Clinical Evaluation of Fully Automated Elecsys? Syphilis Assay for the Detection of Antibodies of Treponema pallidum

摘要

ObjectiveThe resurgence of syphilis in recent years has become a serious threat to the public health worldwide, and the serological detection of specific antibodies against Treponema pallidum (TP) remains the most reliable method for laboratory diagnosis of syphilis. The performance of the Elecsyssup?/sup Syphilis assay, a brand new electrochemiluminescene immunoassay (ECLIA), was assessed by large amounts of samples in this study. MethodsIn comparison with InTec assay, the Elecsyssup?/sup Syphilis assay was evaluated in 146 preselected samples from patients with syphilis, 1803 clinical routine samples, and 175 preselected samples from specific populations with reportedly increased rates of false-positive syphilis test results. Discrepancy samples must be investigated by Mikrogen Syphilis recomline assay. ResultsThere was an overall agreement of 99.58% between two assays (Kappa = 0.975). The sensitivity and specificity of the Elecsyssup?/sup Syphilis assay were 100.0% (95% CI, 96.8–100.0%) and 99.8% (95% CI, 99.5–100.0%), respectively. The Elecsys syphilis assay displays better sensitivity (100%), specificity (99.8%), PPV (98.7%), and NPV (100%) in 2124 samples enrolled, compared with the InTec assay. ConclusionConsidering the excellent ease of use and automation, high throughput, and its superior sensitivity, especially in primary syphilis, the Elecsyssup?/sup Syphilis assay could represent an outstanding choice for screening of syphilis in high-volume laboratories. However, more attention was still needed, or the results must be confirmed by other treponemal immunoassays. The new Elecsyssup?/sup Syphilis assay is applied to patients with malignant neoplasm or HIV infection.