Venturoli Simona, Cricca Monica, Bonvicini Francesca, Giosa Francesco, Pulvirenti Francesco Renato, Galli Claudio, Musiani Monica, Zerbini Marialuisa
Department of Clinical and Experimental Medicine, Section of Microbiology, University of Bologna, Policlinico S. Orsola, Bologna, Italy.
J Clin Virol. 2002 Aug;25(2):177-85. doi: 10.1016/s1386-6532(02)00007-0.
A persistent infection by high-risk HPV is now considered as the major cause of cervical carcinoma. The use of a single cytological specimen for HPV DNA testing by two different molecular methods was analyzed and validated.
HPV DNA testing by PCR-ELISA and hybrid capture II HPV test (HC-II), was investigated on 317 cytological samples obtained from Italian women. Two hundred twenty-seven women were referred to virological lab for HPV DNA testing during cytological routine screening and 90 during a cytological and virological follow-up after a conization or hysterectomy.
Overall, the concordance between the two assays was high (K=0.87). Compared with PCR-ELISA, the HC-II showed a sensitivity of 91.7% and a specificity of 95.4%. Although the analytical sensitivity of the PCR-ELISA was higher, the performance of the two tests did not differ in recognizing HPV DNA positive patients with either low or high-grade squamous intraepithelial lesions (LSIL or HSIL). HPV DNA positivity was directly correlated with the severity of cytological diagnosis (P<0.005).
In view of the comparable results obtained with the two assays and of the ease of use, and higher throughput of HC-II, it seems advisable, with a single cytological specimen, to employ the HC-II test as a first-line assay, either for screening or diagnosis, and to perform reflex PCR on positive samples, if typing of prevalent high risk HPVs is needed.
高危型人乳头瘤病毒（HPV）持续感染现被认为是宫颈癌的主要病因。分析并验证了使用单一细胞学标本通过两种不同分子方法进行HPV DNA检测的情况。
采用聚合酶链反应-酶联免疫吸附测定法（PCR-ELISA）和杂交捕获二代HPV检测法（HC-II）对317例来自意大利女性的细胞学样本进行HPV DNA检测。227名女性在细胞学常规筛查期间被转诊至病毒学实验室进行HPV DNA检测，90名女性在锥切术或子宫切除术后的细胞学和病毒学随访期间进行检测。
总体而言，两种检测方法的一致性较高（K = 0.87）。与PCR-ELISA相比，HC-II的灵敏度为91.7%，特异性为95.4%。尽管PCR-ELISA的分析灵敏度更高，但在识别低级别或高级别鳞状上皮内病变（LSIL或HSIL）的HPV DNA阳性患者方面，两种检测方法的性能并无差异。HPV DNA阳性与细胞学诊断的严重程度直接相关（P<0.005）。
鉴于两种检测方法获得的结果相当，且HC-II使用方便、通量更高，对于单一细胞学标本，似乎建议将HC-II检测作为一线检测方法用于筛查或诊断，若需要对流行的高危型HPV进行分型，则对阳性样本进行反向PCR检测。
