Los Angeles County Department of Public Health, Los Angeles, California, USA.
J Clin Microbiol. 2011 Apr;49(4):1347-53. doi: 10.1128/JCM.01634-10. Epub 2011 Feb 9.
We evaluated the analytical, work flow, and clinical performance of the Versant CT/GC DNA 1.0 assay (Versant CT/GC assay, where "CT" represents Chlamydia trachomatis and "GC" represents Neisseria gonorrhoeae). The assay simultaneously detects Chlamydia trachomatis and Neisseria gonorrhoeae in swab and first-catch urine (FCU) specimens. The limit of detection (LoD) was determined to be 342 copies/ml for C. trachomatis and 137 copies/ml for GC. The Versant CT/GC assay detected 15 C. trachomatis serovars and 46 GC strains. The Versant CT/GC assay demonstrated no cross-reactivity with 136 potentially cross-reacting organisms. Clinical concordance of the Versant CT/GC assay to the Aptima Combo 2 (AC2) assay from Gen-Probe was demonstrated using 1,129 patient specimens, including 589 urine and 540 swab specimens. Discrepant specimens were subjected to DNA sequencing to identify the presence of amplified targets and to identify false-positive and false-negative results. Overall percent agreement was greater than 98%. Positive and negative percent agreements for detection of C. trachomatis were 94.4% and 99.1%, respectively, in urine specimens and 95.8% and 99.8%, respectively, in swab specimens. Positive percent agreement for the detection of N. gonorrhoeae was 100% in both urine and swab specimens, and negative percent agreements were 99.6% and 99% in urine and swab specimens, respectively. In conclusion, the performance of the Versant CT/GC assay was comparable to that of the AC2 assay. The Versant CT/GC assay can be recommended for the detection of C. trachomatis and N. gonorrhoeae in swab and urine specimens of symptomatic and asymptomatic individuals.
我们评估了 Versant CT/GC DNA 1.0 检测（Versant CT/GC 检测，其中“CT”代表沙眼衣原体，“GC”代表淋病奈瑟菌）的分析、工作流程和临床性能。该检测同时检测拭子和首段尿（FCU）标本中的沙眼衣原体和淋病奈瑟菌。检测的最低检测限（LoD）为沙眼衣原体 342 拷贝/ml，淋病奈瑟菌 137 拷贝/ml。Versant CT/GC 检测到 15 种沙眼衣原体血清型和 46 种淋病奈瑟菌菌株。Versant CT/GC 检测与 136 种潜在交叉反应的生物体无交叉反应。使用包括 589 份尿液和 540 份拭子标本在内的 1129 份患者标本，验证了 Versant CT/GC 检测与 Gen-Probe 的 Aptima Combo 2（AC2）检测的临床一致性。对有差异的标本进行 DNA 测序，以确定扩增靶标和识别假阳性和假阴性结果的存在。总体符合率大于 98%。在尿液标本中，检测沙眼衣原体的阳性和阴性符合率分别为 94.4%和 99.1%，在拭子标本中，分别为 95.8%和 99.8%。在尿液和拭子标本中，检测淋病奈瑟菌的阳性符合率均为 100%，阴性符合率分别为 99.6%和 99%。总之，Versant CT/GC 检测的性能与 AC2 检测相当。该 Versant CT/GC 检测可推荐用于检测有症状和无症状个体的拭子和尿液标本中的沙眼衣原体和淋病奈瑟菌。
