A comparison of Linear Array and Hybrid Capture 2 for detection of carcinogenic human papillomavirus and cervical precancer in ASCUS-LSIL triage study
A comparison of Linear Array and Hybrid Capture 2 for detection of carcinogenic human papillomavirus and cervical precancer in ASCUS-LSIL triage study
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DOI：
10.1158/1055-9965.epi-07-2904
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发表时间：
2008-05-01
影响因子：
3.8
通讯作者：
Castle, Philip E.
中科院分区：
文献类型：
--
作者：
Gravitt, Patti E.;Schiffman, Mark;Castle, Philip E.
背景资料：我们感兴趣的是比较线性阵列（LA; Roche Molecular Systems）至Hybrid Capture 2（hc 2; Digene）用于检测致癌性人乳头瘤病毒（HPV）和宫颈癌前病变。LA和hc 2的结果进行了比较，基线标本收集自妇女与非典型鳞状细胞的意义不明（ASCUS），巴氏涂片转介到ASCUS和低，鳞状上皮内病变分级分类研究（n= 3，488）。在对液体细胞学标本进行研究时进行HC 2。对来自第二份储存宫颈标本的等分试样进行回顾性LA，该标本对hc 2结果和临床数据设盲。配对LA和hc 2结果（n= 3，289; 94%）进行比较，以检测致癌HPV（HPV 16、18、31、33、35、39、45、51、52、56、58、59、66和68）和2年累积宫颈上皮内瘤样病变（CIN）等级：3，由质量控制病理学审查诊断。LA比hc 2更可能检测出致癌HPV阳性（55%对53%; P=0.001）。对于2年累积>= CIN 3，LA和hc 2的敏感性相似（分别为93.3%和92.6%; P=1），LA的特异性略低于hc 2（分别为48.1%和50.6%; P=0.05）。LA和HC 2的阴性预测值相似（分别为98.70%和98.64%; P=0.4），LA的阳性预测值略低于hc 2（分别为14.6%和15.1%; P < 0.0001）。我们观察到LA和hc 2在检测致癌HPV和鉴定患有ASCUS Pap的妇女中的CIN 3方面表现相似。
Background: We were interested in comparing the performance of Linear Array (LA; Roche Molecular Systems) to Hybrid Capture 2 (hc2; Digene) for the detection of carcinogenic human papillomavirus (HPV) and cervical precancer.Methods: LA and hc2 results were compared on baseline specimens collected from women with an atypical squamous cells of undetermined significance (ASCUS) Pap referred into ASCUS and Low-Grade Squamous Intraepithelial Lesion Triage Study (n=3,488). hc2 was conducted at the time of the study on liquid cytology specimens. LA was conducted retrospectively on aliquots from a second, stored cervical specimen masked to the hc2 results and clinical data. Paired LA and hc2 results (n=3,289; 94%) were compared for the detection of carcinogenic HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and 2-year cumulative cervical intraepithelial neoplasia (CIN) grade : 3 as diagnosed by the quality-control pathology review.Results: LA was more likely to test positive for carcinogenic HPV than hc2 (55% versus 53%; P=0.001). For 2-year cumulative >= CIN3, LA and hc2 had similar sensitivities (93.3% versus 92.6%, respectively; P=1), and LA was marginally less specific than hc2 (48.1% versus 50.6%, respectively; P=0.05). LA and hc2 had similar negative predictive values (98.70% versus 98.64% respectively; P=0.4), and LA had a slightly lower positive predictive value than hc2 (14.6% versus 15.1%, respectively; P < 0.0001).Conclusion: We observed that LA and hc2 performed similarly in the detection of carcinogenic HPV and identification of CIN3 among women with an ASCUS Pap.