Parra Manuel, Palomares José Carlos, Bernal Samuel, Sivianes Nieves, Pérez Luis, Pueyo Isabel, Almeida Carmen, Martín-Mazuelos Estrella
Laboratorio de Microbiología Molecular, Unidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario Valme, Sevilla, Spain.
Enferm Infecc Microbiol Clin. 2011 Jun-Jul;29(6):421-4. doi: 10.1016/j.eimc.2011.01.016. Epub 2011 May 4.
To evaluate the new automated system cobas 4800 CT/NG test for detection of Chlamydia trachomatis in urogenital specimens.
We analyzed 696 specimens (488 swabs from urethral or cervical specimens, and 208 urines) to detect C. trachomatis. The results of the cobas 4800 CT/NG test (c4800) were compared to those obtained with Cobas AMPLICOR CT/NG test (CAM). Discordant results were analyzed with a conventional PCR assay and microchip electrophoresis system in agarose gel, MultiNA.
We made two simultaneous analyses. In the first one, we compared the results obtained with swab specimens using the c4800 system and CAM. In this case, the sensitivity, the specificity, the positive and negative predictive values (PPV and NPV) were: 77.9%, 100%, 100% and 96% respectively. In the second one, we compared the results obtained for urine and its corresponding swab specimens on the c4800. The values obtained were: 100%, 98.9%, 92.9% and 100% respectively. The kappa values of these comparisons were: 0.857 for swab specimens on the c4800 and CAM, and 0.957 for urine versus swab specimens on the c4800.
The results obtained with c4800 system were completely comparable with those obtained with CAM. We also noted an excellent correlation with these results when we compared swab specimens with their urine samples in the c4800 system. Therefore this sample type could be used routinely to diagnose infections in men and women.
评估新型自动化系统 cobas 4800 CT/NG 检测泌尿生殖标本中沙眼衣原体的性能。
我们分析了696份标本（488份尿道或宫颈拭子标本以及208份尿液标本）以检测沙眼衣原体。将 cobas 4800 CT/NG 检测（c4800）的结果与 Cobas AMPLICOR CT/NG 检测（CAM）的结果进行比较。对不一致的结果采用常规聚合酶链反应检测及琼脂糖凝胶微芯片电泳系统（MultiNA）进行分析。
我们进行了两项同步分析。第一项分析中，我们比较了使用 c4800 系统和 CAM 检测拭子标本所得的结果。在此情况下，敏感性、特异性、阳性预测值和阴性预测值（PPV 和 NPV）分别为：77.9%、100%、100%和 96%。第二项分析中，我们比较了 c4800 上尿液及其相应拭子标本的检测结果。所得值分别为：100%、98.9%、92.9%和 100%。这些比较的kappa 值分别为：c4800 系统和 CAM 检测拭子标本时为 0.857，c4800 上尿液与拭子标本比较时为 0.957。
c4800 系统所得结果与 CAM 所得结果完全可比。当我们在 c4800 系统中将拭子标本与其尿液样本进行比较时，也注意到这些结果具有良好的相关性。因此，这种样本类型可常规用于诊断男性和女性的感染。
