Mbulawa Zizipho Z A, Wilkin Timothy J, Goeieman Bridgette, Swarts Avril, Williams Sophie, Levin Simon, Faesen Mark, Smith Jennifer S, Chibwesha Carla J, Williamson Anna-Lise, Firnhaber Cynthia
Institute of Infectious Disease and Molecular Medicine, University of Cape Town, South Africa; Centre for HIV and STIs, National Institute for Communicable Disease, National Health Laboratory Service, South Africa.
Division of Infectious Diseases, Department of Medicine, Weill Cornell Medical College, New York, NY, USA.
Papillomavirus Res. 2016 Dec;2:56-60. doi: 10.1016/j.pvr.2016.02.004. Epub 2016 Mar 3.
This study investigated the performance of Cepheid Xpert human papillomavirus (HPV) assay in South African human immunodeficiency virus (HIV)-infected women and compared its performance with that of hybrid capture-2 (hc2).
Stored cervical specimens from HIV-infected women that had previously been tested using hc2 were tested using Xpert.
The overall HR-HPV prevalence was found to be 62.0% (720/1161) by Xpert and 61.2% (711/1161) by hc2. 13.6% (158/1161) were HPV16 positive, 18.8% (218/1161) were HPV18/45, 37.3% (434/1161) were HPV31/33/35/52/58, 12.7% (147/1161) were HPV51/59 and 23.3% (270/1161) were HPV39/68/56/66. Overall agreement with hc2 was 90%; Cohen's kappa was 0.78 (95% CI 0.74-0.82) indicating substantial agreement. Detection of HPV16, HPV18/45, and HPV31/33/35/52/58 were independently associated with cervical intraepithelial neoplasia (CIN)-2+ (P<0.0001 for each); while HPV51/59 and HPV39/68/56/66 were not. Women infected with HPV16, HPV18/45 or HPV31/33/35/52/58 were found to have significantly higher amounts of HPV DNA detected for those with CIN2+ compared to those without CIN2+, P<0.0001 for each. Xpert and hc2 were similarly sensitive (88.3% and 91.5%, respectively) and specific (48.4% and 51.0%) for CIN2+ and CIN3 (sensitivity: 95.8% and 97.9%; specificity: 41.4% and 42.8%).
Xpert is a promising screening test in HIV-infected women that performs similarly to hc2.
本研究调查了赛沛Xpert人乳头瘤病毒（HPV）检测法在南非感染人类免疫缺陷病毒（HIV）的女性中的表现，并将其与杂交捕获-2（hc2）检测法的表现进行了比较。
对之前使用hc2检测过的感染HIV女性的储存宫颈标本进行Xpert检测。
Xpert检测发现总体高危型HPV（HR-HPV）患病率为62.0%（720/1161），hc2检测为61.2%（711/1161）。13.6%（158/1161）为HPV16阳性，18.8%（218/1161）为HPV18/45，37.3%（434/1161）为HPV31/33/35/52/58，12.7%（147/1161）为HPV51/59，23.3%（270/1161）为HPV39/68/56/66。与hc2的总体一致性为90%；科恩kappa系数为0.78（95%可信区间0.74 - 0.82），表明一致性较高。HPV16、HPV18/45和HPV31/33/35/52/58的检测与宫颈上皮内瘤变（CIN）-2+独立相关（每项P<0.0001）；而HPV51/59和HPV39/68/56/66则不然。与无CIN2+的女性相比，感染HPV16、HPV18/45或HPV31/33/35/52/58的女性中CIN2+者检测到的HPV DNA量显著更高，每项P<0.0001。Xpert和hc2对CIN2+和CIN3的敏感性（分别为88.3%和91.5%）和特异性（分别为48.4%和51.0%）相似（对CIN2+和CIN3的敏感性：分别为95.8%和97.9%；特异性：分别为41.4%和42.8%）。
Xpert是一种有前景的针对感染HIV女性的筛查检测法,其表现与hc2相似。
