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首页> 外文期刊>Journal of Clinical Microbiology >Clinical and Analytical Performance of the Onclarity HPV Assay Using the VALGENT Framework
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Clinical and Analytical Performance of the Onclarity HPV Assay Using the VALGENT Framework

机译：使用VALGENT框架进行的HPHP浊度分析的临床和分析性能

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As the demand for human papillomavirus (HPV)-related cervical screening increases, emerging HPV tests must be evaluated robustly using well-annotated samples, such as those generated in the Validation of HPV Genotyping Tests (VALGENT) framework. Through VALGENT, we assessed the performance of the BD Onclarity HPV assay, which detects 14 high-risk (HR) types and resolves six individual types and three groups of types. Consecutive samples from a screening population (n = 1,000), enriched with cytologically abnormal samples (n = 300), that had been tested previously with the GP5+/6+ PCR enzyme immunoassay (EIA) and the GP5+/6+ PCR LMNX assay (Diassay) were tested with the Onclarity assay. Type-specific HPV prevalences were analyzed according to age and cytological result. The accuracy of the Onclarity assay for the detection of cervical intraepithelial neoplasia grade 2+ (CIN2+) and CIN3+ was assessed relative to the GP5+/6+ EIA results by using noninferiority criteria. Overall agreement and type-specific agreement between the Onclarity assay and the GP5+/6+ LMNX assay were assessed. The prevalence of HPV types 16, 18, 31, and 45 increased with the severity of cytological results (P for trend, <0.05). For the detection of CIN2+, the Onclarity assay had a relative sensitivity of 1.02 (95% confidence interval [CI], 0.99 to 1.05; P < 0.001 for noninferiority) and a relative specificity of 0.99 (95% CI, 0.97 to 1.00; P = 0.186 for noninferiority). The kappa for agreement between the Onclarity assay and the GP5+/6+ LMNX assay for HR-HPV was 0.92 (95% CI, 0.89 to 0.94), and values for the six individual types ranged from 0.78 (95% CI, 0.68 to 0.87) for HPV-52 to 0.96 (95% CI, 0.93 to 0.99) for HPV-16. These data suggest that the Onclarity assay offers applications for clinical workstreams while providing genotyping information that may be useful for risk stratification beyond types 16 and 18.
机译：随着对人类乳头瘤病毒（HPV）相关子宫颈筛查的需求增加，必须使用带有批注的样本（例如在“ HPV基因分型检验”（VALGENT）验证框架中生成的样本）对新兴的HPV检验进行稳健的评估。通过VALGENT，我们评估了BD Onclarity HPV检测的性能，该检测可检测14种高风险（HR）类型并解析6种单独类型和3类类型。来自筛查人群（ n = 1,000）的连续样本，富含细胞学异常样本（ n = 300），之前已使用GP5 + / 6 + PCR酶进行过测试免疫测定（EIA）和GP5 + / 6 + PCR LMNX测定（Diassay）用Onclarity测定进行了测试。根据年龄和细胞学结果分析特定类型HPV的患病率。通过使用非劣效性标准相对于GP5 + / 6 + EIA结果评估了Onclarity检测法检测2级以上宫颈上皮内瘤变（CIN2 +）和CIN3 +的准确性。评估了Onclarity检测与GP5 + / 6 + LMNX检测之间的总体一致性和特定类型一致性。随着细胞学结果的严重性，HPV 16、18、31和45型的患病率增加（趋势的 P ，<0.05）。对于CIN2 +的检测，Onclarity分析的相对灵敏度为1.02（95％置信区间[CI]为0.99至1.05;非劣效性 P <0.001），相对特异性为0.99（95％）。 CI，从0.97到1.00;对于非自卑者， P = 0.186）。 HR-HPV的Onclarity检测与GP5 + / 6 + LMNX检测之间达成一致的kappa为0.92（95％CI，0.89至0.94），六种单独类型的值介于0.78（95％CI，0.68至0.87）之间）（对于HPV-16，HPV-52至0.96（95％CI，0.93至0.99））。这些数据表明，Onclarity测定法可为临床工作流程提供应用，同时提供基因分型信息，这些信息可能对16和18型以外的风险分层有用。

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