BD Onclarity HPV 与 digene HC2 High-Risk HPV DNA 检测和 Roche Cobas 4800 HPV 检测用于检测日本高危型人乳头瘤病毒的比较研究。

Comparison Study of BD Onclarity HPV With digene HC2 High-Risk HPV DNA Test and Roche Cobas 4800 HPV for Detecting High-Risk Human Papillomavirus in Japan.

机构信息

Department of Obstetrics and Gynecology, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.

出版信息

Am J Clin Pathol. 2019 Feb 4;151(3):263-269. doi: 10.1093/ajcp/aqy124.

DOI:10.1093/ajcp/aqy124

PMID:30260388

Abstract

OBJECTIVES

To evaluate the clinical performance of novel detection kits for 14 high-risk human papillomavirus (hrHPV) types with the BD Onclarity HPV Assay (Onclarity; Becton Dickinson, Sparks, MD).

METHODS

Two cervical specimens from 144 women were obtained and placed in BD SurePath Collection Vials. The first specimen was used for cervical cytology and digene HC2 High-Risk HPV DNA Test (HC2; Qiagen, Germantown, MD), and the second specimen was used for Onclarity and Roche Cobas 4800 HPV (Cobas; Roche Molecular Systems, Pleasanton, CA). Other HPV genotyping kits were used for specimens identified as positive by Onclarity or Cobas.

RESULTS

Fifty-three of 144 specimens were positive by Onclarity. Overall agreement rates of Onclarity with HC2 and Cobas were 93.8% and 94.4%, respectively. The sensitivity and specificity for cervical intraepithelial neoplasia type 2 or higher of Onclarity were similar to HC2 and Cobas.

CONCLUSION

The results showed that the clinical performance of Onclarity was equivalent to HC2 and Cobas.

摘要

目的

评估新型 14 种高危型人乳头瘤病毒（hrHPV）检测试剂盒（BD Onclarity HPV 检测试剂盒（Onclarity）；Becton Dickinson，Sparks，MD）的临床性能。

方法

采集 144 名女性的两个宫颈标本，分别置于 BD SurePath 采集管中。第一个标本用于宫颈细胞学检查和 digene HC2 高危型 HPV DNA 检测（HC2；Qiagen，Germantown，MD），第二个标本用于 Onclarity 和 Roche Cobas 4800 HPV 检测（Cobas；Roche Molecular Systems，Pleasanton，CA）。对于 Onclarity 或 Cobas 检测阳性的标本，使用其他 HPV 基因分型试剂盒进行检测。