Fang Wei, Zhang Yun, Shi Min, Liao Yuqin, Peng Lanhuan, Zhong Hailin, Yin Jun, Mo Taoran, Li Heng, Fang Zhonggang
Laboratory Medicine, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Research & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe), Shenzhen, China.
Front Cell Infect Microbiol. 2025 May 15;15:1578060. doi: 10.3389/fcimb.2025.1578060. eCollection 2025.
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.
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.
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.
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.
梅毒的诊断对于早期开始治疗和控制梅毒流行至关重要。在反向序列筛查算法中，推荐将梅毒螺旋体抗体的血清学检测作为首次筛查试验。
收集了5081名未经选择的献血者和213名住院患者的血清样本以评估诊断特异性。为评估诊断敏感性，收集了487份阳性样本。检测了405份交叉干扰样本以评估分析特异性。所有样本均采用迈瑞梅毒（化学发光免疫分析法，CLIA）检测进行检测，并将所得结果与雅培ARCHITECT梅毒螺旋体（TP）参考检测进行比较。
迈瑞梅毒（CLIA）检测的诊断特异性和敏感性分别为99.96%（95%可信区间，99.87 - 99.99%）和100.00%（95%可信区间，99.22 - 100.00%）。该检测的分析特异性和分析敏感性分别为100.00%和2.529 mIU/ml。在多个潜在因素中未观察到明显干扰和交叉反应。
迈瑞梅毒（CLIA）检测的性能使其适用于筛查人群以及疑似梅毒感染患者中梅毒螺旋体抗体的鉴定。
