Division of Cancer Epidemiology and Genetics, Clinical Genetics Branch, National Cancer Institute, National Institutes of Health, DHHS, Bethesda, MD, USA.
Int J Cancer. 2012 Dec 15;131(12):2903-9. doi: 10.1002/ijc.27563. Epub 2012 Apr 27.
Success of the new human papillomavirus (HPV) DNA test for low-resource settings (careHPV™ test; QIAGEN Gaithersburg Inc., Gaithersburg, MD) requires good test performance when operated by personnel with limited laboratory experience. We evaluated the transferability, reliability, and accuracy of the careHPV test nested within a cervical screening project in a large Nigerian village. CareHPV testing was performed on screen-positive (n = 345) and screen-negative (n = 42) women attending colposcopy (68.3% of referred). Biopsies of abnormal-appearing areas were processed and read in the U.S. CareHPV specimens taken immediately before colposcopy were processed up to four times (in the field) by two secondary school graduates without laboratory experience, trained for this study. Specifically, QIAGEN Gaithersburg trained a laboratory-inexperienced U.S. researcher, who trained the first local technician who, in turn, trained the second. Residual specimens were sent to the U.S. for MY09/MY11 PCR testing for 13 carcinogenic genotypes (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) plus HPV66 (included in careHPV). Intrarater agreement was 98.8% (κ = 0.97) and 98.9% (κ = 0.97) for Technicians 1 and 2, respectively, while inter-rater agreement was 96.3% (κ = 0.90). Agreement with MY09/MY11 PCR (virologic reference standard) was 89.3% (κ = 0.73) with 74.2% sensitivity and 95.7% specificity. The careHPV test detected 12 (80%) of 15 histologically confirmed cervical intraepithelial neoplasia Grade 2 (CIN2) or worse lesions, with an estimated 83.0% specificity to detect <CIN2. In a challenging low-resource setting with minimal intervention, the careHPV test performed adequately with high specificity but possibly lower sensitivity than HPV DNA tests currently used in controlled situations.
新的人乳头瘤病毒（HPV）DNA 检测在资源有限的环境中的成功（careHPV™ 检测；QIAGEN Gaithersburg Inc.，马里兰州盖瑟斯堡）需要操作人员具有有限的实验室经验时也能获得良好的检测性能。我们评估了在尼日利亚一个大村庄的宫颈筛查项目中嵌套的 careHPV 检测的可转移性、可靠性和准确性。对参加阴道镜检查的 screen-positive（n = 345）和 screen-negative（n = 42）女性进行 careHPV 检测（转诊的 68.3%）。对异常外观区域进行活检，并在美国进行处理和阅读。在没有实验室经验的两名中学毕业生的帮助下，在现场最多可对 careHPV 标本进行四次处理（field），这两名毕业生接受了此项研究的培训。具体而言，QIAGEN Gaithersburg 培训了一位没有实验室经验的美国研究人员，然后该研究人员培训了第一位当地技术员，再由该技术员培训第二位。将剩余的标本寄往美国，用于 13 种致癌基因型（HPV16、18、31、33、35、39、45、51、52、56、58、59、68）加上 HPV66（包含在 careHPV 中）的 MY09/MY11 PCR 检测。技术员 1 和技术员 2 的内部观察者间一致性分别为 98.8%（κ = 0.97）和 98.9%（κ = 0.97），而外部观察者间一致性为 96.3%（κ = 0.90）。与 MY09/MY11 PCR（病毒学参考标准）的一致性为 89.3%（κ = 0.73），敏感性为 74.2%，特异性为 95.7%。careHPV 检测检测到 12 例（80%）组织学确诊的宫颈上皮内瘤变 2 级（CIN2）或更高级别病变，估计有 83.0%的特异性可检测到<CIN2。在一个具有挑战性的资源有限的环境中，干预措施最少，careHPV 检测的特异性很高，但敏感性可能低于目前在对照情况下使用的 HPV DNA 检测。
