Clinica chimica acta; international journal of clinical chemistry · 2026
Diagnostic performance and interference analysis of a chemiluminescent H. pylori stool antigen assay stratified by 13C-urea breath test values in a multicenter study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Wang Zixia, Chen Xiaozhong, Lu Huiqiong, Deng Qianyun, Chen Liuqin, Meng Yue, Wang Beibei, Wang Lei, Fang Wei
Аннотация
BACKGROUND: Helicobacter pylori (H. pylori) infection remains a significant global health challenge, and accurate non-invasive diagnostic methods are essential for effective clinical management. This study aimed to evaluate the diagnostic performance of the MAGLUMI H. pylori antigen chemiluminescent immunoassay (CLIA) in a multicenter setting and compare its efficacy with the urea breath test (UBT), which served as the reference standard.
METHODS: A prospective multicenter study was conducted across four tertiary hospitals in China, enrolling 741 subjects. The diagnostic performance of the MAGLUMI H. pylori antigen CLIA was assessed using UBT as the reference standard, and influencing factors were explored through stratified analysis based on continuous UBT values.
RESULTS: The assay demonstrated high precision with a coefficient of variation (CV) of less than 5%. The diagnostic sensitivity was 94.59%, and specificity was 97.76%, with excellent agreement with UBT (Kappa = 0.9258). Stratified analysis revealed variations in diagnostic performance across different infection burden levels. Furthermore, the assay showed consistent performance across different stool consistencies and in clinical samples with abnormal stool findings, achieving an overall accuracy exceeding 91.30%, and complete agreement between CLIA and UBT was observed in these limited samples.
CONCLUSION: The MAGLUMI H. pylori antigen CLIA is a reliable, non-invasive diagnostic method with excellent clinical applicability and generalizability. Its strong performance across diverse clinical scenarios supports its potential as an effective tool for diagnosing H. pylori infection.
METHODS: A prospective multicenter study was conducted across four tertiary hospitals in China, enrolling 741 subjects. The diagnostic performance of the MAGLUMI H. pylori antigen CLIA was assessed using UBT as the reference standard, and influencing factors were explored through stratified analysis based on continuous UBT values.
RESULTS: The assay demonstrated high precision with a coefficient of variation (CV) of less than 5%. The diagnostic sensitivity was 94.59%, and specificity was 97.76%, with excellent agreement with UBT (Kappa = 0.9258). Stratified analysis revealed variations in diagnostic performance across different infection burden levels. Furthermore, the assay showed consistent performance across different stool consistencies and in clinical samples with abnormal stool findings, achieving an overall accuracy exceeding 91.30%, and complete agreement between CLIA and UBT was observed in these limited samples.
CONCLUSION: The MAGLUMI H. pylori antigen CLIA is a reliable, non-invasive diagnostic method with excellent clinical applicability and generalizability. Its strong performance across diverse clinical scenarios supports its potential as an effective tool for diagnosing H. pylori infection.