Song Seung Hun, Hong Jin Hwa, Kwak San Ha, Lee Jae Kwan, Kim Mi Kyung
Department of Obstetrics and Gynecology, Guro Hospital, College of Medicine, Korea University, Goyang, Korea.
J Obstet Gynaecol Res. 2012 Feb;38(2):408-14. doi: 10.1111/j.1447-0756.2011.01709.x. Epub 2011 Dec 19.
To evaluate the performance of five HPV tests (Hybrid Capture 2, Linear Array [LA], DNA chip, type-specific polymerase chain reaction [PCR], and sequencing) in detecting high-risk (HR) HPV DNA and high-grade cervical intraepithelial neoplasia (CIN) and cancer.
A total of 137 women with abnormal cytologies were prospectively enrolled. The diagnostic accuracy of five HPV DNA tests in detecting high-grade CIN and cancer was assessed, and the concordance among HPV genotyping tests was evaluated. All specimens were obtained from cervical swab samples preserved in residual PreservCyt solution that were originally collected for ThinPrep Pap test.
The sensitivities of all five HPV tests did not differ significantly among the five HPV tests. The overall concordance level was excellent between LA and sequencing (98.2%, Kappa = 0.9) and was substantial between DNA chip and sequencing (96.4%, Kappa = 0.8). The concordance levels for detecting vaccine-type (HPV 16 and 18) of LA in comparison with DNA chip, type-specific PCR, and sequencing were substantial (Kappa = 0.67, 0.64, and 0.65, respectively). The sensitivities for all five HPV tests were >90% for the detection of CIN2 or higher. No statistically significant differences in sensitivity occurred between any of the tests.
All five HPV tests showed reliable results in detecting HR HPVs, high-grade CIN, and cancer. Both LA and DNA chip tests may be useful in identifying HR HPV, especially when multiple genotypes are present.
评估五种人乳头瘤病毒（HPV）检测方法（杂交捕获2代、线性阵列[LA]、DNA芯片、型特异性聚合酶链反应[PCR]和测序）在检测高危（HR）HPV DNA以及高级别宫颈上皮内瘤变（CIN）和癌症方面的性能。
前瞻性纳入137例细胞学异常的女性。评估五种HPV DNA检测方法在检测高级别CIN和癌症方面的诊断准确性，并评估HPV基因分型检测之间的一致性。所有标本均取自保存在残留PreservCyt溶液中的宫颈拭子样本，这些样本最初是为薄层液基细胞学检测采集的。
五种HPV检测方法的敏感性在这五种检测方法之间无显著差异。LA与测序之间的总体一致性水平极佳（98.2%，Kappa = 0.9），DNA芯片与测序之间的一致性水平较高（96.4%，Kappa = 0.8）。LA与DNA芯片、型特异性PCR和测序相比，检测疫苗型（HPV 16和18）的一致性水平较高（Kappa分别为0.67、0.64和0.65）。所有五种HPV检测方法检测CIN2或更高病变的敏感性均>90%。任何一种检测方法之间的敏感性均无统计学显著差异。
所有五种HPV检测方法在检测HR HPV、高级别CIN和癌症方面均显示出可靠的结果。LA和DNA芯片检测在识别HR HPV方面可能有用，尤其是当存在多种基因型时。
