阴道自取样人乳头瘤病毒检测用于子宫颈癌筛查与医取样的效果比较

Comparison of HPV vaginal self-sampling and physician-sampling for cervical cancer screening

目的探讨人乳头瘤病毒(HPV)自取样子宫颈癌筛查与医取样的一致性及其作为子宫颈癌筛查方法的可行性。方法选取参与子宫颈癌筛查的30~59岁女性2033名,分别进行HPV自取样和医取样,所收集标本进行Cobas 4800 HPV检测和第二代基因测序(Seq)HPV检测。任一HPV阳性者转诊阴道镜及宫颈活检,最终结果以组织病理学为金标准,分析自取样与医取样HPV阳性率一致性及检出子宫颈上皮内瘤变(CIN)2及以上病变(CIN2+)和CIN3+的准确性。结果①2033名女性中,任一HPV阳性者249例(12.2%),CIN2+29例(1.4%),CIN3+13例(0.6%)。Cobas-医取样与自取样、Seq-医取样与自取样对CIN2+检出率均为1.4%(28/2033);CIN3+检出率均为0.6%(13/2033),自取样与医取样检出率均具有较高一致性(Cobas-医取样与自取样Kappa=0.84;Seq-医取样与自取样Kappa=0.87)。②Cobas-医取样检出CIN2+的灵敏度(96.6%)与Cobas-自取样(96.6%)、Seq-医取样(96.6%)和Seq-自取样(100%)比较,差异均无统计学意义(P>0.05);Cobas-医取样检出CIN2+特异度(92.2%)与Seq-医取样(92.6%)、Seq-自取样(92.4%)比较,差异均无统计学意义(P>0.05),但与Cobas-自取样(90.9%)比较,差异有统计学意义(P<0.05);Cobas-医取样检出CIN2+的阴性预测值(99.9%)与Cobas-自取样(99.9%)、Seq-医取样(99.9%)和Seq-自取样(100%)比较,差异均无统计学意义(P>0.05)。③4种检测方法检出CIN3+的灵敏度均为100%,差异无统计学意义(P>0.05);Cobas-医取样检出CIN3+特异度(91.5%)与Seq-医取样(91.9%)、Seq-自取样(91.7%)比较,差异均无统计学意义(P>0.05),但与Cobas-自取样(90.2%)比较,差异有统计学意义(P<0.05);Cobas-医取样检出CIN3+的阴性预测值(100%)与Cobas-自取样(100%)、Seq-医取样(100%)和Seq-自取样(100%)比较,差异均无统计学意义(P>0.05)。结论HPV自取样与医取样对CIN2+和CIN3+的检出率和灵敏度相似,可用于子宫颈癌的人群筛查;Seq HPV与Cobas 4800 HPV检测具有相似的灵敏度和阴性预测值,可用于HPV自取样标本的检测。

Objective To compare the consistency and feasibility of self-sampling for human papillomavirus(HPV)with physician-sampling as a method for cervical cancer screening.Methods 2033 women aged 30 to 59 who involved in cervical cancer screening were selected for HPV self-sampling and physician-sampling,respectively,the collected specimens were tested for Cobas 4800 HPV and Seq HPV test.Any HPV positive was referred to colposcopy and cervical biopsy.The consistency of HPV positivity rates between self-sampling and physician-sampling,as well as the accuracy in detecting cervical intraepithelial neoplasia(CIN)2 or higher lesions(CIN2+)and CIN3+,were analyzed using histopathology as the gold standard.Results①Among the 2033 women,249 cases(12.2%)were high-risk HPV positive of any type,There were 29 cases(1.4%)of histopathological CIN2+and 13 cases(0.6%)of CIN3+.The detection rates for CIN2+were consistent between Cobasphysician-sampling and self-sampling(28/2033,1.4%)as well as Seq-physician-sampling and self-sampling(Kappa=0.84).The detection rates for CIN3+were also consistent between Cobas-physician-sampling and self-sampling(13/2033,0.6%)as well as Seq-physician-sampling and self-sampling(Kappa=0.87).②The sensitivity for detecting CIN2+was similar among Cobas-physician-sampling(96.6%),Cobas-self-sampling(96.6%),Seq-physician-sampling(96.6%),and Seq-self-sampling(100%)(P>0.05).The specificity for detecting CIN2+was not significantly different between Cobas-physician-sampling(92.2%),Seq-physician-sampling(92.6%),and Seq-self-sampling(92.4%)(P>0.05),but Cobas-self-sampling(90.9%)showed statistical significance(P<0.05).The negative predictive value(NPV)for detecting CIN2+was not significantly different among Cobas-physician-sampling(99.9%),Cobas-self-sampling(99.9%),Seq-physician-sampling(99.9%),and Seq-self-sampling(100%)(P>0.05).③The sensitivity for detecting CIN3+was 100%for all four methods,with no statistically significant differences(P>0.05).The specificity for detecting CIN3+was not significantly different between Cobas-physician-sampling(91.5%),Seq-physician-sampling(91.9%),and Seq-self-sampling(91.7%)(P>0.05),but Cobas-self-sampling(90.2%)showed statistical significance(P<0.05).The NPV for detecting CIN3+was not significantly different among Cobas-physician-sampling(100%),Cobas-self-sampling(100%),Seq-physician-sampling(100%),and Seq-self-sampling(100%)(P>0.05).Conclusions HPV self-sampling demonstrated similar detection rates and sensitivity for detecting high-grade cervical lesions compared to physician-sampling,making it a viable option for population-based cervical cancer screening.The Seq HPV test showed similar sensitivity and NPV to the Cobas 4800 HPV test and can be used for HPV self-sampling.