细胞周期蛋白 A1 启动子甲基化的自我采样检测。
CyclinA1 Promoter Methylation in Self-Sampling Test.
机构信息
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Panyananthaphikkhu Chonprathan Medical Center, Srinakharinwirot University, Nonthaburi, Thailand.
出版信息
Asian Pac J Cancer Prev. 2020 Oct 1;21(10):2913-2917. doi: 10.31557/APJCP.2020.21.10.2913.
BACKGROUND
Self sampled HPV testing is a cervical cancer screening method . However, cytology in self-sampled specimen cannot be used as a triage test. Therefore, other methods for triage should be considered. CyclinA1 (CCNA1) promoter methylation has strong association with cervical precancerous and cancerous lesion. The objective of this study was to compare the diagnostic value of CCNA1 and self-sampled specimen for detecting high-grade cervical intraepithelial lesions or worse (CIN2+).
MATERIALS AND METHODS
A cross sectional study was conducted. Women with abnormal cytology or positive for high risk HPV (hrHPV) indicated for colposcopic examination were enrolled. Self-collected sampling for hrHPV DNA (SS-HPV) and CCNA1 were performed. hrHPV DNA testing was done by Cobas 4800 method. CCNA1 promoter methylation was detected by CCNA1 duplex methylation specific PCR. Histopathologic result as CIN2+ obtaining from colposcopic directed biopsy or excisional procedure was considered as positive a gold standard. The results of hrHPV and CCNA1 were reported as positive or negative. Sensitivity specificity, positive predictive value, and negative predictive value of SS-HPV and CCNA1 were calculated by comparing the results with the gold standard.
RESULTS
Two hundreds and eighty women were recruited. High-grade cervical lesions and cervical cancer (CIN2+) were diagnosed in 21.8% (61 cases) of the patients. The most common type of hrHPV was non 16, 18 subtype, followed by HPV16 and 18. CCNA1 was positive in 13 patients out of whom, twelve were CIN2+. Sensitivity of CCNA1 was 19.7 % and its specificity and accuracy were 99.5% and 82.14%, respectively. The sensitivity of SS-HPV was 70.5%, and its specificity and accuracy were 39.2% and 43.3%, respectively.
CONCLUSION
Due to high specificity and positive predictive value of CCNA1, it can be used as alarming sign of having high-grade cervical intraepithelial lesions, especially in patient who has positive hrHPV DNA test based on self-collected sampling.
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背景
自我采样 HPV 检测是一种宫颈癌筛查方法。然而，自我采样标本中的细胞学检查不能作为分流试验。因此，应考虑其他分流方法。CyclinA1（CCNA1）启动子甲基化与宫颈癌前病变和癌前病变有很强的关联。本研究的目的是比较 CCNA1 和自我采样标本检测高级别宫颈上皮内瘤变或更差（CIN2+）的诊断价值。
材料和方法
进行了一项横断面研究。细胞学异常或高危型 HPV（hrHPV）阳性的女性，提示行阴道镜检查，入组后行自我采样检测 hrHPV DNA（SS-HPV）和 CCNA1。hrHPV DNA 检测采用 Cobas 4800 方法。CCNA1 启动子甲基化采用 CCNA1 双甲基化特异性 PCR 检测。阴道镜指导下活检或切除的组织学结果为 CIN2+，作为金标准。将 hrHPV 和 CCNA1 的结果报告为阳性或阴性。通过与金标准比较，计算 SS-HPV 和 CCNA1 的敏感性、特异性、阳性预测值和阴性预测值。
结果
共入组 280 例女性。21.8%（61 例）患者诊断为高级别宫颈病变和宫颈癌（CIN2+）。最常见的 hrHPV 类型是非 16、18 亚型，其次是 HPV16 和 18。13 例患者 CCNA1 阳性，其中 12 例为 CIN2+。CCNA1 的敏感性为 19.7%，特异性和准确性分别为 99.5%和 82.14%。SS-HPV 的敏感性为 70.5%，特异性和准确性分别为 39.2%和 43.3%。
结论
由于 CCNA1 具有较高的特异性和阳性预测值，因此可以作为高级别宫颈上皮内瘤变的预警信号，尤其是在基于自我采样检测出 hrHPV DNA 阳性的患者中。
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