Hôpital Ambroise Paré, Marseille, France.
J Clin Virol. 2010 Jan;47(1):38-42. doi: 10.1016/j.jcv.2009.10.013. Epub 2009 Nov 25.
HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 66 are considered carcinogenic for human beings. DNA-chip technology, Papillocheck HPV-screening (Greiner) and reverse dot blot, Linear Array (LA) (Roche) are tools to assess the distribution of HPV genotypes.
The aim of the study was to compare the clinical performance of Papillocheck and LA assays using a clinical cut-off of CIN2+. The secondary aim was to comparatively assess the distribution of HPV types using these two assays.
The study population comprised 239 women referred for colposcopy and histology. Papillocheck, LA, and Hybrid Capture II (HCII) tests were done on all samples.
All tests showed good sensitivity and NPV (greater than 90%). None of the comparisons of sensitivities, specificities, PPVs, and NPVs showed statistically relevant differences between tests. High-risk HPV positivity rate was similar for all tests (Papillocheck 75%, LA 77%, and HCII 73%). Agreement between tests was good. The concordance levels between HCII and Papillocheck and between HCII and LA were 93% (k=0.82) and 92% (k=0.80), respectively. Papillocheck and LA tests showed a high overall concordance rate of 96% (k=0.90). HPV16 was the most detected type (45% with Papillocheck, and 47% with LA), and HPV31 was the second most detected type (13% with Papillocheck, and 14% with LA).
The Papillocheck HPV-screening test and LA test have a good clinical sensitivity to detect HPV types in CIN2+ patients. These assays allow, in the same experiment, to detect and determine the virus type. Our study showed that HPV types 16 and 31/33 are the most prevalent.
HPV 类型 16、18、31、33、35、39、45、51、52、56、58、59 和 66 被认为对人类具有致癌性。DNA 芯片技术、Papillocheck HPV 筛查（Greiner）和反向斑点印迹、线性阵列（LA）（罗氏）是评估 HPV 基因型分布的工具。
本研究旨在比较 Papillocheck 和 LA 检测方法在 CIN2+临床切点下的临床性能。次要目的是使用这两种检测方法比较 HPV 类型的分布。
研究人群包括 239 名因阴道镜和组织学检查而转介的女性。对所有样本进行 Papillocheck、LA 和杂交捕获 II（HCII）检测。
所有检测均显示出良好的敏感性和阴性预测值（均大于 90%）。三种检测方法的敏感性、特异性、阳性预测值和阴性预测值之间的比较均无统计学差异。所有检测方法的高危 HPV 阳性率相似（Papillocheck 75%、LA 77%和 HCII 73%）。检测之间的一致性良好。HCII 与 Papillocheck 之间以及 HCII 与 LA 之间的一致性水平分别为 93%（k=0.82）和 92%（k=0.80）。Papillocheck 和 LA 检测方法的总体一致性率为 96%（k=0.90）。HPV16 是检测到的最常见类型（Papillocheck 检测到 45%，LA 检测到 47%），HPV31 是第二常见的类型（Papillocheck 检测到 13%，LA 检测到 14%）。
Papillocheck HPV 筛查试验和 LA 试验具有良好的临床敏感性，可检测 CIN2+患者的 HPV 类型。这些检测方法允许在同一实验中同时检测和确定病毒类型。我们的研究表明，HPV 类型 16 和 31/33 是最常见的类型。
