Effectiveness of a simple rapid human papillomavirus DNA test in rural Nigeria
Effectiveness of a simple rapid human papillomavirus DNA test in rural Nigeria
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DOI：
10.1002/ijc.27563
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发表时间：
2012-12-15
影响因子：
6.4
通讯作者：
Schiffman, Mark
中科院分区：
文献类型：
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作者：
Gage, Julia C.;Ajenifuja, Kayode O.;Schiffman, Mark
新的人乳头瘤病毒（HPV）DNA检测在低资源环境中的成功（careHPV（TM）检测; QIAGEN盖瑟斯堡公司，盖瑟斯堡，马里兰州）要求由实验室经验有限的人员操作时具有良好的测试性能。我们评估了尼日利亚一个大村庄的宫颈筛查项目中careHPV检测的可转移性、可靠性和准确性。对接受阴道镜检查的筛查阳性（n = 345）和筛查阴性（n = 42）女性进行了CareHPV检测（68.3%的转诊）。在美国处理和读取异常出现区域的活组织检查。阴道镜检查前立即采集的CareHPV标本由两名没有实验室经验的中学毕业生处理多达四次（在现场），并接受了本研究的培训。具体来说，QIAGEN盖瑟斯堡培训了一位没有实验室经验的美国研究人员，他培训了第一位当地技术人员，反过来又培训了第二位。将剩余标本送往美国进行MY 09/MY 11 PCR检测，检测13种致癌基因型（HPV 16、18、31、33、35、39、45、51、52、56、58、59、68）和HPV 66（包括在careHPV中）。治疗前后的一致率为98.8%（？= 0.97）和98.9%（kappa = 0.97），而评定者间一致性为96.3%（kappa = 0.90）。与MY 09/MY 11 PCR（病毒学参考标准）的一致性为89.3%（kappa = 0.73），灵敏度为74.2%，特异性为95.7%。careHPV检测检出15例经组织学证实的宫颈上皮内瘤变2级（CIN 2）或更严重病变中的12例（80%），估计特异性为83.0%。
Success of the new human papillomavirus (HPV) DNA test for low-resource settings (careHPV (TM) 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% (? = 0.97) and 98.9% (kappa = 0.97) for Technicians 1 and 2, respectively, while inter-rater agreement was 96.3% (kappa = 0.90). Agreement with MY09/MY11 PCR (virologic reference standard) was 89.3% (kappa = 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