Hesselink A T, Bulkmans N W J, Berkhof J, Lorincz A T, Meijer C J L M, Snijders P J F
Dept. of Pathology, VUmc, de Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.
J Clin Microbiol. 2006 Oct;44(10):3680-5. doi: 10.1128/JCM.02078-05.
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 (> or =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 > or =CIN3 (i.e., 29/32) were detected by both methods. In summary, both assays perform very well for the detection of >or =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 > or =CIN3 in population-based cervical screening.
在这项横断面研究中，使用来自参与一项基于人群的筛查试验的8132名女性的宫颈刮片标本，比较了使用自动化仪器（即快速捕获系统）的杂交捕获2检测法（hc2-RCS）和高危型人乳头瘤病毒GP5+/6+聚合酶链反应-酶免疫测定（EIA）检测的临床性能。hc2-RCS检测法检测出的阳性样本比例（6.8%）显著高于GP5+/6+ PCR-EIA检测法（4.8%）（P<0.0005）。这在很大程度上可归因于hc2-RCS检测法对细胞学正常、临界或轻度核异质女性的阳性率更高。对hc2-RCS半定量结果与不同细胞学类别进行的受试者工作特征分析表明，这些差异是由于检测阈值的不同。对于被分类为中度核异质或更严重且组织学确诊为宫颈上皮内瘤变3级或宫颈癌（≥CIN3）的女性，hc2-RCS检测出97%（31/32）的样本为阳性，而GP5+/6+ PCR-EIA检测出91%（29/32）的样本为阳性。然而，这种差异并不显著（P = 0.25）。将hc2-RCS的临界值从相对于HPV16校准品的1.0相对光单位/临界值（RLU/CO）提高到2.0后，hc2-RCS没有漏诊额外的CIN3病变，但细胞学正常、临界或轻度核异质的检测阳性女性数量显著减少（P<0.0005）。然而，在此RLU/CO值下，hc2-RCS与GP5+/6+ PCR-EIA之间的检测阳性差异仍然显著（P = 0.02）。使用3.0的RLU/CO值时，hc2-RCS与GP5+/6+ PCR-EIA结果之间没有显著差异，两种方法检测出的分类为≥CIN3的涂片数量相等（即29/32）。总之，在基于人群的宫颈筛查中，两种检测方法在检测≥CIN方面都表现良好。然而，将hc2-RCS阈值调整为2.
