作　　者： ; ; ;

机构地区： 中国医学科学院北京协和医学院公共卫生学院

出　　处： 《癌症进展》 2019年第10期1160-1163,1177,共5页

摘　　要： 目的比较人乳头瘤病毒(HPV)E6/E7 mRNA和HPV DNA检测技术对宫颈上皮内瘤变(CIN)2级及以上(CIN2+)患者的诊断价值,并评价HPV E6/E7 mRNA检测结果在不同实验室间的一致性。方法采用HPV E6/E7 mRNA和HPV DNA检测技术对212例门诊体检的健康者和住院的宫颈病变患者的宫颈脱落细胞学标本进行检测。以病理诊断结果为金标准,评价两种检测技术诊断CIN2+的灵敏度和特异度。北京市迪安中心实验室和北京市怀柔妇幼保健院实验室均采用HPV E6/E7 m RNA检测技术检测同一批标本,评价实验室间检测的一致性。结果HPV E6/E7 m RNA检测的阳性率为38.7%,与HPV DNA的阳性率43.9%比较,差异无统计学意义(P﹥0.05)。HPV E6/E7 mRNA和HPV DNA的检测阳性率均随着病理分级的升高而增加(P<0.01)。HPV E6/E7mRNA检测CIN2+的灵敏度为92.96%,与HPV DNA的90.14%相比,差异无统计学意义(P﹥0.05),而HPV E6/E7mRNA检测CIN2+的特异度为88.65%,高于HPV DNA的79.43%,差异有统计学意义(P<0.05)。两个实验室采用HPV E6/E7 m RNA检测阳性一致的标本例数为78,阴性一致的标本例数为121,总一致率为93.87%,Kappa=0.872,一致性较好。结论与HPV DNA检测技术相比,HPV E6/E7 mRNA检测宫颈病变的特异度更具优势,实验室间重复性检测的一致率较高,有望成为中国宫颈癌HPV筛查的首选方法。 Objective To compare the diagnostic value of human papilloma virus(HPV)E6/E7 mRNA and HPV DNA detection technology in patients with cervical intraepithelial neoplasia(CIN)grade 2 or worse(CIN2+),and the consistency of HPV E6/E7 mRNA detection results in different laboratories.Method HPV E6/E7 mRNA and HPV DNA detection technology were used to detect cervical exfoliated cytological specimens from 212 cases of hospitalized patients with cervical lesions and health checkup in outpatient departments.The sensitivity and specificity of the two methods for CIN2+diagnosis were evaluated with pathological diagnosis as the gold standard.The laboratory of Beijing Di’an and Beijing Huairou Maternal and Child Health Hospital,used HPV E6/E7 mRNA detection technology to detect the same batch of samples and evaluated the consistency of the tests.Result The positive rate of HPV E6/E7 mRNA detection was 38.7%,which was not statistically different from the positive rate of HPV DNA as 43.9%(P>0.05).The positive rate of HPV E6/E7 mRNA and HPV DNA detection increased as the pathological grading raised(P<0.01).The sensitivity of HPV E6/E7 mRNA in detecting CIN2+was 92.96%,which was not statistically different compared with the 90.14%when using HPV DNA(P>0.05).The specificity of CIN2+detected by HPV E6/E7 mRNA was 88.65%,and it was higher than the 79.43%by HPV DNA,and the difference was statistically significant(P<0.05).The laboratories had the consistent results through HPV E6/E7 mRNA for 78 cases of positive samples and 121 cases of consistent negative samples,with an overall consistency rate of 93.87%and Kappa=0.872,showing a good consistency.Conclusion Compared with HPV DNA detection,HPV E6/E7 mRNA has higher specificity,and also better inter-lab consistency results,which may be a promising preferred option for HPV screening method in China.

关 键 词： 人乳头瘤病毒 宫颈上皮内瘤变

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