ArticleFrontiers in cellular and infection microbiology2025
Evaluation of MAGLUMI syphilis test for accurate detection of syphilis antibodies in blood donors and suspected syphilis cases.
Article in Frontiers in cellular and infection microbiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Strengthening STD Screening Programs: Comprehensive Evaluation of High-Throughput Immunoassays for HIV and Syphilis Detection.Microorganisms · 2026Article
- Evaluation of the analytical performance of the MAGLUMI HEV IgM and IgG assays for automated detection of HEV antibodies and comparison with the microplate Wantai assay.Virology journal · 2026Article
- Analytical performance evaluation of MAGLUMI HBeAg and anti-HBe chemiluminescence immunoassays and comparison with the Abbott assays.Frontiers in cellular and infection microbiology · 2026Article
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The diagnosis of syphilis is critical to initiate treatment at an early stage and control the syphilis epidemic. The serological detection of treponemal antibodies is recommended in the reverse sequence screening algorithm as the first screening test. Study design: Serum samples from 5,081 unselected blood donors and 213 hospitalized patients were collected to evaluate the diagnostic specificity. To assess the diagnostic sensitivity, 487 positive samples were collected. 405 cross-interference samples were tested to evaluate analytical specificity. All samples were tested with the MAGLUMI Syphilis (Chemiluminescence immunoassay, CLIA) Test and the obtained results were compared with the Abbott ARCHITECT Syphilis TP reference test. Results: The diagnostic specificity and sensitivity of the MAGLUMI Syphilis (CLIA) Test was 99.96% (95% CI, 99.87-99.99%) and 100.00% (95% CI, 99.22-100.00%), respectively. The analytical specificity and the analytical sensitivity of the Test was 100.00% and 2.529 mIU/ml, respectively. No significant interference and cross-reactivity were observed in a number of potential factors. Conclusions: The performance of the MAGLUMI Syphilis (CLIA) Test makes it suited for identification of treponemal antibodies in screening populations as well as patients presenting with suspicion of syphilitic infection.
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