Evaluation of the Elecsys syphilis immunoassay for routine screening of serum samples in China.

We compared the performance of the Roche Diagnostics Elecsys immunoassay for the detection of Treponema pallidum specific antibodies in patient serum samples with that of the Abbott Laboratories Architect chemiluminescent microparticle immunoassay and the InTec and KHB enzyme-linked immunosorbent assays, which are commonly used in China. We tested 13,767 serum samples collected from 13 independent laboratories throughout China, which included samples from 999 previously confirmed syphilis cases and 158 'borderline' samples previously identified using the Architect, InTec, and KHB tests. The Mikrogen Syphilis Immunoblot was used to confirm positive test results. The consistency between the four different assays was 100%. The sensitivity of Elecsys immunoassay was 100% versus 98.26% for Architect, 99.11% for InTec; and 98.56% for KHB. The specificity of the Elecsys immunoassay was 99.81% versus 99.74% for Architect; 99.93% versus 99.80% for InTec; and 99.85% versus 99.77% for KHB. For borderline samples, the Elecsys immunoassay yielded no false-negative results and fewer false-positive results, compared to the other tests. Considering the ease-of-use, automation, high speed, and high throughput capacity of the Elecsys assay, the higher sensitivity and specificity indicate it is superior for routine screening of serum samples for syphilis diagnosis.