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人乳头瘤病毒(HPV)检测技术比较:杂交捕获2代、PreTect HPV检测试剂以及HPV16、HPV18和HPV33 E6/E7信使核糖核酸阳性样本中HPV DNA病毒载量分析

Comparison of HPV detection technologies: Hybrid capture 2, PreTect HPV-Proofer and analysis of HPV DNA viral load in HPV16, HPV18 and HPV33 E6/E7 mRNA positive specimens.

作者信息

Keegan Helen, Mc Inerney Jamie, Pilkington Loretto, Grønn Petter, Silva Ivan, Karlsen Frank, Bolger Noel, Logan Catriona, Furuberg Liv, O'Leary John, Martin Cara

机构信息

Department of Pathology, Coombe Women and Infants University Hospital, Dublin 8, Ireland.

出版信息

J Virol Methods. 2009 Jan;155(1):61-6. doi: 10.1016/j.jviromet.2008.09.027. Epub 2008 Nov 13.

DOI:10.1016/j.jviromet.2008.09.027
PMID:18955086
Abstract

Human papillomavirus (HPV) testing using molecular methods in liquid based cytology (LBC) specimens may be useful as an adjunct to cervical screening by cytology. We compared the positivity rate of the commercially available HPV DNA method hybrid capture 2 (hc2) and the commercially available E6/E7 mRNA method PreTect HPV-Proofer in cytological specimens (n=299). LBC specimens collected (n=299) represented the following cervical cytological disease categories: Normal (n=60), borderline nuclear abnormalities (BNA) (n=34), CIN1 (n=121), CIN2 (n=60), CIN3 (n=24). Overall, 69% (205/299) of the cases were positive by hc2 and 38% (112/299) of the cases were positive by PreTect HPV-Proofer. Concordance rates between the two tests were highest in the high-grade cytology cases (CIN2: 67% and CIN3: 83%) and the normal cytology cases (88%) and lowest in the BNA and CIN1 categories (56% and 52%). HPV DNA viral load analyses were carried out on HPV16 (n=55), HPV18 (n=9) and HPV33 (n=13) samples that were positive by PreTect HPV-Proofer. The sensitivity and specificity of PreTect HPV-Proofer and the hc2 DNA test for the detection of high-grade cytology (i.e. CIN2+) were 71.4% and 75.8% vs 100% and 43.7%, respectively. The relatively low detection rate observed by PreTect HPV-Proofer in the whole range of cytological positive cases, combined with a relatively higher specificity and PPV, suggests that PreTect HPV-Proofer may be more useful than hc2 for triage and in predicting high-grade disease.

摘要

在液基细胞学(LBC)标本中使用分子方法进行人乳头瘤病毒(HPV)检测,可能有助于作为细胞学宫颈筛查的辅助手段。我们比较了市售的HPV DNA方法杂交捕获2(hc2)和市售的E6/E7 mRNA方法PreTect HPV-Proofer在细胞学标本(n = 299)中的阳性率。收集的LBC标本(n = 299)代表以下宫颈细胞学疾病类别:正常(n = 60)、核边界异常(BNA)(n = 34)、CIN1(n = 121)、CIN2(n = 60)、CIN3(n = 24)。总体而言,hc2检测阳性的病例占69%(205/299),PreTect HPV-Proofer检测阳性的病例占38%(112/299)。两种检测方法之间的一致性率在高级别细胞学病例(CIN2:67%,CIN3:83%)和正常细胞学病例(88%)中最高,在BNA和CIN1类别中最低(56%和52%)。对PreTect HPV-Proofer检测呈阳性的HPV16(n = 55)、HPV18(n = 9)和HPV33(n = 13)样本进行了HPV DNA病毒载量分析。PreTect HPV-Proofer和hc2 DNA检测用于检测高级别细胞学(即CIN²+)的敏感性和特异性分别为71.4%和75.8%,而hc2为100%和43.7%。PreTect HPV-Proofer在整个细胞学阳性病例范围内观察到的相对较低的检测率,再加上相对较高的特异性和阳性预测值,表明PreTect HPV-Proofer在分流和预测高级别疾病方面可能比hc2更有用。

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