筛查中的分诊技术。导致减少对阴道镜转诊的需要，同时保持相似的疾病检测和有效的风险分层。
方法：使用双变量随机效应模型来评估原发性HPV筛查的诊断准确性，并采用以下分诊策略来检测宫颈癌前病变：（i）HPV16/18的部分基因分型结合细胞学检测在意义阈值未确定的非典型鳞状细胞（用作比较），(ii)HPV16/18/58/52的基因分型,(iii)HPV16/18/58/52/33的基因分型,(iv)HPV16/18/58/33/31的基因分型,(v)HPV16/18/58/52/33/31的基因分型,和(vi)HPV16/18/58/52/33/31/39/51的基因分型。使用临床管理的内部风险基准来评估每种分诊策略的风险分层。
结果：共有16,982名妇女（平均年龄46.1岁，范围17-69）包括在此分析中。ForCIN3+检测，HPV16/18/58/33/31基因分型的分诊阳性率较低(6.85%vs.7.35%，p=0.001),同时保持相似的灵敏度(91.35%vs.96.42%,p=0.32）和特异性（94.09%vs.93.67%,p=0.56)与比较器策略相比。对于CIN2+检测观察到类似的模式。HPV16/18/58/33/31基因分型试验阳性的女性对于阴道镜转诊的CIN3+有足够高的风险，而根据内部基准，检测阴性的女性的风险低于1年返回决策阈值。
结论：我们的研究结果表明，扩展HPV基因分型有可能被用作一种整合到基于HPV的宫颈癌筛查中的分诊技术。导致减少对阴道镜转诊的需要，同时保持相似的疾病检测和有效的风险分层。
