WHO Human Papillomavirus Laboratory Network Global Reference Laboratory, Chronic Viral Diseases Branch, Division of High-Consequence Pathogens, and National Center for Emerging and Zoonotic Infectious Diseases Pathology, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
J Clin Microbiol. 2012 May;50(5):1539-44. doi: 10.1128/JCM.06576-11. Epub 2012 Feb 22.
The performance of three line blot assays (LBAs), the Linear Array HPV genotyping assay (LA) (Roche Diagnostics), INNO-LiPA HPV Genotyping Extra (LiPA) (Innogenetics), and the reverse hybridization assay (RH) (Qiagen), was evaluated using quantitated whole genomic human papillomavirus (HPV) plasmids (types 6, 11, 16, 18, 31, 33, 35, 39, 51, 52, 56, 58, 59, and 68b) as well as epidemiologic samples. In a plasmid titration series, LiPA and RH did not detect 50 international units (IU) of HPV type 18 (HPV18) in the presence of 5 × 10(4) IU or more of HPV16. HPV DNA (1 to 6 types) in the plasmid challenges at 50 IU or genome equivalents (GE) were identified with an accuracy of 99.9% by LA, 97.3% by LiPA, and 95.4% by RH, with positive reproducibility of 99.8% (kappa = 0.992), 88.2% (kappa = 0.928), and 88.1% (kappa = 0.926), respectively. Two instances of mistyping occurred with LiPA. Of the 120 epidemiologic samples, 76 were positive for high-risk types by LA, 90 by LiPA, and 69 by RH, with a positive reproducibility of 87.3% (kappa = 0.925), 83.9% (kappa = 0.899), and 90.2% (kappa = 0.942), respectively. Although the assays had good concordance in the clinical samples, the greater accuracy and specificity in the plasmid panel suggest that LA has an advantage for internationally comparable genotyping studies.
三种线印迹分析（LBA）、线性阵列 HPV 基因分型分析（LA）（罗氏诊断）、INNO-LiPA HPV 基因分型额外分析（LiPA）（Innogenetics）和反向杂交分析（RH）（Qiagen）的性能使用定量全基因组人乳头瘤病毒（HPV）质粒（类型 6、11、16、18、31、33、35、39、51、52、56、58、59 和 68b）以及流行病学样本进行了评估。在质粒滴定系列中，LiPA 和 RH 在存在 5×10(4)IU 或更多 HPV16 的情况下，无法检测到 50 国际单位（IU）的 HPV18（HPV18）。LA 以 99.9%的准确性、LiPA 以 97.3%的准确性和 RH 以 95.4%的准确性识别质粒挑战中 50IU 或基因组当量（GE）的 HPV DNA（1 至 6 型），阳性重现性分别为 99.8%（kappa = 0.992）、88.2%（kappa = 0.928）和 88.1%（kappa = 0.926）。LiPA 出现了两次误判。在 120 个流行病学样本中，76 个样本经 LA 检测为高危型阳性，90 个样本经 LiPA 检测为高危型阳性，69 个样本经 RH 检测为高危型阳性，阳性重现性分别为 87.3%（kappa = 0.925）、83.9%（kappa = 0.899）和 90.2%（kappa = 0.942）。虽然这些检测方法在临床样本中具有良好的一致性，但质粒组的更高准确性和特异性表明 LA 具有进行国际可比基因分型研究的优势。
