CLART HPV 4S 检测在丹麦宫颈癌筛查项目中应用于 SurePath 筛查样本的临床和分析性能，使用 VALGENT 框架。
Clinical and analytical performance of the CLART HPV 4S assay with SurePath screening samples from the Danish cervical cancer screening program using the VALGENT framework.
机构信息
Molecular Pathology Laboratory, Dept of Pathology, Copenhagen University Hospital, Kettegårdsalle 30, 2650, Hvidovre, Denmark.
Molecular Pathology Laboratory, Dept of Pathology, Copenhagen University Hospital, Kettegårdsalle 30, 2650, Hvidovre, Denmark.
出版信息
J Virol Methods. 2021 Jun;292:114118. doi: 10.1016/j.jviromet.2021.114118. Epub 2021 Mar 22.
The CLART HPV4S (CLART4S) is a novel full genotyping assay, based on PCR/microarray technology. We assessed the clinical accuracy of the CLART4S assays under the fourth installment of the VALGENT framework. The VALGENT cohort comprised 998 consecutive cervical samples from women participating in the Danish screening programme enriched with 297 samples with abnormal cytology (100 ASCUS, 100 LSIL, 97 HSIL). The CLART4S assay detects 16 HPV genotypes individually: 14 oncogenic and two non-oncogenic HPV types. The GP5+/6+ PCR Enzyme-Immuno-Assay (GP-EIA) and GP5+/6+ PCR with Luminex genotyping (GP-LMNX) were used as comparator tests for clinical accuracy and HPV genotype concordance, respectively. The sensitivity for ≥ CIN2 for the CLART4S assay was 96.7 % (GP-EIA: 92.6 %) with a relative sensitivity of 1.04 (1.00-1.09). The sensitivity for ≥ CIN3 was 98.8 % (GP-EIA: 94.0 %), with relative sensitivity of 1.05 (1.00-1.10). The specificity for <CIN2 was 88.6 % (GP-EIA: 89.2 %) with a relative specificity of 0.99 (0.98-1.01). The CLART 4S was found to be non-inferior to that of GP-EIA for both sensitivity (p < 0.0001) and specificity (p = 0.0452). The overall oncogenic HPV concordance between CLART4S and GP-LMNX was high, however when looking at individual genotype agreement the concordance was more diverse, with the highest agreement found in the Screening population.
CLART HPV4S（CLART4S）是一种基于 PCR/微阵列技术的新型全基因分型检测方法。我们根据 VALGENT 框架的第四部分评估了 CLART4S 检测方法的临床准确性。VALGENT 队列包括 998 例连续的来自参加丹麦筛查计划的女性宫颈样本，其中 297 例样本伴有异常细胞学（100 例 ASCUS、100 例 LSIL、97 例 HSIL）。CLART4S 检测方法可单独检测 16 种 HPV 基因型：14 种致癌型和 2 种非致癌型 HPV 类型。GP5+/6+PCR 酶免疫测定（GP-EIA）和 GP5+/6+PCR 与 Luminex 基因分型（GP-LMNX）分别用作临床准确性和 HPV 基因型一致性的比较检测方法。CLART4S 检测方法对≥ CIN2 的敏感性为 96.7%（GP-EIA：92.6%），相对敏感性为 1.04（1.00-1.09）。对≥ CIN3 的敏感性为 98.8%（GP-EIA：94.0%），相对敏感性为 1.05（1.00-1.10）。对< CIN2 的特异性为 88.6%（GP-EIA：89.2%），相对特异性为 0.99（0.98-1.01）。CLART 4S 在敏感性（p<0.0001）和特异性（p=0.0452）方面均不劣于 GP-EIA。CLART4S 与 GP-LMNX 之间总体致癌 HPV 一致性较高，但当观察个别基因型一致性时，一致性更加多样化，在筛查人群中一致性最高。
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