Evaluation of a new chemiluminescence immunoassay for diagnosis of syphilis

Abstract Objective To assess the sensitivity, specificity, and feasibility of a new chemiluminescence immunoassay (CLIA) in the diagnosis of syphilis. Methods At 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). Results There 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. Conclusions CLIA 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.