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已发表论文
OMP22-PCR 联合 SAT 诊断中国新疆布鲁菌病的诊断准确性研究
Authors Yun M, Chen J, Zhou Y, Wei C, Zhang K, Zhang C, Zhu C , Xie S
Received 10 November 2025
Accepted for publication 27 January 2026
Published 2 February 2026 Volume 2026:19 575518
DOI https://doi.org/10.2147/IDR.S575518
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Hazrat Bilal
Minghui Yun,1,2,* Jing Chen,3,4,* Yang Zhou,1,2,* Chao Wei,1,2 Kaiting Zhang,1,2 Chanjuan Zhang,1,2 Chuanlong Zhu,5 Songsong Xie1,2
1NHC Key Laboratory of Prevention and Treatment of Central Asia High Incidence Diseases(Co-Construction), The First Affiliated Hospital of Shihezi University, The Clinical Research Center for Infectious Diseases of Xinjiang Production and Construction Corps, Shihezi, 832099, People’s Republic of China; 2State Key Laboratory for Diagnosis and Treatment of Severe Zoonotic Infectious Diseases, Wuhan, 430000, People’s Republic of China; 3Nanjing Medical University, Nanjing, 210000, People’s Republic of China; 4The Second People’ s Hospital of Yining, Yining, Xinjiang, 835000, People’s Republic of China; 5Department of Infectious Diseases, the First Affiliated Hospital with Nanjing Medical University, Nanjing, 210000, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Songsong Xie, Email xss2024@126.com Chuanlong Zhu, Email zhuchuanlong@jsph.org.cn
Background: The standard tube agglutination test (SAT) is a cornerstone for brucellosis diagnosis but has inherent limitations, including false negatives in early and chronic infections and false positives due to cross-reactivity. To overcome these drawbacks, molecular detection targeting the highly conserved Brucella outer membrane protein 22 (OMP22) gene presents a promising solution. This study aimed to evaluate the diagnostic value of OMP22-PCR and its efficacy when combined with SAT.
Methods: From January 2023 to May 2024, serum samples from 62 culture-confirmed brucellosis patients and 25 controls were analyzed using OMP22-PCR and SAT. Diagnostic performance was compared, discordant results were analyzed, and OMP22 detection was extended to 20 clinical isolates, 20 urine samples, and 2 cerebrospinal fluid (CSF) samples.
Results: OMP22-PCR demonstrated a sensitivity of 93.5% and specificity of 92.0%, which was comparable to SAT (96.8% and 88.0%, respectively; both P > 0.05). Crucially, the combined detection approach achieved a significantly higher specificity of 100% and a positive predictive value of 100%, and a significantly larger area under the ROC curve (AUC) than either test alone (P < 0.05), all while maintaining a high sensitivity of 96.8%. Analysis of discordant samples revealed their complementary nature: SAT-positive/OMP22-PCR-negative samples were primarily from chronic-stage patients, whereas SAT-negative/OMP22-PCR-positive samples were from early-stage patients. Furthermore, OMP22 was detected in all clinical isolates (100%), 70.0% of urine samples, and both CSF samples (100%).
Conclusion: The combination of OMP22-PCR and SAT effectively compensates for the limitations of each method alone, significantly enhancing diagnostic accuracy. The strong performance of OMP22-PCR in non-blood samples further underscores its value as a complementary tool, thereby supporting the development of more comprehensive diagnostic strategies for brucellosis.
Keywords: brucellosis, OMP22, PCR, standard tube agglutination test, diagnostic efficacy
1NHC Key Laboratory of Prevention and Treatment of Central Asia High Incidence Diseases(Co-Construction), The First Affiliated Hospital of Shihezi University, The Clinical Research Center for Infectious Diseases of Xinjiang Production and Construction Corps, Shihezi, 832099, People’s Republic of China; 2State Key Laboratory for Diagnosis and Treatment of Severe Zoonotic Infectious Diseases, Wuhan, 430000, People’s Republic of China; 3Nanjing Medical University, Nanjing, 210000, People’s Republic of China; 4The Second People’ s Hospital of Yining, Yining, Xinjiang, 835000, People’s Republic of China; 5Department of Infectious Diseases, the First Affiliated Hospital with Nanjing Medical University, Nanjing, 210000, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Songsong Xie, Email xss2024@126.com Chuanlong Zhu, Email zhuchuanlong@jsph.org.cn
Background: The standard tube agglutination test (SAT) is a cornerstone for brucellosis diagnosis but has inherent limitations, including false negatives in early and chronic infections and false positives due to cross-reactivity. To overcome these drawbacks, molecular detection targeting the highly conserved Brucella outer membrane protein 22 (OMP22) gene presents a promising solution. This study aimed to evaluate the diagnostic value of OMP22-PCR and its efficacy when combined with SAT.
Methods: From January 2023 to May 2024, serum samples from 62 culture-confirmed brucellosis patients and 25 controls were analyzed using OMP22-PCR and SAT. Diagnostic performance was compared, discordant results were analyzed, and OMP22 detection was extended to 20 clinical isolates, 20 urine samples, and 2 cerebrospinal fluid (CSF) samples.
Results: OMP22-PCR demonstrated a sensitivity of 93.5% and specificity of 92.0%, which was comparable to SAT (96.8% and 88.0%, respectively; both P > 0.05). Crucially, the combined detection approach achieved a significantly higher specificity of 100% and a positive predictive value of 100%, and a significantly larger area under the ROC curve (AUC) than either test alone (P < 0.05), all while maintaining a high sensitivity of 96.8%. Analysis of discordant samples revealed their complementary nature: SAT-positive/OMP22-PCR-negative samples were primarily from chronic-stage patients, whereas SAT-negative/OMP22-PCR-positive samples were from early-stage patients. Furthermore, OMP22 was detected in all clinical isolates (100%), 70.0% of urine samples, and both CSF samples (100%).
Conclusion: The combination of OMP22-PCR and SAT effectively compensates for the limitations of each method alone, significantly enhancing diagnostic accuracy. The strong performance of OMP22-PCR in non-blood samples further underscores its value as a complementary tool, thereby supporting the development of more comprehensive diagnostic strategies for brucellosis.
Keywords: brucellosis, OMP22, PCR, standard tube agglutination test, diagnostic efficacy