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Abstract：
OBJECTIVE: In this study, we aimed to validate the performance of the PAX1 and JAM3 methylation (PAX1m/JAM3m) test as a triage tool for detecting cervical intraepithelial neoplasia grade 3 or worse (CIN3 +) in non-16/18 high-risk human papillomavirus-positive patients (non-16/18 hrHPV +).
METHODS: The triage performance of liquid-based cytology (LBC) and the PAX1m/JAM3m test for detecting CIN3 + were compared.
RESULTS: In total, 1851 participants had cervical histological outcomes and were included in the analysis. The sensitivity/specificity of the LBC test results with atypical squamous cells of undetermined significance or worse (LBC ≥ ASCUS) and the PAX1m/JAM3m test were 90.1%/26.7% and 84.8%/88.5%, respectively. PAX1m/JAM3m( +) had the highest diagnostic AUC (0.866, 95% confidence interval (CI) 0.837-0.896) in the whole cohort. All cancers (n = 20) were detected by PAX1m/JAM3m(+). Compared with LBC ≥ ASCUS, PAX1m/JAM3m(+) reduced the number of patients who needed referral for colposcopy by 57.21% (74.66% vs. 17.45%). The odds ratios for detecting CIN3 + by LBC ≥ ASCUS and PAX1m/JAM3m(+) were 3.3 (95% CI 2.0-5.9) and 42.6 (27.1-69.6), respectively (p < 0.001). The combination of LBC ≥ ASCUS or PAX1m/JAM3m(+) slightly increased the diagnostic sensitivity (98.0%, 95% CI: 95.8-100%) and referral rate (77.09%) but reduced the diagnostic specificity (24.8%, 22.7-26.8%).
CONCLUSIONS: In non-16/18 hrHPV(+) women, PAX1m/JAM3m was superior to cytology for detecting CIN3 + . Compared with LBC ≥ ASCUS, PAX1m/JAM3m(+) reduced the number of significant referrals to colposcopy without compromising diagnostic sensitivity.
METHODS: The triage performance of liquid-based cytology (LBC) and the PAX1m/JAM3m test for detecting CIN3 + were compared.
RESULTS: In total, 1851 participants had cervical histological outcomes and were included in the analysis. The sensitivity/specificity of the LBC test results with atypical squamous cells of undetermined significance or worse (LBC ≥ ASCUS) and the PAX1m/JAM3m test were 90.1%/26.7% and 84.8%/88.5%, respectively. PAX1m/JAM3m( +) had the highest diagnostic AUC (0.866, 95% confidence interval (CI) 0.837-0.896) in the whole cohort. All cancers (n = 20) were detected by PAX1m/JAM3m(+). Compared with LBC ≥ ASCUS, PAX1m/JAM3m(+) reduced the number of patients who needed referral for colposcopy by 57.21% (74.66% vs. 17.45%). The odds ratios for detecting CIN3 + by LBC ≥ ASCUS and PAX1m/JAM3m(+) were 3.3 (95% CI 2.0-5.9) and 42.6 (27.1-69.6), respectively (p < 0.001). The combination of LBC ≥ ASCUS or PAX1m/JAM3m(+) slightly increased the diagnostic sensitivity (98.0%, 95% CI: 95.8-100%) and referral rate (77.09%) but reduced the diagnostic specificity (24.8%, 22.7-26.8%).
CONCLUSIONS: In non-16/18 hrHPV(+) women, PAX1m/JAM3m was superior to cytology for detecting CIN3 + . Compared with LBC ≥ ASCUS, PAX1m/JAM3m(+) reduced the number of significant referrals to colposcopy without compromising diagnostic sensitivity.
摘要：
目的：在本研究中，我们的目的是验证PAX1和JAM3甲基化(PAX1m/JAM3m)检测在非16/18高危人类乳头瘤病毒阳性患者(非16/18hrHPV+)中作为检测宫颈上皮内瘤变3级或更高级别(CIN3+)的分诊工具的性能.
方法：比较了液基细胞学（LBC）和PAX1m/JAM3m试验检测CIN3的分诊性能。
结果：总计，1851名参与者有宫颈组织学结局，并纳入分析。LBC检测结果对意义不明确或更差的非典型鳞状细胞(LBC≥ASCUS)和PAX1m/JAM3m检测的敏感性/特异性分别为90.1%/26.7%和84.8%/88.5%,分别。PAX1m/JAM3m(+)在整个队列中具有最高的诊断AUC(0.866,95%置信区间(CI)0.837-0.896)。所有癌症(n=20)均通过PAX1m/JAM3m(+)检测。与LBC≥ASCUS相比，PAX1m/JAM3m（）使需要转诊进行阴道镜检查的患者人数减少了57.21％（74.66％vs.17.45%）。LBC≥ASCUS和PAX1m/JAM3m(+)检测CIN3+的比值比为3.3(95%CI2.0-5.9)和42.6(27.1-69.6)，分别(p<0.001)。LBC≥ASCUS或PAX1m/JAM3m(+)的组合略微增加了诊断灵敏度(98.0%,95％CI：95.8-100％）和转诊率（77.09％），但降低了诊断特异性（24.8％，22.7-26.8%）。
结论：在非16/18hrHPV(+)女性中，PAX1m/JAM3m检测CIN3+优于细胞学。与LBC≥ASCUS相比，PAX1m/JAM3m(+)减少了转诊至阴道镜的显著次数而不影响诊断灵敏度。
方法：比较了液基细胞学（LBC）和PAX1m/JAM3m试验检测CIN3的分诊性能。
结果：总计，1851名参与者有宫颈组织学结局，并纳入分析。LBC检测结果对意义不明确或更差的非典型鳞状细胞(LBC≥ASCUS)和PAX1m/JAM3m检测的敏感性/特异性分别为90.1%/26.7%和84.8%/88.5%,分别。PAX1m/JAM3m(+)在整个队列中具有最高的诊断AUC(0.866,95%置信区间(CI)0.837-0.896)。所有癌症(n=20)均通过PAX1m/JAM3m(+)检测。与LBC≥ASCUS相比，PAX1m/JAM3m（）使需要转诊进行阴道镜检查的患者人数减少了57.21％（74.66％vs.17.45%）。LBC≥ASCUS和PAX1m/JAM3m(+)检测CIN3+的比值比为3.3(95%CI2.0-5.9)和42.6(27.1-69.6)，分别(p<0.001)。LBC≥ASCUS或PAX1m/JAM3m(+)的组合略微增加了诊断灵敏度(98.0%,95％CI：95.8-100％）和转诊率（77.09％），但降低了诊断特异性（24.8％，22.7-26.8%）。
结论：在非16/18hrHPV(+)女性中，PAX1m/JAM3m检测CIN3+优于细胞学。与LBC≥ASCUS相比，PAX1m/JAM3m(+)减少了转诊至阴道镜的显著次数而不影响诊断灵敏度。
