Department of Pathology, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region, China.
J Clin Microbiol. 2012 May;50(5):1691-7. doi: 10.1128/JCM.05933-11. Epub 2012 Feb 15.
High-risk human papillomavirus (HR-HPV) DNA detection in cervical cytology samples is useful for primary screening of cervical cancer and for triage of patients with equivocal cytological findings. The GenoFlow HPV array test (GF assay; Diagcor Bioscience Inc., Hong Kong) was recently developed to detect 33 HPV genotypes by a "flowthrough" hybridization technology. In this study, we assessed the analytical sensitivity and reproducibility of the GF assay and compared its genotyping results with those of the Linear Array (LA) assay (Roche Molecular Diagnostics, Indianapolis, IN), using 400 archived liquid-based cytology samples representing the full range of cytology findings. Genotyping findings of the GF and LA assays were concordant or compatible for 93.44% of tested samples, with a good (κ = 0.797) to very good (κ = 0.812) strength of agreement for assay-common and oncogenic HPV types, respectively. The two assays showed good (κ = 0.635) agreement in detecting infections with multiple HPV genotypes. The lowest detection limits of the GF assay for HPV16 and HPV18 were 25 copies and 20 copies, respectively. Repeat testing of 60 samples by use of two different lots of the GF assay revealed no discordant results, suggesting good reproducibility of the assay. Both assays achieved approximately 80% and 100% sensitivity for identifying cases of atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesions (LSIL) with subsequent detection of LSIL+ and high-grade squamous intraepithelial lesions or higher (HSIL+) in 2 years, respectively. Among ASC-US samples, the GF assay achieved the highest specificity (23.08%) for indicating subsequent identification of HSIL compared with the LA (19.23%) and Hybrid Capture 2 (HC2) (8.97%) assays. The GF and LA assays showed significant discrepancy in detecting HPV genotypes 11, 26, 39, 52, and 66. More sensitive detection of HPV52 by GF assay offers an advantage in regions where HPV52 is more prevalent. The sensitivity of the GF assay for detecting patients with HSIL+ was noninferior to that of the LA assay.
高危型人乳头瘤病毒（HR-HPV）DNA 检测在宫颈细胞学样本中用于宫颈癌的初步筛查和对具有不确定细胞学结果的患者进行分流。GenoFlow HPV 阵列检测（GF 检测；Diagcor Bioscience Inc.，香港）最近通过“流通过程”杂交技术开发，用于检测 33 种 HPV 基因型。在这项研究中，我们评估了 GF 检测的分析灵敏度和重现性，并比较了其基因分型结果与 Linear Array（LA）检测（罗氏分子诊断公司，印第安纳波利斯，IN）的结果，使用 400 个存档的液体基细胞学样本代表了全范围的细胞学发现。GF 和 LA 检测的基因分型结果在 93.44%的测试样本中是一致或兼容的，对于共同和致癌 HPV 类型，分别具有良好（κ=0.797）至非常好（κ=0.812）的一致性强度。两种检测方法在检测多种 HPV 基因型感染方面具有良好的（κ=0.635）一致性。GF 检测对 HPV16 和 HPV18 的最低检测限分别为 25 拷贝和 20 拷贝。使用 GF 检测的两个不同批次对 60 个样本进行重复检测，结果没有不一致，表明该检测具有良好的重现性。两种检测方法在识别非典型鳞状细胞意义不明确（ASC-US）和低度鳞状上皮内病变（LSIL）病例方面的灵敏度分别约为 80%和 100%，随后在 2 年内检测到 LSIL+和高级别鳞状上皮内病变或更高（HSIL+）。在 ASC-US 样本中，与 LA（19.23%）和 Hybrid Capture 2（HC2）（8.97%）检测相比，GF 检测对随后确定 HSIL 的指示具有最高的特异性（23.08%）。GF 和 LA 检测在检测 HPV 基因型 11、26、39、52 和 66 方面存在显著差异。GF 检测对 HPV52 的更敏感检测在 HPV52 更为流行的地区具有优势。GF 检测对 HSIL+患者的检测灵敏度不劣于 LA 检测。
