Lee Jae Kwan, Kim Mi Kyung, Song Seung Hun, Hong Jin Hwa, Min Kyung Jin, Kim Jae Hoon, Song Eun-Seop, Lee Jungpil, Lee Jong-Min, Hur Soo-Young
Department of Obstetrics and Gynecology, Korea University College of Medicine, Korea.
Int J Gynecol Cancer. 2009 Feb;19(2):266-72. doi: 10.1111/IGC.0b013e31819bcd0a.
Although the Hybrid Capture II (HC II) assay can detect 13 high-risk human papillomavirus (HPVs), it does not yield any genotype-specific information. We evaluated the performance of 4 HPV DNA tests, namely, HC II, Linear Array (LA), DNA chip, and cycle sequencing for their capacity to detect the presence of high-risk HPV DNA and HPV-associated cervical lesions. Seventy-six women who were referred to the colposcopy clinic for abnormal cytology were enrolled. The women were examined using liquid-based cytology, colposcopy-directed biopsy, and HPV DNA tests. After DNA extraction from a single sample, HPV DNA tests were performed by all 4 methods on the same specimen. The LA test has higher HPV-positive rates than HC II for cervical intraepithelial neoplasia I (83.3% vs 61.1%; P < 0.01) and for cervical intraepithelial neoplasia II and more severe lesions (100.0% vs 80.0%; P < 0.01). The concordance between the DNA chip and LA tests was 89.5%, confirming substantial agreement (kappa coefficient = 0.73), and the concordance between HC II and the DNA chip was 80.3%, also showing substantial agreement (kappa coefficient = 0.738). The concordance for 15 high-risk HPV genotypes between LA and sequencing was 82.5% with a kappa value of 0.536. Furthermore, the LA test was more sensitive in the detection of high-grade cervical lesions than HC II (100% vs 92.3%, P < 0.01). The LA test showed superior sensitivity in the detection of clinically relevant HPV infections and has proven to be an accurate tool for identifying individual HPV types, especially in cases of multiple HPV infections.
尽管杂交捕获二代(HC II)检测法能够检测13种高危型人乳头瘤病毒(HPV),但它无法提供任何基因型特异性信息。我们评估了4种HPV DNA检测方法,即HC II、线性阵列(LA)、DNA芯片和循环测序法,检测高危型HPV DNA及HPV相关宫颈病变的能力。纳入了76名因细胞学异常而转诊至阴道镜门诊的女性。对这些女性进行了液基细胞学检查、阴道镜引导下活检及HPV DNA检测。从单个样本中提取DNA后,用这4种方法对同一份标本进行HPV DNA检测。对于宫颈上皮内瘤变I,LA检测法的HPV阳性率高于HC II(83.3%对61.1%;P<0.01);对于宫颈上皮内瘤变II及更严重病变,LA检测法的HPV阳性率也高于HC II(100.0%对80.0%;P<0.01)。DNA芯片检测法与LA检测法之间的一致性为89.5%,证实有高度一致性(kappa系数=0.73);HC II检测法与DNA芯片检测法之间的一致性为80.3%,也显示有高度一致性(kappa系数=0.738)。LA检测法与测序法对15种高危型HPV基因型的一致性为82.5%,kappa值为0.536。此外,LA检测法在检测高级别宫颈病变方面比HC II更敏感(100%对92.3%,P<0.01)。LA检测法在检测临床相关HPV感染方面显示出更高的敏感性,已被证明是鉴定个体HPV类型的准确工具,尤其是在多重HPV感染的情况下。