Cross-sectional comparison of an automated hybrid capture 2 assay and the consensus GP5+/6+PCR method in a population-based cervical screening program
Cross-sectional comparison of an automated hybrid capture 2 assay and the consensus GP5+/6+PCR method in a population-based cervical screening program
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DOI：
10.1128/jcm.02078-05
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发表时间：
2006-10-01
影响因子：
9.4
通讯作者：
Snijders, P. J. F.
中科院分区：
文献类型：
--
作者：
Hesselink, A. T.;Bulkmans, N. W. J.;Snijders, P. J. F.
在这项横断面研究中，使用参加人群筛查试验的8132名妇女的宫颈刮片样本，比较了使用自动化仪器(即快速捕获系统)的杂交捕获2检测(HC2-RCS)和高危人乳头瘤病毒GP5+/6+PCR-酶免疫分析(EIA)检测的临床表现。HC2-RCS检测阳性标本(6.8%)明显多于GP5+/6+聚合酶链式反应(4.8%)(P<；0.0005)。这在很大程度上可以归因于细胞学正常、交界性或轻度核异常的妇女的HC2-RCS检测的阳性率较高。对不同细胞学类别的半定量HC2-RCS结果的接收者操作员特征分析表明，这些差异是由于检测阈值的不同。对于中度核异常或更严重的妇女，同时有潜在的组织学证实的宫颈上皮内瘤变3级或宫颈癌(>；=CIN3)，HC2-RCS的阳性样本得分为97%(31/32)，而GP5+/6+PCR-EIA的阳性样本得分为91%(29/32)。但差异无统计学意义(P=0.25)。当Hc2-RCS从1.0RLU/CO增加到2.0后，Hc2-RCS没有漏掉更多的CIN3病变，但正常、交界性或轻度核异常的检测阳性妇女的数量显著减少(P<；0.0005)。然而，在此RLU/CO下，HC2-RCS与GP5+/6+PCR-EIA之间的检测阳性率仍有显著差异(P=0.02)。当RLU/CO值为3.0时，HC2-RCS和GP5+/6+PCR-EIA结果之间没有显著差异，两种方法均可检测到相同数量的涂片，分类为>；=CIN3(即29/32)。总之，在以人群为基础的宫颈筛查环境中，这两种检测方法在检测>；=CIN3方面都表现得非常好。然而，将HC2-RCS阈值调整为RLU/CO值2.0或3.0似乎在以人群为基础的宫颈筛查中改善了>；=CIN3的临床敏感性和特异性之间的平衡。
In this cross-sectional study, clinical performances of the hybrid capture 2 assay using an automated instrument (i.e., rapid capture system) (hc2-RCS) and the high-risk human papillomavirus GP5+/6+ PCR-enzyme immunoassay (EIA) test were compared using cervical scrape specimens from 8,132 women that participated in a population-based screening trial. The hc2-RCS test scored significantly more samples positive (6.8%) than the GP5+/6+ PCR-EIA (4.8%) (P < 0.0005). This could be attributed largely to a higher positivity rate by the hc2-RCS test for women with cytologically normal, borderline, or mild dyskaryosis. A receiver operator characteristics analysis of the semiquantitative hc2-RCS results in relation to different cytology categories revealed that these differences are owing to differences in assay thresholds. For women classified as having moderate dyskaryosis or worse who also had underlying histologically confirmed cervical intraepithelial neoplasia grade 3 or cervical cancer (>= CIN3), the hc2-RCS scored 97% (31/32) of samples positive, versus 91% (29/32) by GP5+/6+ PCR-EIA. However, this difference was not significant (P = 0.25). After increasing the hc2-RCS cutoff from 1.0 to 2.0 relative light units/cutoff value of the HPV16 calibrator (RLU/CO), no additional CIN3 lesions were missed by hc2-RCS, but the number of test-positive women with normal, borderline, or mild dyskaryosis was significantly decreased (P < 0.0005). However, at this RLU/CO, the difference in test positivity between hc2-RCS and the GP5+/6+ PCR-EIA was still significant (P = 0.02). The use of an RLU/CO value of 3.0 revealed no significant difference between hc2-RCS and GP5+/6+ PCR-EIA results, and equal numbers of smears classified as >= CIN3 (i.e., 29/32) were detected by both methods. In summary, both assays perform very well for the detection of >= CIN3 in a population-based cervical screening setting. However, adjustment of the hc2-RCS threshold to an RLU/CO value of 2.0 or 3.0 seems to produce an improved balance between the clinical sensitivity and specificity for >= CIN3 in population-based cervical screening.