Castle Philip E, Eaton Barbara, Reid Jennifer, Getman Damon, Dockter Janel
Albert Einstein College of Medicine, New York, New York, USA.
Hologic, Inc., San Diego, California, USA.
J Clin Microbiol. 2015 Apr;53(4):1277-81. doi: 10.1128/JCM.03558-14. Epub 2015 Feb 4.
Few studies have compared the cobas HPV test to the Aptima HPV assay (AHPV) and the Aptima HPV 16 18/45 genotype assay (AHPV GT) for high-risk human papillomavirus (hrHPV) detection, clinical performance in detecting cervical intraepithelial neoplasia grade 2 (CIN2) or more severe (CIN2+) diagnoses, and risk stratification by partial HPV genotyping. The cobas HPV test is a DNA test that separately and concurrently detects HPV16, HPV18, and a pool of 12 other hrHPV types. AHPV is an RNA test for a pool of 14 hrHPV genotypes, and AHPV GT is an RNA test run on AHPV-positive results to detect HPV16 separately from HPV18 and HPV45, which are detected together. In a population of patients (n=988) referred for colposcopy because of a cervical Pap cytology result of atypical squamous cells of undetermined significance (ASC-US), a cervical scrape specimen was taken, placed into a ThinPrep Pap test vial containing PreservCyt liquid cytology medium, and tested in a blinded fashion with cobas and AHPV and with AHPV GT for AHPV-positive results. The final diagnoses were based on a consensus panel review of the biopsy specimen histology. AHPV and cobas were equally sensitive for CIN2+ diagnoses (89.4% each; P=1.000), and AHPV was more specific than cobas (63.1% versus 59.3%; P≤0.001). The percent total agreement, percent positive agreement, and kappa value were 90.9%, 81.1%, and 0.815, respectively. Risk stratification using partial HPV genotyping was similar for the two assays. AHPV and AHPV GT had similar sensitivity and risk stratification to cobas HPV, but they were more specific than cobas HPV.
很少有研究将cobas HPV检测与Aptima HPV检测法(AHPV)以及Aptima HPV 16 18/45基因型检测法(AHPV GT)进行比较,以用于高危型人乳头瘤病毒(hrHPV)检测、检测宫颈上皮内瘤变2级(CIN2)或更严重病变(CIN2+)诊断的临床性能,以及通过部分HPV基因分型进行风险分层。cobas HPV检测是一种DNA检测,可分别同时检测HPV16、HPV18以及其他12种hrHPV类型的组合。AHPV是针对14种hrHPV基因型组合的RNA检测,AHPV GT是对AHPV阳性结果进行检测的RNA检测,用于将HPV16与HPV18和HPV45分开检测,后两者一起检测。在因宫颈巴氏细胞学结果为意义不明确的非典型鳞状细胞(ASC-US)而转诊进行阴道镜检查的患者群体(n = 988)中,采集宫颈刮片标本,放入含有PreservCyt液体细胞学培养基的ThinPrep巴氏检测瓶中,并以盲法用cobas和AHPV以及对AHPV阳性结果用AHPV GT进行检测。最终诊断基于活检标本组织学的共识小组审查。AHPV和cobas对CIN2+诊断的敏感性相同(均为89.4%;P = 1.000),且AHPV比cobas更具特异性(分别为63.1%和59.3%;P≤0.001)。总一致率、阳性一致率和kappa值分别为90.9%、81.1%和0.815。两种检测方法使用部分HPV基因分型进行风险分层相似。AHPV和AHPV GT与cobas HPV具有相似的敏感性和风险分层,但它们比cobas HPV更具特异性。