Gravitt Patti E, Schiffman Mark, Solomon Diane, Wheeler Cosette M, Castle Philip E
Department of Epidemiology and Molecular Microbiology, Johns Hopkins University, Baltimore, Maryland, USA.
Cancer Epidemiol Biomarkers Prev. 2008 May;17(5):1248-54. doi: 10.1158/1055-9965.EPI-07-2904.
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.
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 >or=3 as diagnosed by the quality-control pathology review.
LA was more likely to test positive for carcinogenic HPV than hc2 (55% versus 53%; P = 0.001). For 2-year cumulative >or=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).
We observed that LA and hc2 performed similarly in the detection of carcinogenic HPV and identification of CIN3 among women with an ASCUS Pap.
我们旨在比较线性阵列检测法（LA；罗氏分子系统公司）与杂交捕获2代检测法（hc2；Digene公司）在检测致癌性人乳头瘤病毒（HPV）及宫颈上皮内瘤变方面的性能。
对在非典型鳞状细胞意义不明确（ASCUS）巴氏涂片检查中被转诊至ASCUS和低度鳞状上皮内病变分流研究的女性（n = 3488）所采集的基线标本进行LA和hc2检测结果的比较。hc2检测在研究时对液基细胞学标本进行。LA检测则对来自第二个储存宫颈标本的等分试样进行回顾性检测，该检测对hc2检测结果和临床数据进行了屏蔽。比较配对的LA和hc2检测结果（n = 3289；94%），以检测致癌性HPV（HPV 16、18、31、33、35、39、45、51、52、56、58、59、66和68）以及通过质量控制病理检查诊断的2年累积宫颈上皮内瘤变（CIN）≥3级。
LA检测致癌性HPV呈阳性的可能性高于hc2（55%对53%；P = 0. 001）。对于2年累积CIN3，LA和hc2具有相似的敏感性（分别为93.3%和92.6%；P = 1），且LA的特异性略低于hc2（分别为48.1%和50.6%；P = 0.05）。LA和hc2具有相似的阴性预测值（分别为98.70%和98.64%；P = 0.4），且LA的阳性预测值略低于hc2（分别为14.6%和15.1%；P < 0.0001）。
我们观察到，在ASCUS巴氏涂片检查的女性中，LA和hc2在检测致癌性HPV及识别CIN3方面表现相似。
