BACKGROUND The VALidation of HPV GENoyping Tests (VALGENT) framework is designed for comparison and clinical validation of HPV assays. OBJECTIVES To evaluate the accuracy of the HPV-Risk assay within VALGENT-4, relative to clinically validated comparator HPV tests. STUDY DESIGN The VALGENT-4 panel comprises consecutive SurePath cervical samples from routine screening (n=998), of which 51 had abnormal cytology and 13 women had cervical intraepithelial neoplasia (CIN) grade 2 or worse (CIN2+), enriched with SurePath cervical samples from 297 women with abnormal cytology and 109 CIN2+. HPV-Risk assay was performed on DNA extracted panel samples (n=1,295), blinded to clinical data, cytology results, and results from other HPV assays evaluated in VALGENT-4. All assay results were reported to the central VALGENT coordination institute for data and statistical analysis. HPV prevalence was analysed and accuracy for detection of CIN grade 3 or worse (CIN3+) and CIN2+ were assessed relative to GP5+/6+-PCR-EIA and GP5+/6+-PCR-EIA-LMNX. RESULTS The sensitivity of the HPV-Risk assay for detection of CIN3+ and CIN2+ was similar to that of GP5+/6+-PCR-EIA (relative sensitivity for CIN3+1.01; 95%CI: 0.97-1.06; pMcN=1.000, and for CIN2+1.01; 95%CI: 0.96-1.06; pMcN=1.000) at significantly higher specificity (relative specificity 1.04; 95%CI: 1.02-1.06; pMcN<0.001). The accuracy of the HPV-Risk assay for CIN3+ and CIN2+ was non-inferior compared to GP5+/6+-PCR- EIA and GP5+/6+-PCR-EIA-LMNX, with all p-values ≤0.002. HPV16/18 genotype agreement between HPV-Risk assay and GP5+/6+-PCR-LMNX was high. CONCLUSIONS The HPV-Risk assay demonstrated non-inferiority to clinically validated comparator assays on cervical samples in SurePath medium using the VALGENT-4 panel, and is therefore suitable for cervical cancer screening.

中文翻译：

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使用VALGENT-4面板对SurePath培养基中子宫颈样品进行HPV风险测定的临床表现。

背景技术对HPV基因型检测（VALGENT）框架的验证旨在用于HPV检测的比较和临床验证。目的相对于临床验证的比较器HPV检测，评估VALGENT-4中HPV风险检测的准确性。研究设计VALGENT-4小组包括来自常规筛查的连续SurePath宫颈样本（n = 998），其中51例细胞学异常，13例宫颈上皮内瘤变（CIN）2级或更差的女性（CIN2 +），并富含SurePath宫颈癌样品来自297位细胞学异常的女性和109位CIN2 +的女性。在提取的DNA样本样品（n = 1,295）上进行了HPV风险测定，不了解临床数据，细胞学结果以及在VALGENT-4中评估的其他HPV测定的结果。所有测定结果均报告给中央VALGENT协调机构进行数据和统计分析。相对于GP5 + / 6 + -PCR-EIA和GP5 + / 6 + -PCR-EIA-LMNX，分析了HPV患病率并评估了CIN 3级或更差（CIN3 +）和CIN2 +的检测准确性。结果HPV风险测定对CIN3 +和CIN2 +的检测灵敏度与GP5 + / 6 + -PCR-EIA相似（对CIN3 + 1.01; 95％CI：0.97-1.06; pMcN = 1.000，相对灵敏度） CIN2 + 1.01； 95％CI：0.96-1.06； pMcN = 1.000）具有明显更高的特异性（相对特异性1.04； 95％CI：1.02-1.06； pMcN <0.001）。与GP5 + / 6 + -PCR-EIA和GP5 + / 6 + -PCR-EIA-LMNX相比，所有p值≤0.002的HPV-Risk分析CIN3 +和CIN2 +的准确性均不逊色。HPV-Risk分析与GP5 + / 6 + -PCR-LMNX之间的HPV16 / 18基因型一致性很高。