Castle Philip E, Smith Katherine M, Davis Thomas E, Schmeler Kathleen M, Ferris Daron G, Savage Ashlyn H, Gray Jermaine E, Stoler Mark H, Wright Thomas C, Ferenczy Alex, Einstein Mark H
From Global Cancer Initiative, Chestertown, MD;
Oklahoma University Health Sciences Center, Oklahoma City;
Am J Clin Pathol. 2015 Jan;143(1):126-33. doi: 10.1309/AJCP4Q0NSDHWIZGU.
The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform.
In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA).
The κ and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2.
The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.
Xpert HPV检测法（Xpert；赛沛公司，加利福尼亚州桑尼维尔市）是为多分析物GeneXpert平台开发的。
在美国的708名接受阴道镜检查转诊的女性人群中，采集了两份宫颈标本A和B，并都通过Xpert检测法检测高危型人乳头瘤病毒（hrHPV）DNA，从而评估其检测可靠性。标本B还通过杂交捕获2代检测法（hc2；凯杰公司，马里兰州日耳曼敦市）和cobas HPV检测法（cobas；罗氏分子系统公司，加利福尼亚州普莱森顿市）进行检测。
两次Xpert检测结果中任何hrHPV的κ值和一致性百分比分别为0.88和94.5%。Xpert检测两份标本均呈阳性的情况无统计学差异（P = 0.62）。对于检测宫颈上皮内瘤变2级或更严重病变（CIN2+），使用标本A时Xpert检测法的灵敏度为89.0%，使用标本B时为90.4%，cobas检测法为90.4%，hc2检测法为81.6%。
Xpert检测法在检测hrHPV以及识别CIN2+女性方面灵敏且可靠。
