基于 GP5+/6+-PCR 的反向点杂交检测法与 SPF10-PCR 线性探针杂交检测法检测人乳头瘤病毒基因分型的头对头比较。
Head-to-head comparison of genotyping of human papillomavirus by GP5+/6+-PCR-based reverse dot blot hybridization assay and SPF10-PCR-based line probe assay.
机构信息
School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
出版信息
J Med Virol. 2023 Feb;95(2):e28435. doi: 10.1002/jmv.28435.
The SPF10-PCR-based line probe assay (LiPA-25) for human papillomavirus (HPV) genotyping with high analytical sensitivity and specificity was widely used in HPV vaccine clinical trials and epidemiologic studies. In the study, we aimed to compare a novel GP5+/6+-PCR-based reverse dot blot hybridization assay (Yaneng-23) with LiPA-25. The performance of two assays was evaluated in 1735 cervical swab and 117 tissue samples, with a focus on 19 common HPV types (14 high-risk: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68/73; 5 low-risk: 6, 11, 42, 43, and 53). A total of 1197 (69.0%) swab samples were identified as HPV-positive by two assays. Of these, 878 (73.4%) samples displayed absolute agreement (concordant), 255 (21.3%) showed additional or fewer types (compatible), and the remaining 64 (5.3%) samples were discordant. Additionally, the two assays showed an excellent strength of agreement for 19 HPV-combined detection (κ = 0.886) and 17 individual HPV types (all κ > 0.800), and displayed a good agreement for HPV39 (κ = 0.780) and 42 (κ = 0.699). Yaneng-23 was more sensitive than LiPA-25 for HPV58, 59, 68/73, 42, 43 and 53 (McNemar's test: all p < 0.05), while LiPA-25 was more sensitive for HPV31, 39, 52, and 66 than Yaneng-23 (all p < 0.05). In 113 HPV-positive tissue specimens, the identification of genotypes was 82.3% identical and 17.7% compatible. The agreement between the tests for HPV45 (κ = 0.796) and 51 (κ = 0.742) was good, and for other types (all κ > 0.843) and 19 HPV-combined detection (κ = 0.929) was perfect (all p > 0.05). In conclusion, Yaneng-23 and LiPA-25 are comparable. Yaneng-23 could be used for the detection and genotyping of HPV in cervical samples for epidemiological and vaccine studies worldwide.
基于 SPF10-PCR 的线性探针分析（LiPA-25）用于人乳头瘤病毒（HPV）基因分型，具有高分析灵敏度和特异性，已广泛应用于 HPV 疫苗临床试验和流行病学研究。在本研究中，我们旨在比较一种新的基于 GP5+/6+-PCR 的反向斑点印迹杂交检测（Yaneng-23）与 LiPA-25。我们评估了两种检测方法在 1735 例宫颈拭子和 117 例组织样本中的性能，重点关注 19 种常见 HPV 类型（14 种高危型：16、18、31、33、35、39、45、51、52、56、58、59、66 和 68/73；5 种低危型：6、11、42、43 和 53）。两种检测方法共检测出 1197 例（69.0%）宫颈拭子 HPV 阳性。其中，878 例（73.4%）样本显示绝对一致（相符），255 例（21.3%）显示额外或更少的类型（兼容），64 例（5.3%）样本显示不一致。此外，两种检测方法对 19 种 HPV 联合检测（κ=0.886）和 17 种 HPV 单独检测（均κ>0.800）的一致性强度均较好，HPV39（κ=0.780）和 42（κ=0.699）的一致性也较好。Yaneng-23 对 HPV58、59、68/73、42、43 和 53 的检测敏感性均高于 LiPA-25（McNemar 检验：均 p<0.05），而 LiPA-25 对 HPV31、39、52 和 66 的检测敏感性均高于 Yaneng-23（均 p<0.05）。在 113 例 HPV 阳性组织标本中，基因型鉴定的一致性为 82.3%，兼容性为 17.7%。两种检测方法对 HPV45（κ=0.796）和 51（κ=0.742）的一致性较好，对其他类型（均κ>0.843）和 19 种 HPV 联合检测（κ=0.929）的一致性为极好（均 p>0.05）。总之，Yaneng-23 和 LiPA-25 具有可比性。Yaneng-23 可用于全球 HPV 流行病学和疫苗研究中宫颈样本的 HPV 检测和基因分型。
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