基于SPF10-PCR的线探针测定(LiPA-25)具有高的分析灵敏度和特异性,可用于临床样品中的HPV基因分型,已广泛用于疫苗和流行病学研究。最近已经开发了一种使用类型特异性引物(Hybribio-23)的实时多重PCR测定法,该测定法具有低工作量和成本。该研究旨在比较LiPA-25和Hybribio-23在选定的1731个宫颈拭子和117个组织样本中的性能,重点关注20种常见的HPV类型(14个高风险:16,18,31,33,35,39,45,51,52,56,58,59,66和68/73;6个低风险:6,11,42,43,44和53)。使用Cohen的Kappa(κ)统计量确定两个测定的一致性水平。共有1296个(74.9%)的拭子样本被Hybribio-23或LiPA-25鉴定为HPV阳性,其中814个(62.8%)的样本显示一致,358(27.6%)显示更多或更少的类型(兼容),124(9.6%)不一致。此外,两种检测方法对20种HPV联合检测(κ=0.838)和17种单独的HPV类型(所有κ>0.800)表现出完美的一致性,HPV31(κ=0.792)和43(κ=0.696)的一致性很好,HPV42的一致性中等(κ=0.504)。与LiPA-25相比,Hybribio-23对HPV58、59、68/73、42、43和44的敏感性明显更高,对HPV35和66的敏感性较低(McNemar检验:所有P<0.05)。对于117个HPV阳性组织标本,基因型鉴定为85.2%相同,12.2%兼容,只有2.6%的人不和谐。HPV31的协议(κ=0.786),68/73(κ=0.742)和HPV53(κ=0.742)良好,而对于其他类型(均κ>0.853)和20种HPV联合检测(κ=0.936)均完美(均P>0.05)。总之,杂交生物-23和LiPA-25是相当的。Hybribio-23可用于宫颈样本中HPV的检测和基因分型,用于全球范围内的流行病学和疫苗研究。本文受版权保护。保留所有权利。
The SPF10-polymerase chain reaction (PCR)-based line probe assay (LiPA-25) with high analytical sensitivity and specificity for human papillomavirus (HPV) genotyping in clinical samples has been widely used in vaccine and epidemiologic studies. A real-time multiplex PCR assay using type-specific primers (Hybribio-23) with low workload and cost has been developed recently. The study aimed to compare the performance of LiPA-25 and Hybribio-23 in selected 1731 cervical swab and 117 tissue samples, with a focus on 20 common HPV types (14 high-risk: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68/73; 6 low-risk: 6, 11, 42, 43, 44, and 53). The level of agreement of two assays was determined using Cohen\'s Kappa (κ) statistics. A total of 1296 (74.9%) swab samples were identified as HPV-positive by Hybribio-23 or LiPA-25, of which 814 (62.8%) samples exhibited concordant, 358 (27.6%) showed additional or fewer types (compatible), and 124 (9.6%) were discordant. In addition, the two assays showed a perfect agreement for 20 HPV-combined detection (κ = 0.838) and 17 individual HPV types (all κ > 0.800), a good agreement for HPV31 (κ = 0.792) and 43 (κ = 0.696), and a moderate agreement for HPV42 (κ = 0.504). Hybribio-23 was significantly more sensitive for HPV58, 59, 68/73, 42, 43, and 44, and less sensitive for HPV35 and 66 than LiPA-25 (McNemar\'s test: all p < 0.05). For 117 HPV-positive tissue specimens, the identification of genotypes was 85.2% identical, 12.2% compatible, and only 2.6% discordant. The agreement for HPV31 (κ = 0.786), 68/73 (κ = 0.742), and HPV53 (κ = 0.742) was good, while for other types (all κ > 0.853) and 20 HPV-combined detection (κ = 0.936) was perfect (all p > 0.05). In conclusion, Hybribio-23 and LiPA-25 are comparable. Hybribio-23 could be used for the detection and genotyping of HPV in cervical samples for epidemiological and vaccine studies worldwide.