McLendon Clinical Laboratories, University of North Carolina Hospitals, Chapel Hill, North Carolina, USA.
Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
J Clin Microbiol. 2018 Jul 26;56(8). doi: 10.1128/JCM.00214-18. Print 2018 Aug.
The analytical performance of the AIX1000 system, a fully automated and recently FDA-cleared rapid plasma reagin (RPR) system, was evaluated by comparison to a manual RPR test in a traditional syphilis testing algorithm. A total of 1,028 consecutive serum samples submitted for syphilis testing to the University of North Carolina Hospitals Clinical Immunology Laboratory were tested per each manufacturer's instructions. Among those samples, 996 were nonreactive and 20 were reactive using both the ASI RPR card system and the AIX1000 system. Of the 12 discrepant specimens, 11 were AIX1000 reactive and ASI card nonreactive whereas 1 specimen was ASI card reactive and AIX1000 nonreactive. The sensitivity and specificity of the manual ASI card were 76.0% and 99.8%, respectively, while the sensitivity and specificity of the AIX100 were 100.0% and 99.4%, respectively (sensitivity = 0.03). Among the 20 concordant reactive specimens, 68.4% of the titers agreed within ±1 dilution between methods. Reproducibility testing of the AIX1000 system demonstrated qualitative and semiquantitative (within ±1 dilution) agreement between specimens tested on different days of 96.0% and 76.0%, respectively, and 100.0% agreement between replicates within the same run. One of 24 samples analyzed under other disease conditions was reactive on both the AIX1000 system and the ASI card. Overall, the fully automated AIX1000 system demonstrated significantly enhanced sensitivity and specificity similar to that of the manual ASI RPR card test, making the AIX1000 system suitable for the laboratory diagnosis of syphilis in a clinical laboratory setting.
该 AIX1000 系统的分析性能，完全自动化和最近的 FDA 清除快速血浆反应素（RPR）系统，进行评估比较，以手动 RPR 测试在传统的梅毒检测算法。共有 1028 连续血清样本提交梅毒检测到北卡罗来纳大学医院临床免疫学实验室进行了测试，每个制造商的指令。在这些样本中，996 是非反应性和 20 是使用 ASI RPR 卡系统和 AIX1000 系统反应性。在 12 个不一致的标本，11 个是 AIX1000 反应性和 ASI 卡非反应性，而 1 标本是 ASI 卡反应性和 AIX1000 非反应性。手动 ASI 卡的灵敏度和特异性分别为 76.0％和 99.8％，而 AIX100 的灵敏度和特异性分别为 100.0％和 99.4％（灵敏度= 0.03）。在 20 个一致的反应性标本中，68.4％的滴度同意在方法之间的 ±1 稀释。AIX1000 系统的重复性测试表明，在不同的天 96.0％和 76.0％之间分别测试的标本的定性和半定量（在 ±1 稀释）协议，和 100.0％的协议之间的复制品在同一运行。在其他疾病条件下分析的 24 个样本之一，在 AIX1000 系统和 ASI 卡上都是反应性的。总体而言，全自动 AIX1000 系统表现出显著提高的灵敏度和特异性，类似于手动 ASI RPR 卡试验，使 AIX1000 系统适用于梅毒的实验室诊断在临床实验室环境。
