The analytical performance of the FDA-cleared AIX1000 automated RPR testing platform was evaluated in comparison to manual RPR card testing. Eight hundred thirty-three patient serum samples were analyzed, 87 samples were positive by the AIX1000, 108 were positive by the manual test method; overall agreement between methods was 96.5% (κ = 0.83). Cases were further classified by clinical and laboratory-based confirmation of disease, to which reactivity rates were compared, yielding sensitivities of 96.4% and 100%, and specificities of 99.2% and 96.8% for the automated and manual RPR methods, respectively. The difference in specificity between methods was statistically significant (P < 0.001).

Twenty-five of 29 samples with discordant results were reactive by manual testing (titers of 1:1 or 1:2); 21 of 25 patients with negative AIX100 results were identified to have histories of remote, treated syphilis. Overall, the AIX1000 platform demonstrated excellent agreement with the manual RPR method; discrepancies occurred with specimens at the threshold of reactivity.

与手动RPR卡测试相比，评估了FDA批准的AIX1000自动RPR测试平台的分析性能。分析了833个患者的血清样本，其中AIX1000的阳性样本为87个，手动测试方法的阳性为108个；方法之间的总体一致性为96.5％（κ= 0.83）。通过临床和实验室确诊疾病进一步对病例进行分类，将其与反应率进行比较，自动和手动RPR方法的敏感性分别为96.4％和100％，特异性分别为99.2％和96.8％。两种方法之间的特异性差异具有统计学意义（P <0.001）。

29个样本中有25个样本的结果不一致（通过1：1或1：2的滴定度）；在25例AIX100结果阴性的患者中，有21例被确定有远距离梅毒治疗史。总体而言，AIX1000平台与手动RPR方法表现出了极好的一致性。标本在反应性阈值处发生差异。