透景HPV检测试剂在高危HPV DNA检测及宫颈上皮内瘤变筛查中的应用  

Evaluation of Tellgen test kit in high-risk HPV DNA detection and cervical intraepithelial neoplasia screening

作　　者：吴泽妮 秦宇[2] 李婷媛[1] 姜明月[1] 刘彬[1] 于露露[1] 王红[1] 崔剑峰[1] 陈汶[1] 

机构地区：[1]北京协和医学院/中国医学科学院肿瘤医院流行病学研究室,北京100021 [2]大连医科大学公共卫生学院流行病与卫生统计学教研室,辽宁大连116044

出　　处：《临床检验杂志》2016年第2期90-94,共5页Chinese Journal of Clinical Laboratory Science

摘　　要：目的评价国产透景试剂(透景HPV)用于HR-HPV DNA检测及宫颈病变诊断的有效性和可行性。方法 602例来自医院门诊健康体检的妇女或者宫颈上皮内瘤变(CIN)住院治疗的患者,经病理学明确诊断。采用透景试剂和Roche试剂(cobas HPV)平行检测子宫颈脱落细胞标本,比较两种方法的一致性。以病理诊断结果作为金标准,评估透景试剂和Roche试剂筛查子宫颈上皮内瘤变的敏感性和特异性。结果透景试剂与Roche试剂总一致率为94.62%(Kappa=0.881),阳性一致率为96.85%,阴性一致率为90.53%;透景试剂与Roche试剂HPV16、HPV18及其他12种高危型HPV的总一致率分别为95.92%(Kappa=0.906),98.70%(Kappa=0.885)和92.76%(Kappa=0.805)。校正后两种检测的总一致率为98.51%(Kappa=0.967),阳性一致率为98.87%,阴性一致率为97.81%;校正后HPV16,HPV18及其他12种高危型HPV的总一致率分别为97.40%(Kappa=0.940),100%(Kappa=1.00)和97.58%(Kappa=0.950)。透景试剂筛查CIN2+的敏感性和特异性分别为91.52%和52.06%,Roche试剂筛查CIN2+的敏感性和特异性分别为91.52%和54.29%,无统计学差异(P>0.05)。结论国产透景试剂与进口Roche试剂检测HR-HPV的一致性高,是有效的HPV DNA检测方法,可用于人群中宫颈癌和癌前病变的筛查。Objective To evaluate the feasibility and reliability of Tellgen test kit in high-risk human papillomavirus（ HR-HPV） DNA detection and cervical intraepithelial neoplasia screening. Methods A total of 602 specimens of cervical exfoliated cells from colposcopy were collected from outpatients of clinics or inpatients for cervical intraepithelial neoplasia（ CIN） treatment. All the specimen were diagnosed by pathological examination. The agreement between Tellgen and Roche cobas HPV test kit was assessed. Pathohistological diagnosis was considered as gold standard to compare the sensitivity and specificity of Tellgen and cobas kit in detection of CIN.Results The total concordance rate of Tellgen kit with cobas kit was 94. 62%（ Kappa = 0. 881）,in which the positive concordance rate was 96. 85% and the negative concordance rate was 90. 53%. The total concordance rate of the two test kit for HPV16,HPV18 and other 12 types of high-risk HPV were 95. 92%（ Kappa = 0. 906）,98. 70%（ Kappa = 0. 885） and 92. 76%（ Kappa = 0. 805）,respectively. After calibration by PCR-SSP as reference method,the total concordance rate of the two tests was 92. 76%（ Kappa =0. 967）,in which the positive concordance rate was 98. 87% and the negative concordance rate was 97. 81%. After calibration the total concordance rate of HPV16,HPV18 and other 12 types of high-risk HPV were 97. 40%（ Kappa = 0. 940）,100%（ Kappa = 1. 00）and 97. 58%（ Kappa = 0. 950）,respectively. For the detection of CIN,the sensitivity and specificity were 91. 52% and 52. 06% for Tellgen kit,and 91. 52% and 54. 29% for cobas kit without significant difference between the results of the two kids（ P〉0. 05）.Conclusion The results of HR-HPV detected by China-made Tellgen test kit showed high acordance with those of Roche cobas HPV test,so Tellgen kit should be reliable for HPV DNA detection and cervical cancer screening.

关 键 词：人乳头瘤病毒(HPV) 实时荧光定量PCR 宫颈上皮内瘤变(CIN) 

分 类 号：R446[医药卫生—诊断学]