Tao Kun, Yang Jing, Yang Hua, Guo Zhen-Hua, Hu Yue-Mei, Tan Zhen-Yu, Zhang Feng, Duan Jin-Lin
Department of Pathology, Shanghai Changning District Central Hospital, Shanghai, China.
Diagn Cytopathol. 2014 Mar;42(3):213-7. doi: 10.1002/dc.23025. Epub 2013 Aug 1.
High-risk human papillomavirus (HR HPV) testing is important for the follow-up of patients with cytological abnormalities. This study was undertaken to compare the clinical value of the Cervista and hybrid capture 2 (HC2) tests for detection of HR HPV in cervical lesions. Overall 439 cervical specimens with abnormal cytology and 22 normal cervical specimens were subjected to the Cervista and HC2 tests. HPV positivity and its predictive value for high-grade cervical lesions were assessed. The Cervista and HC2 tests showed comparable HR HPV detection rates in women with all cytological and histological diagnoses, with a positive and negative percent agreement of 90.8% and 64.5%, respectively. The two methods had a same sensitivity of 90% in detecting CIN II or greater cervical lesions, while the specificity for the Cervista test and HC2 assay was 47% and 43%, respectively. The positive rate for the Cervista assay probe set A9 increased with the histological severity, ranging from 25.0% in normal specimens to 69.5% in high-grade lesions. In conclusion, the clinical performance for the Cervista test is as excellent as the HC2 test in detecting HR HPV and predicting high-grade cervical lesions.
高危型人乳头瘤病毒（HR HPV）检测对于细胞学异常患者的随访很重要。本研究旨在比较Cervista检测法和杂交捕获二代（HC2）检测法在检测宫颈病变中HR HPV的临床价值。总共439例细胞学异常的宫颈标本和22例正常宫颈标本接受了Cervista检测法和HC2检测法。评估了HPV阳性率及其对高级别宫颈病变的预测价值。在所有细胞学和组织学诊断的女性中，Cervista检测法和HC2检测法显示出相当的HR HPV检测率，阳性和阴性百分比一致性分别为90.8%和64.5%。两种方法在检测CIN II或更高级别宫颈病变时灵敏度均为90%，而Cervista检测法和HC2检测法的特异性分别为47%和43%。Cervista检测法的A9探针组阳性率随组织学严重程度增加，从正常标本中的25.0%到高级别病变中的69.5%不等。总之，Cervista检测法在检测HR HPV和预测高级别宫颈病变方面的临床性能与HC2检测法一样出色。
