SNIPER：一种在中国贵州地区针对女性进行人乳头瘤病毒检测的新方法。

SNIPER: a novel assay for human papillomavirus testing among women in Guizhou, China.

机构信息

Preventive Oncology International, Inc, Cleveland Heights, Ohio 44118, USA.

出版信息

Int J Gynecol Cancer. 2010 Aug;20(6):1006-10. doi: 10.1111/IGC.0b013e3181e73092.

DOI:10.1111/IGC.0b013e3181e73092

PMID:20683409

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2971549/

Abstract

OBJECTIVE

Clinically validate the SNIPER human papillomavirus (HPV) DNA assay for the detection of cervical intraepithelial neoplasia (CIN)2 or higher and CIN2 or higher in a prospective cross-sectional screening study in Guizhou Province, China.

METHODS

Between March and April, 2008, 1000 nonpregnant women aged 30 or older were recruited in Guizhou Province, China. Women positive by SNIPER or cytological examination were requested to return for follow-up. A biopsy of all colposcopically detected abnormalities was performed by quadrant. In normal quadrants, biopsies were obtained at the squamocolumnar junction (2-, 4-, 8-, and 10-o'clock positions depending on the quadrant). Samples were placed in 2 mL of saline solution and maintained between 2 degrees C and 30 degrees C for up to 1 week. One milliliter of this suspension was then prepared and tested. For polymerase chain reaction amplification, a pool of HPV primers was designed to amplify HPV DNA from 13 high-risk-HPV genotypes (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68). Test characteristics were calculated according to standard definitions.

RESULTS

One thousand women were screened; 175 tested HPV positive, 36 women tested negative but had positive Papanicolaou test results. All but 21 (90%) returned for follow-up. Median age and proportions having CIN2 or higher and CIN3 or higher differed by HPV status. Twenty-five women had CIN2 or higher and 16 had CIN3 or higher. The SNIPER assay was 93.3% and 94% sensitive and 86% and 85% specific for the detection of CIN2 or higher and CIN3 or higher, respectively. The positive predictive value was 17.4 % and 9.9% for CIN2 or higher and CIN3 or higher, respectively. Negative predictive value approached 100% for CIN2 or higher and CIN3 or higher.

CONCLUSION

The SNIPER assay is functionally competitive and in terms of cost holds an advantage over Hybrid Capture 2 in a Chinese healthcare market, and potentially others, around the world.

摘要

目的

在中国贵州省进行的一项前瞻性横断面筛查研究中，对 SNIPER 人乳头瘤病毒（HPV）DNA 检测用于检测宫颈上皮内瘤变（CIN）2 或更高级别和 CIN2 或更高级别的情况进行临床验证。

方法

2008 年 3 月至 4 月，在中国贵州省招募了 1000 名年龄在 30 岁及以上的非孕妇。SNIPER 或细胞学检查阳性的女性被要求返回进行随访。对所有阴道镜检查发现的异常进行活检。在正常象限，在根据象限而定的 2、4、8 和 10 点钟位置取宫颈鳞柱状交界处（squamocolumnar junction）的活检。将样本置于 2 mL 盐水中，并在 2 摄氏度至 30 摄氏度之间保存，最长可达 1 周。然后准备并测试 1 毫升该悬浮液。用于聚合酶链反应扩增，设计了一组 HPV 引物，以从 13 种高危 HPV 基因型（类型 16、18、31、33、35、39、45、51、52、56、58、59 和 68）中扩增 HPV DNA。根据标准定义计算测试特征。

结果

对 1000 名女性进行了筛查；175 名女性 HPV 检测阳性，36 名女性 HPV 检测阴性但巴氏涂片检查结果阳性。除 21 名（90%）女性外，其余女性均返回进行随访。HPV 状态不同，中位年龄和 CIN2 或更高级别和 CIN3 或更高级别的比例也不同。25 名女性患有 CIN2 或更高级别，16 名女性患有 CIN3 或更高级别。SNIPER 检测对 CIN2 或更高级别和 CIN3 或更高级别的敏感性分别为 93.3%和 94%，特异性分别为 86%和 85%。CIN2 或更高级别的阳性预测值为 17.4%，CIN3 或更高级别的阳性预测值为 9.9%。CIN2 或更高级别和 CIN3 或更高级别的阴性预测值均接近 100%。