比较 BD Viper 系统与 XTR 技术和 Gen-Probe APTIMA COMBO 2 检测试剂盒，使用 TIGRIS DTS 系统检测尿液标本中的沙眼衣原体和淋病奈瑟菌。

Comparison of the BD Viper System with XTR Technology to the Gen-Probe APTIMA COMBO 2 Assay using the TIGRIS DTS system for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens.

机构信息

Saskatchewan Disease Control Laboratory, Regina, Saskatchewan, Canada.

出版信息

Sex Transm Dis. 2012 Jul;39(7):514-7. doi: 10.1097/OLQ.0b013e31824f2f5b.

DOI:10.1097/OLQ.0b013e31824f2f5b

PMID:22706212

Abstract

BACKGROUND

Performances of the BD ProbeTec Chlamydia trachomatis (CT)/Neisseria Gonorrhoeae (GC) Q(x) Amplified DNA Assay reagents on a BD Viper System with XTR Technology and APTIMA COMBO 2 Assay reagents on a TIGRIS DTS platform, for detection of both CT and GC were compared.

METHODS

A total of 1018 first-void urine specimens were tested for the presence of CT and GC DNA using the 2 assays.

RESULTS

CT was detected in 143 specimens (14%). Eight specimens exhibited discordant results, and they were divided equally between the 2 assays. Based on the original results, the overall agreement for CT was 99.2%, with 97.1% and 99.5% in agreement with positive and negative specimens, respectively. Cohen's Kappa was 0.967. GC was detected in 27 specimens (2.6%). Two specimens exhibited discordant results, and they were divided equally between the 2 assays. Based on the original results, the overall agreement was 99.8%, with 96.2% and 99.9% in agreement for positive and negative specimens, respectively. Cohen's Kappa was 0.961.

CONCLUSIONS

There was a high level of agreement between the systems for both CT and GC detection.

摘要

背景

比较了 BD ProbeTec 沙眼衣原体（CT）/淋病奈瑟菌（GC）Q(x)扩增 DNA 检测试剂在具有 XTR 技术的 BD Viper 系统和 APTIMA COMBO 2 检测试剂在 TIGRIS DTS 平台上的性能，用于检测 CT 和 GC。

方法

使用这两种检测方法共检测了 1018 例首次尿液标本中 CT 和 GC DNA 的存在情况。

结果

143 例标本（14%）中检测到 CT。8 例标本的结果不一致，两种检测方法各有 4 例。基于原始结果，CT 的总体一致性为 99.2%，阳性和阴性标本的一致性分别为 97.1%和 99.5%。Cohen's Kappa 为 0.967。27 例标本（2.6%）中检测到 GC。两种检测方法各有 1 例标本结果不一致。基于原始结果，总体一致性为 99.8%，阳性和阴性标本的一致性分别为 96.2%和 99.9%。Cohen's Kappa 为 0.961。