Department of Laboratory Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, 31 Soonchunhyang 6 gil, Dongnam-gu, Cheonan, Korea.
Department of Pharmaceutical Engineering, Soonchunhyang University College of Medical Sciences, Asan, Korea.
Arch Virol. 2018 Apr;163(4):969-976. doi: 10.1007/s00705-017-3687-4. Epub 2018 Jan 11.
Human papillomavirus (HPV) is a major cause of cervical neoplasia development. HPV screening is very important because early treatment can prevent cervical cancer. Omniplex-HPV is a polymerase chain reaction followed by Luminex xMAP bead microarray technology that is designed for detecting 40 HPV genotypes. The aim of this study is to evaluate the analytical and clinical performance of the Omniplex-HPV in comparison with that of the commercially available RFMP (restriction fragment mass polymorphism) HPV PapilloTyper. A total of 2,808 cervical swab specimens were obtained. Of these, only 1799 specimens had a cytology result. A type-specific direct sequencing test was performed using the reference method in case of discrepancies between the two test results. The overall percent agreement (OPA) between Omniplex-HPV and RFMP HPV PapilloTyper was 97.9% (κ=0.84; 95% CI: 0.81-0.88). The positive percent agreement (PPA) and the negative percent agreement (NPA) were 98.0% and 96.2%, respectively. The Omniplex-HPV and RFMP HPV PapilloTyper showed comparable sensitivities (90.2% and 91.9%, respectively) and specificities (91.3% each), while the Omniplex-HPV produced more accurate results and required less turnaround time and labor. The agreement between these two methods was excellent for HPV genotyping (P>0.05; McNemar's test), and clinical sensitivity, specificity, and odds ratio of the two assays were comparable to the result of cytology tests in identifying high risk HPV. In conclusion, Omniplex-HPV and RFMP HPV PapilloTyper were highly comparable with regard to detection and genotyping analysis of HPV.
人乳头瘤病毒（HPV）是宫颈癌发展的主要原因。HPV 筛查非常重要，因为早期治疗可以预防宫颈癌。Omniplex-HPV 是一种聚合酶链反应（PCR），随后采用 Luminex xMAP 珠微阵列技术，用于检测 40 种 HPV 基因型。本研究旨在评估 Omniplex-HPV 与市售 RFMP（限制性片段质量多态性）HPV PapilloTyper 的分析和临床性能。共获得 2808 例宫颈拭子标本。其中，只有 1799 例标本具有细胞学结果。在两种检测结果不一致的情况下，采用参考方法进行 HPV 型特异性直接测序检测。Omniplex-HPV 与 RFMP HPV PapilloTyper 的总一致性百分比（OPA）为 97.9%（κ=0.84；95%CI：0.81-0.88）。阳性一致性百分比（PPA）和阴性一致性百分比（NPA）分别为 98.0%和 96.2%。Omniplex-HPV 和 RFMP HPV PapilloTyper 的灵敏度相当（分别为 90.2%和 91.9%），特异性均为 91.3%，而 Omniplex-HPV 产生的结果更准确，所需周转时间和劳动力更少。这两种方法在 HPV 基因分型方面的一致性非常好（P>0.05；McNemar 检验），两种检测方法的临床敏感性、特异性和比值比与细胞学检测在识别高危 HPV 方面的结果相当。总之，Omniplex-HPV 和 RFMP HPV PapilloTyper 在 HPV 的检测和基因分型分析方面具有高度可比性。
