Comparison and evaluation of Abbott chemiluminescent microparticle immunoassay and ChIVD light‐initiated chemiluminescent assay in the detection of Treponema pallidum antibody

Abstract

Background Laboratory tests play an important role in the diagnosis of syphilis. This study aimed to compare and assess the performance of the Abbott chemiluminescent microparticle immunoassay (CMIA) and the ChIVD light‐initiated chemiluminescent assay (LICA) in the detection of Treponema pallidum ( TP ) antibody. Methods A total of 10 498 serum samples were detected with two assays, and the Treponema pallidum particle agglutination assay (TPPA) and recombinant immunoblot assay (RIBA) methods were used for confirmation. The sensitivity, specificity, positive predictive value, and negative predictive value of the Abbott CMIA and ChIVD LICA were calculated. The coincidence rate between two assays was also evaluated. The causes of false positive and false negative of two assays were studied. Results For the Abbott CMIA and ChIVD LICA, the sensitivity was 94.44% and 98.15%, the specificity was 99.89% and 99.81%, the positive predictive value was 93.29% and 88.83%, and the negative predictive value was 99.91% and 99.97%, respectively. The coincidence rate between Abbott CMIA and ChIVD LICA was 99.26%, and κ value was .790. The disease of infertility, hypertensive disease, liver disease, and cancer were the common causes of false positive in both assays, while infertility was also the main reason lead to false negative. Conclusion Our results demonstrated that the Abbott CMIA and ChIVD LICA generally had high sensitivity and specificity and therefore may be suitable for the detection of TP antibody and screening for syphilis.

Assessment of recombinant antigens Tp0100 and Tp1016 of Treponema pallidum for serological diagnosis of syphilis

“…The LICA Syphilis TP, a commercial available CIA kit, is highly sensitive and specific and could be used for T. pallidum antibody detection and syphilis screening. 24 Using the clinical diagnosis as the gold standard, the LICA Syphilis TP revealed an overall higher sensitivity (97.6%), especially in early syphilis stage, than the Tp0100‐based ELISA (95.6%) but an overall lower specificity (96.2%) than the Tp0100‐based ELISA (98.1%). The possible explanation for these results is that a combination of multiple treponemal antigens and the total antibody (IgG and IgM) detection in the LICA Syphilis TP may enhance the sensitivity than a single treponemal antigen and IgG antibody detection in the Tp0100‐based ELISA.…”

“…20173401251), which uses double‐antigen sandwich immunoassay method based on recombinant T. pallidum antigens TpN15, TpN17, and TpN47 for qualitative detection of the coresponding both IgG and IgM antibodies. 24 In this study, the LICA Syphilis TP test was performed to screen all the serum samples described above on a fully automated system Chemclin @ 1500 analyzer (ChIVD, Beijing, China) according to the manufacturer's instructions. The chemiluminescent reaction was measured in relative light units (RLUs), with the RLU/cutoff (S/CO) radio ≥1.0 indicating a positive result, and the S/CO radio <1 indicating a negative result.…”

“…The LICA Syphilis TP (ChIVD) is a commercial available CIA kit (China Medical Device Registration Approval No. 20173401251), which uses double‐antigen sandwich immunoassay method based on recombinant T. pallidum antigens TpN15, TpN17, and TpN47 for qualitative detection of the coresponding both IgG and IgM antibodies 24 . In this study, the LICA Syphilis TP test was performed to screen all the serum samples described above on a fully automated system Chemclin @ 1500 analyzer (ChIVD, Beijing, China) according to the manufacturer's instructions.…”

A Simple and Rapid Light-Initiated Chemiluminescence Assay for Quantitation of <b><i>Artemisia</i></b>-Specific Immunoglobulin E

“…Nowadays, LICA has been used in many studies, such as detection of hepatitis C virus antibodies [6], total testosterone [7], estradiol [8], human cytomegalovirus immunoglobulin G (IgG) antibodies [9], allergen-specific IgG4 antibodies [10], and Treponema pallidum antibodies [11]. Apart from the above, our team had successfully applied LICA to the detection of food allergen-specific immunoglobulin E (sIgE), such as egg-sIgE [12] and cow's milk-sIgE [13].…”

“…To the best of our knowledge, there has been no report on the LICA-based detection of inhaled allergen-sIgE till date [6][7][8][9][10][11][12][13]. Moreover, the Artemisia pollen is the most widespread outdoor allergen throughout China, which can cause allergic rhinitis, asthma, and/or both [14].…”