评估 cobas 4800 CT/NG 检测沙眼衣原体和淋病奈瑟菌的试验。

Evaluation of the cobas 4800 CT/NG test for detecting Chlamydia trachomatis and Neisseria gonorrhoeae.

机构信息

Queensland Paediatric Infectious Diseases Laboratory, Sir Albert Sakzewski Virus Research Centre, Queensland Children's Medical Research Institute, Children's Health Service District, Queensland, Australia.

出版信息

Sex Transm Infect. 2010 Nov;86(6):470-3. doi: 10.1136/sti.2010.042812. Epub 2010 Aug 18.

DOI:10.1136/sti.2010.042812

PMID:20719957

Abstract

OBJECTIVES

To investigate the performance of the fully automated cobas 4800 CT/NG test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.

METHODS

The study was conducted using 900 clinical specimens (496 urine and 404 swab specimens) for C trachomatis testing, of which 498 specimens (318 urine and 180 swab specimens) were also tested for N gonorrhoeae. The results of the cobas 4800 CT/NG test were compared with those obtained from the Roche COBAS AMPLICOR CT/NG and COBAS TaqMan CT assays. N gonorrhoeae-positive specimens were further tested using in-house, real-time PCR assays. A panel of 223 Neisseria isolates was used to further investigate the performance of the cobas 4800 N gonorrhoeae assay.

RESULTS

For urine specimens, the sensitivity, specificity and negative and positive predictive values of the cobas 4800 CT/NG test were 94.5%, 99.5%, 98.8% and 97.7%, respectively, for C trachomatis, and 92.9%, 100%, 99.7% and 100%, respectively, for N gonorrhoeae. For swab specimens, the sensitivity, specificity and negative and positive predictive values were 92.0%, 100%, 99.5% and 100%, respectively, for C trachomatis, and 100%, 99.4%, 100% and 90.0%, respectively, for N gonorrhoeae. All N gonorrhoeae isolates were positive and all non-gonococcal Neisseria strains were negative by the cobas 4800 N gonorrhoeae assay.

CONCLUSIONS

The cobas 4800 CT/NG test is suitable for high through-put identification of C trachomatis and N gonorrhoeae infections.

摘要

目的

研究 cobas 4800 CT/NG 检测沙眼衣原体和淋病奈瑟菌的性能。

方法

本研究采用 900 例临床标本（496 例尿液和 404 例拭子标本）进行沙眼衣原体检测，其中 498 例（318 例尿液和 180 例拭子标本）同时进行淋病奈瑟菌检测。cobas 4800 CT/NG 检测结果与罗氏 COBAS AMPLICOR CT/NG 和 COBAS TaqMan CT 检测结果进行比较。对淋病奈瑟菌阳性标本进一步采用自建的实时 PCR 检测。使用 223 株奈瑟菌分离株进一步研究 cobas 4800 淋病奈瑟菌检测的性能。

结果

对于尿液标本，cobas 4800 CT/NG 检测沙眼衣原体的敏感性、特异性和阴性及阳性预测值分别为 94.5%、99.5%、98.8%和 97.7%，淋病奈瑟菌分别为 92.9%、100%、99.7%和 100%。对于拭子标本，cobas 4800 CT/NG 检测沙眼衣原体的敏感性、特异性和阴性及阳性预测值分别为 92.0%、100%、99.5%和 100%，淋病奈瑟菌分别为 100%、99.4%、100%和 90.0%。cobas 4800 淋病奈瑟菌检测对所有淋病奈瑟菌分离株均为阳性，对所有非淋病奈瑟菌菌株均为阴性。