Yin Jian, Peng Siying, Zhang Changning, Li Xinyue, Hu Fangfang, Chen Wen, Qiao Youlin
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.
J Med Virol. 2023 Feb;95(2):e28579. doi: 10.1002/jmv.28579.
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.
基于SPF10聚合酶链反应（PCR）的线性探针分析（LiPA-25）对临床样本中的人乳头瘤病毒（HPV）基因分型具有较高的分析灵敏度和特异性，已广泛应用于疫苗和流行病学研究。最近开发了一种使用型特异性引物的实时多重PCR分析（Hybribio-23），其工作量和成本较低。本研究旨在比较LiPA-25和Hybribio-23在1731份宫颈拭子和117份组织样本中的性能，重点关注20种常见HPV类型（14种高危型：16、18、31、33、35、39、45、51、52、56、58、59、66以及68/73；6种低危型：6、11、42、43、44和53）。使用科恩kappa（κ）统计量确定两种分析方法的一致性水平。共有1296份（74.9%）拭子样本被Hybribio-23或LiPA-25鉴定为HPV阳性，其中814份（62.8%）样本结果一致，358份（27.6%）显示出额外或更少的类型（兼容），124份（9.6%）结果不一致。此外，两种分析方法在20种HPV联合检测（κ = 0.838）和17种单个HPV类型（所有κ > 0.800）方面显示出完全一致，在HPV31（κ = 0.792）和43（κ = 0.696）方面显示出良好一致性，在HPV42（κ = 0.504）方面显示出中等一致性。与LiPA-25相比，Hybribio-23对HPV58、59、68/73、42、43和44的敏感性显著更高，对HPV35和66的敏感性更低（麦克尼马尔检验：所有p < 0.05）。对于117份HPV阳性组织标本，基因型鉴定的一致性为85.2%，兼容性为12.2%，不一致性仅为2.6%。HPV31（κ = 0.786）、68/73（κ = 0.742）和HPV53（κ = 0.742）的一致性良好，而其他类型（所有κ > 0.853）和20种HPV联合检测（κ = 0.936）的一致性完美（所有p > 0.05）。总之，Hybribio-23和LiPA-25具有可比性。Hybribio-23可用于全球范围内宫颈样本中HPV的检测和基因分型，以进行流行病学和疫苗研究。
