Evaluation of a new chemiluminescence immunoassay for diagnosis of syphilis

Abstract

ObjectiveTo assess the sensitivity, specificity, and feasibility of a new chemiluminescence immunoassay (CLIA) in the diagnosis of syphilis.MethodsAt first, a retrospective study was conducted, using 135 documented cases of syphilis and 30 potentially interfering samples and 80 normal sera. A prospective study was also performed by testing 2, 071 unselected samples for routine screening for syphilis. CLIA was compared with a nontreponemal test (TRUST) and a treponemal test (TPPA).ResultsThere was an agreement of 100% between CLIA and TPPA in the respective study. The percentage of agreement among the 245 sera tested was 100.0%. Compared with TPPA, the specificity of CLIA was 99.9% (1817/1819), the sensitivity of CLIA was 100.0% (244/244) in the prospective study. CLIA showed 99.5% agreement with TPPA by testing 2, 071 unselected samples. And CLIA seemed to be more sensitive than TPPA in detecting the samples of primary syphilis.ConclusionsCLIA is easy to perform and the indicator results are objective and unequivocal. It may be suitable for large-scale screening as a treponemal test substituted for TPPA.

Performance of Treponema pallidum recombinant proteins in the serological diagnosis of syphilis

“…Several recombinant and native T. pallidum-proteins have already been tested as antigens in diagnostic tests for syphilis. Promising results were found using various diagnostic platforms [15][16][17][18][19][20][21][22][23][24][25]. However, there is no consensus on which antigens have the best serodiagnostic performance for syphilis.…”

Performance Evaluation of CLIA for Treponema Pallidum Specific Antibodies Detection in Comparison with ELISA

“…ELISA, an important assay of EIAs, is considered as a traditional assay to detect serum T. pallidum specific antibodies, and especially based on its high sensitivity and specificity, it has been widely used since 1980s . CLIA, a newly developed method, can allow for rapid detection of T. pallidum specific antibodies on random‐access analyzers with higher precision, sensitivity and specificity . And TPPA, as the confirmatory test, can ensure its sensitivity and specificity for diagnosing syphilis infection by using T. pallidum (Nichols Strain) as antigen.…”

“…With the development of methodology, chemiluminescence assay (CLIA) has come into being. CLIA can automatically and quickly detect serum T. pallidum specific antibodies with high sensitivity and specificity for syphilis diagnosis . Previous studies mainly evaluated the diagnostic efficiency of EIA in T. pallidum specific antibodies detection .…”

Evaluation of the HISCL Anti-Treponema pallidum Assay as a Screening Test for Syphilis

“…In particular, 32 samples were from patients with primary syphilis, 21 were from patients with secondary syphilis, 12 were from patients with tertiary syphilis, 81 were from patients with latent syphilis, and 154 were from patients with unknown syphilis stages. Also included were 704 syphilis-negative fresh plasma samples tested by the commercially available and routinely used Lumipulse G TP-N and 48 preselected samples from patients with diseases or conditions known to potentially cross-react with syphilis assays to yield false-positive results (potentially interfering samples), including 5 hemolytic samples, 5 samples with high bilirubin, 10 samples from patients with autoimmune diseases (5 from patients with rheumatoid arthritis and 5 from patients with systemic lupus erythematosus), 24 30 samples with signal-to-cutoff (s/co) ratios ranging from 0.75 to 3.0, determined using the InTec enzyme-linked immunosorbent assay (ELISA) kit for TP, were collected as "borderline" samples. All were leftover plasma samples from routine requests and were anonymized for further analysis.…”