Castle Phillip E, Cuzick Jack, Stoler Mark H, Wright Thomas C, Reid Jennifer L, Dockter Janel, Giachetti Cristina, Getman Damon
From the Albert Einstein College of Medicine, Bronx, NY;
Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary School of Medicine, London, England;
Am J Clin Pathol. 2015 Feb;143(2):160-7. doi: 10.1309/AJCPLCD8TTOMLJTB.
The Aptima human papillomavirus (HPV) 16 18/45 Genotype (GT) assay (AHPV-GT) is a qualitative E6/ E7 oncogene messenger RNA test that detects HPV 16 and a pool of HPV 18 and 45. The CLEAR (Clinical Evaluation of APTIMA mRNA) study was the pivotal, prospective, multicenter US clinical study to validate the Aptima HPV (AHPV) assays.
In this analysis, we evaluated the clinical performance of AHPV and AHPV-GT assays for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2 +) and grade 3 (CIN3) or adenocarcinoma in situ in 912 women with atypical squamous cells of undetermined significance (ASC-US) Papanicolaou result. The AHPV-GT assay was performed on high-risk HPV (hrHPV) positives as determined by the AHPV assay.
Overall, the percent positive for hrHPV was 38.8% (354/912), of which 34.2% (121/354) were GT positive. Among hrHPV-positive women, the risks of CIN2 + were 37.0% for HPV 16 positives, 15.9% for HPV 18/45 positives, 14.3% for other hrHPV positives, and 2.2% for AHPV negatives. The risks of CIN3 + were 20.5% for HPV 16 positives, 9.1% for HPV 18/45 positives, 4.3% for other hrHPV positives, and 0.7% for HPV negatives.
We demonstrated that AHPV-GT is a reliable and effective test for cervical cancer risk stratification in women with an ASC-US cytology diagnosis.
Aptima人乳头瘤病毒（HPV）16 18/45基因型（GT）检测法（AHPV-GT）是一种定性E6/E7癌基因信使核糖核酸检测法，可检测HPV 16以及HPV 18和45的组合。CLEAR（Aptima信使核糖核酸的临床评估）研究是美国一项关键的前瞻性多中心临床研究，用于验证Aptima HPV（AHPV）检测法。
在本分析中，我们评估了AHPV和AHPV-GT检测法对912例巴氏涂片结果为意义不明确的非典型鳞状细胞（ASC-US）女性检测宫颈上皮内瘤变2级或更严重（CIN2+）以及3级（CIN3）或原位腺癌的临床性能。AHPV-GT检测法是针对AHPV检测法确定的高危HPV（hrHPV）阳性者进行的。
总体而言，hrHPV阳性率为38.8%（354/912），其中34.2%（121/354）为GT阳性。在hrHPV阳性女性中，HPV 16阳性者CIN2+风险为37.0%，HPV 18/45阳性者为15.9%，其他hrHPV阳性者为14.3%，AHPV阴性者为2.2%。CIN3+风险在HPV 16阳性者中为20.5%，HPV 18/45阳性者中为9.1%，其他hrHPV阳性者中为4.3%，HPV阴性者中为0.7%。
我们证明，AHPV-GT对于ASC-US细胞学诊断的女性宫颈癌风险分层是一种可靠且有效的检测方法。
