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福建省中国女性宫颈病变中PCR反向斑点杂交人乳头瘤病毒基因分型检测的临床验证:一项基于医院的人群研究

Clinical validation of the PCR-reverse dot blot human papillomavirus genotyping test in cervical lesions from Chinese women in the Fujian province: a hospital-based population study.

作者信息

Sun Pengming, Song Yiyi, Ruan Guanyu, Mao Xiaodan, Kang Yafang, Dong Binhua, Lin Fen

机构信息

Laboratory of Gynecologic Oncology, Fujian Provincial Maternity & Children's Health Hospital of Fujian Medical University, Fuzhou, China.

Department of Gynecology, Fujian Provincial Maternity & Children's Health Hospital of Fujian Medical University, Fuzhou, China.

出版信息

J Gynecol Oncol. 2017 Sep;28(5):e50. doi: 10.3802/jgo.2017.28.e50. Epub 2017 Apr 25.

DOI:10.3802/jgo.2017.28.e50
PMID:28657218
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5540716/
Abstract

OBJECTIVE

To determine the clinical significance of the polymerase chain reaction (PCR)-reverse dot blot (RDB) human papillomavirus (HPV) genotyping assay in cervical cancer screening.

METHODS

A total of 10,442 women attending the Fujian Provincial Maternity and Children's Health Hospital were evaluated using the liquid-based cytology (thinprep cytologic test [TCT]) and the PCR-RDB HPV test. Women with HPV infection and/or abnormal cytology were referred for colposcopy and biopsy. For HPV DNA sequencing, 120 specimens were randomly selected. Pathological diagnosis was used as the gold standard.

RESULTS

Using the PCR-RDB HPV test, overall HPV prevalence was 20.57% (2,148/10,442) and that of high-risk (HR)-HPV infection was 18.68% (1,951/10,442). There was 99.2% concordance between HPV PCR-RDB testing and sequencing. In this studied population, the most common HR-HPV types were HPV-16, -52, -58, -18, -53, -33, and -51, rank from high to low. HPV-16, -18, -58, -59, and -33 were the top 5 prevalent genotypes in cervical cancer but HPV-16, -18, -59, -45, and -33 were the top 5 highest risk factors for cancer (odds ratio [OR]=34.964, 7.278, 6.728, 6.101, and 3.658; all p<0.05, respectively). Among 10,442 cases, 1,278 had abnormal cytology results, of which, the HR-HPV positivity rate was 83.02% (1,061/1,278). To screen for cervical cancer by PCR-RDB HPV testing, when using CIN2+, CIN3+, and cancer as observed endpoints, the sensitivity was 90.43%, 92.61%, and 94.78% and the negative predictive value (NPV) was 99.06%, 99.42%, and 99.78%, respectively. PCR-RDB HPV and TCT co-testing achieved the highest sensitivity and NPV.

CONCLUSION

For cervical cancer screening, the PCR-RDB HPV test can provide a reliable and sensitive clinical reference.

摘要

目的

确定聚合酶链反应(PCR)-反向点杂交(RDB)人乳头瘤病毒(HPV)基因分型检测在宫颈癌筛查中的临床意义。

方法

对福建省妇幼保健院的10442名女性进行了液基细胞学检查(薄层液基细胞学检测[TCT])和PCR-RDB HPV检测。HPV感染和/或细胞学异常的女性被转诊进行阴道镜检查和活检。随机选择120份标本进行HPV DNA测序。病理诊断作为金标准。

结果

采用PCR-RDB HPV检测,总体HPV感染率为20.57%(2148/10442),高危(HR)-HPV感染率为18.68%(1951/10442)。HPV PCR-RDB检测与测序的一致性为99.2%。在该研究人群中,最常见的HR-HPV类型依次为HPV-16、-52、-58、-18、-53、-33和-51。HPV-16、-18、-58、-59和-33是宫颈癌中最常见的5种基因型,但HPV-16、-18、-59、-45和-33是癌症的前5大高危因素(比值比[OR]=34.964、7.278、6.728、6.101和3.658;均P<0.05)。在10442例病例中,1278例细胞学检查结果异常,其中HR-HPV阳性率为83.02%(1061/1278)。以PCR-RDB HPV检测筛查宫颈癌,以CIN2+、CIN3+和癌症为观察终点时,灵敏度分别为90.43%、92.61%和94.78%,阴性预测值(NPV)分别为99.06%、99.42%和99.78%。PCR-RDB HPV与TCT联合检测具有最高的灵敏度和NPV。

结论

对于宫颈癌筛查,PCR-RDB HPV检测可提供可靠且灵敏的临床参考。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c62/5540716/fa58ebdc5268/jgo-28-e50-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c62/5540716/b57d9917e5b2/jgo-28-e50-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c62/5540716/b466ed091237/jgo-28-e50-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c62/5540716/fa58ebdc5268/jgo-28-e50-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c62/5540716/b57d9917e5b2/jgo-28-e50-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c62/5540716/b466ed091237/jgo-28-e50-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c62/5540716/fa58ebdc5268/jgo-28-e50-g003.jpg

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