Laboratoire Alphabio, Marseille, France.
J Clin Virol. 2010 Feb;47(2):177-81. doi: 10.1016/j.jcv.2009.11.011. Epub 2009 Dec 22.
DNA- and mRNA-based assays are the main tools used for detecting human papillomavirus (HPV) nucleic acid in clinical samples. A recent tool, NucliSENS EasyQ HPV, uses a new concept to directly detect the expression of HPV oncogenic factors (E6 and E7) from the most prevalent HPV genotypes in cervical cancer (16, 18, 31, 33 and 45).
The primary aim of the study is to assess the accuracy of NucliSENS EasyQ HPV in detecting high-risk (HR) HPV in a population of atypical cells of undetermined significance/low-grade squamous intraepithelial lesion/high-grade squamous lesion (ASCUS/LSIL/HSIL) patients using a clinical cut-off of a cervical dysplasia (CIN2+) histology. The secondary aim is to compare this mRNA-based assay with the DNA-based hybrid capture II (HCII) assay.
The study population comprised 140 women referred for colposcopy and histology. NucliSENS EasyQ HPV test, hybrid capture II (HCII) test and linear array (LA) test were assessed on all samples. All the tests were performed on the samples collected in PreservCyt liquid media for liquid-based cytology (ThinPrep Pap test).
The clinical specificity of the NucliSENS EasyQ HPV was 63% for the detection of CIN2+ or HSIL patients, significantly higher than the specificity of HCII and LA (49% and 45%, respectively, p<0.05). Agreement between HCII and NucliSENS EasyQ HPV was fair (k=0.49) and was good between HCII and LA (k=0.88). HPV 16 was the most-detected type (49% with NucliSENS EasyQ HPV and 56% with LA), and HPV 31 was the second most-detected HPV type (31% with NucliSENS EasyQ HPV and 29% with LA).
The NucliSENS EasyQ HPV assay has interesting clinical sensitivity and specificity for the detection of HPV types in CIN2+ patients and shows comparable diagnostic values with the HCII DNA assay. This assay allows simultaneous detection of HPV mRNA and determination of the type of the main prevalent oncogenic virus.
DNA 和 mRNA 检测是用于检测临床样本中人类乳头瘤病毒（HPV）核酸的主要工具。最近出现的一种工具，即 NucliSENS EasyQ HPV，采用了一种新的概念，可直接检测宫颈癌中最常见 HPV 基因型（16、18、31、33 和 45）的 HPV 致癌因子（E6 和 E7）的表达。
本研究的主要目的是评估 NucliSENS EasyQ HPV 在使用宫颈癌前病变（CIN2+）组织学的临床截止值（ASCUS/LSIL/HSIL 患者的高危型（HR）HPV 检测中的准确性。次要目的是比较这种基于 mRNA 的检测方法与基于 DNA 的杂交捕获 II（HCII）检测方法。
研究人群包括 140 名因阴道镜检查和组织学而转诊的女性。对所有样本进行 NucliSENS EasyQ HPV 检测、杂交捕获 II（HCII）检测和线性阵列（LA）检测。所有测试均在 PreservCyt 液体培养基上采集的样本上进行，用于液体细胞学（ThinPrep Pap 测试）。
NucliSENS EasyQ HPV 检测对 CIN2+或 HSIL 患者的临床特异性为 63%，明显高于 HCII 和 LA 的特异性（分别为 49%和 45%，p<0.05）。HCII 和 NucliSENS EasyQ HPV 之间的一致性为中度（k=0.49），HCII 和 LA 之间的一致性为良好（k=0.88）。HPV 16 是最常见的检测类型（NucliSENS EasyQ HPV 检测 49%，LA 检测 56%），HPV 31 是第二常见的 HPV 类型（NucliSENS EasyQ HPV 检测 31%，LA 检测 29%）。
NucliSENS EasyQ HPV 检测方法对 CIN2+患者 HPV 类型的检测具有有趣的临床敏感性和特异性，并与 HCII DNA 检测方法具有可比的诊断价值。该检测方法可同时检测 HPV mRNA，并确定主要流行致癌病毒的类型。
