人乳头瘤病毒致癌基因 mRNA 检测在 HIV 阳性男男性行为者肛门发育不良中的应用。
Human papillomavirus oncogene mRNA testing for the detection of anal dysplasia in HIV-positive men who have sex with men.
机构信息
Institute of Virology, National Reference Center for Papilloma- and Polyomaviruses, University of Cologne, Fuerst-Pueckler-Strasse 56, 50935 Koeln, Germany.
出版信息
J Clin Virol. 2012 Apr;53(4):325-31. doi: 10.1016/j.jcv.2011.12.029. Epub 2012 Jan 18.
BACKGROUND
Anal human papillomavirus (HPV) infection and anal dysplasia are frequent in HIV-positive men who have sex with men (HIV+MSM), and progression of low-grade (LSIL) to high-grade squamous intraepithelial lesions (HSIL) or anal cancer (AC) occurs faster than in HIV-negative individuals. High-risk (HR)-HPV-E6/E7 oncogene mRNA testing has a higher specificity and a higher positive predictive value (PPV) than HR-HPV-DNA testing for detecting high-grade cervical lesions.
OBJECTIVE
To evaluate the diagnostic accuracy of the NucliSENS-EasyQ HPV1.1 E6/E7-mRNA-assay for the detection of anal dysplasia in HIV+MSM.
STUDY DESIGN
289 intraanal swabs from HIV+MSM participating in a screening program that included anal cytology, high-resolution anoscopy and histology were analyzed. HR-HPV-DNA detection was performed by PCR and hybridization using a bead-based multiplex genotyping assay. E6/E7-mRNA detection of HR-HPV-types 16, 18, 31, 33 and 45 was performed using the NucliSENS-EasyQ assay.
RESULTS
269 swabs had valid results in both test formats (111 normal, 10 ASCUS, 105 LSIL, 42 HSIL, 1 AC). For the detection of LSIL+(LSIL+HSIL+cancer) sensitivity, specificity, negative predictive value (NPV) and PPV were 80.4%, 26.4%, 52.5%, and 57.2% for HR-HPV-DNA testing, respectively, compared to 75.7%, 57.9%, 66.0% and 68.7% for E6/E7-mRNA testing. The respective values for the detection of HSIL/cancer were 95.3%, 26.1%, 96.7%, 19.7% for HR-HPV-DNA and 95.3%, 46.0%, 98.1%, 25.2% for E6/E7-mRNA detection.
CONCLUSION
Compared to HR-HPV-DNA detection, E6/E7-mRNA testing has an increased specificity (approximately two-fold), similar sensitivity and higher NPV and PPV for the detection of low- and high-grade anal dysplasia in HIV+MSM.
背景
人乳头瘤病毒（HPV）感染和肛门发育不良在 HIV 阳性男男性行为者（HIV+MSM）中很常见，低级别（LSIL）向高级别鳞状上皮内病变（HSIL）或肛门癌（AC）的进展速度比 HIV 阴性个体更快。高危型（HR）-HPV-E6/E7 致癌基因 mRNA 检测在检测高级别宫颈病变方面的特异性和阳性预测值（PPV）均高于 HR-HPV-DNA 检测。
目的
评估 NucliSENS-EasyQ HPV1.1 E6/E7-mRNA 检测法在 HIV+MSM 肛门发育不良中的诊断准确性。
研究设计
对参加筛查计划的 289 名 HIV+MSM 的肛内拭子进行分析，该计划包括肛门细胞学、高分辨率肛门镜检查和组织学检查。采用基于珠的多重基因分型检测方法通过 PCR 和杂交法检测 HR-HPV-DNA。使用 NucliSENS-EasyQ 检测法检测 HR-HPV 型 16、18、31、33 和 45 的 E6/E7-mRNA。
结果
269 个拭子在两种检测方法中均有有效结果（111 个正常、10 个 ASCUS、105 个 LSIL、42 个 HSIL、1 个 AC）。对于 LSIL+（LSIL+HSIL+癌）的检测，HR-HPV-DNA 检测的灵敏度、特异性、阴性预测值（NPV）和 PPV 分别为 80.4%、26.4%、52.5%和 57.2%，而 E6/E7-mRNA 检测分别为 75.7%、57.9%、66.0%和 68.7%。HR-HPV-DNA 检测 HSIL/癌的检测值分别为 95.3%、26.1%、96.7%、19.7%，E6/E7-mRNA 检测分别为 95.3%、46.0%、98.1%、25.2%。
结论
与 HR-HPV-DNA 检测相比，E6/E7-mRNA 检测对 HIV+MSM 中低级别和高级别肛门发育不良的检测具有更高的特异性（约两倍）、相似的灵敏度以及更高的 NPV 和 PPV。
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