Department of Pathology, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.
Department of Pathology, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.
J Clin Virol. 2018 Dec;109:13-18. doi: 10.1016/j.jcv.2018.10.004. Epub 2018 Oct 13.
High-risk human papillomavirus (hrHPV) detection and genotyping by Cobas HPV test has become an important technical platform in cervical cancer screening. It may be used as a co-test with cervical cytology or as a standalone test. Aptima HPV assay (AHPV) is another hrHPV test detecting 13 genotypes through qPCR based amplification of viral E6/E7 transcripts. Partial genotyping with Aptima HPV 16 18/45 genotype assay (AHPV GT) on positive samples is possible. Evidence supporting the performance of AHPV in Asian populations is scarce.
To compare the performances of Cobas and AHPV in detection of cervical squamous intraepithelial lesions (SIL) and triage of cytologically equivocal smears in a cohort of Hong Kong women.
442 liquid based cytology (LBC) residues with biopsy confirmed diagnoses were evaluated by both AHPV and Cobas HPV tests.
Overall, there was a moderate agreement between AHPV and Cobas (κ = 0.5082, 95% CI: 0.492-0.672). The sensitivities of AHPV and Cobas for detecting biopsy confirmed HSIL or worse lesions (HSIL+) were 96.71% (95% CI: 92.49%-98.92%) and 97.37% (95% CI: 93.40%-99.28%) respectively. AHPV demonstrated significantly higher specificity than Cobas (37.85% vs 23.96%, p < 0.0001). Both tests could identify all ASC-US and AGC cases with HSIL + in follow-up biopsies, but AHPV showed a significantly higher specificity in both settings (ASC-US: 28.81% vs 11.86%, p < 0.0001; AGC: 55.00% vs 20.00%, p = 0.0233).
Both AHPV and Cobas were equally sensitive in detecting high-grade SIL in both scenarios of screening and ASC-US or AGC triage but AHPV showed a higher specificity.
高危型人乳头瘤病毒（hrHPV）检测和基因分型通过 Cobas HPV 检测已成为宫颈癌筛查的重要技术平台。它可以与宫颈细胞学检查联合使用，也可以单独使用。Aptima HPV 检测（AHPV）是另一种通过基于 qPCR 的病毒 E6/E7 转录物扩增检测 13 种基因型的 hrHPV 检测。对阳性样本进行 Aptima HPV 16 18/45 基因型检测（AHPV GT）可进行部分基因分型。支持 AHPV 在亚洲人群中表现的证据很少。
比较 Cobas 和 AHPV 在香港女性人群中检测宫颈鳞状上皮内病变（SIL）和细胞学不确定涂片分流中的性能。
对 442 例液基细胞学（LBC）残留标本进行评估，采用 AHPV 和 Cobas HPV 检测。
总体而言，AHPV 与 Cobas 之间存在中度一致性（κ=0.5082，95%CI：0.492-0.672）。AHPV 和 Cobas 检测活检证实的高级别鳞状上皮内病变（HSIL+）的敏感性分别为 96.71%（95%CI：92.49%-98.92%）和 97.37%（95%CI：93.40%-99.28%）。AHPV 的特异性明显高于 Cobas（37.85% vs 23.96%，p<0.0001）。两种检测均能识别所有 ASC-US 和 AGC 病例中伴有后续活检 HSIL+的病例，但 AHPV 在两种情况下的特异性均显著更高（ASC-US：28.81% vs 11.86%，p<0.0001；AGC：55.00% vs 20.00%，p=0.0233）。
在筛查和 ASC-US 或 AGC 分流的两种情况下，AHPV 和 Cobas 在检测高级别 SIL 方面均具有同等敏感性，但 AHPV 的特异性更高。
