摘要
目的验证careHPV^(TM)检测作为宫颈癌及癌前病变初筛方法的可靠性和有效性。方法在山西省襄垣县的459例受检者中行careHPV^(TM)与第二代杂交捕获(hc2)、HPV PCR检测方法的平行比较,评价careHPV^(TM)作为初筛方法检出宫颈高度以上病变(≥CIN 2)的灵敏度和特异度。结果 careHPV^(TM)与hc2的Kappa值为0.815(P<0.0001),一致率为92.6%(95%CI:89.8%～94.7%);与HPV核酸扩增PCR荧光检测试剂盒的Kappa值为0.765(P<0.0001),一致率为90.3%(95%CI:87.3%～92.8%)。careHPV^(TM)检出≥CIN 2的灵敏度、特异度、阳性预测值和阴性预测值分别为90.9%(95%CI:81.0%～96.6%)、82.0%(95%CI:78.0%～85.6%)、41.7%(95%CI:33.1%～50.6%)和98.5%(95%CI:96.6%～99.4%)。结论 careHPV^(TM)与已被SFDA批准的hc2试剂、HPV PCR试剂具有高度一致性,可以作为一种有效的宫颈癌初筛方法在农村地区推广应用。
Objective To evaluate the validity and reliability of careHPVTM as a screening method for cervical caneer and precancerous lesions. Methods Three cervical cancer screening methods were compared： careHPVTM , Hybrid Capture 2 High-Risk HPV DNA Test （hc2） and HPV PCR, of which the sensitivity and specificity were evaluated for detec- ting high-grade cervical intraepithelial neoplasis （ ≥ CIN 2） among 459 women in Xiangyuan county of Shanxi province. Results Kappa value and the agreement rate between careHPVTM and hc2 were 0. 815 （P 〈 0. 0001 ） and 92. 6% （95% CI： 89. 8% -94. 7% ）, respectively; and those between careHPVTM and PCR fluorescence detection kit for human papil- lomavirus were 0. 765 （P 〈0. 0001 ） and 90. 3% （95% CI： 87.3% -92. 8% ）, respectively. The sensitivity, specifici- ty, positive predictive value and negative predictive values were 90. 9% （95%CI： 81.0% -96. 6% ）, 82. 0% （95%CI： 78. 0% -85.6% ） , 41.7% （95% CI： 33.1% -50. 6% ） and 98.5% （95% CI： 96. 6% -99.4% ）, respectively, for the careHPVTM for detection of CIN 2 ＋. Conclusion careHPVTM is highly consistent with hc2 and HPV PCR, which have been approved by SFDA. careHPVTM could be implemented as an effective screening method of cervical cancer in ru- ral areas.
出处
《癌症进展》
2012年第5期506-510,共5页
Oncology Progress
