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Chinese Journal of Antituberculosis ›› 2022, Vol. 44 ›› Issue (9): 917-926.doi: 10.19982/j.issn.1000-6621.20220253

• Original Articles • Previous Articles     Next Articles

Efficacy and safety of recombinant Mycobacterium tuberculosis fusion proteins (EC) for the diagnosis of Mycobacterium tuberculosis infection: A system review

Cheng Xiao1,2,3,4, Chen Zhe1,2,3,4, Jiao Xuefeng1,2,3,4, Yang Nan1,2,3,4,5, Diao Sha1,2,3,4, Ni Xiaofeng1,2,3,4, Liu Zheng1,2,3,4,6, He Siyi1,2,3,4,5, Zeng Linan1,2,3,4, Wan Chaomin4,7, Kang Deying8, Wu Bin9, Ying Binwu10, Zhang Hui11, Zhao Rongsheng12, Zhang Lingli1,2,3,4()   

  1. 1Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, China
    2Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, China
    3NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, National Medical Products Administration, Chengdu 610041, China
    4Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu 610041, China
    5West China School of Pharmacy, Sichuan University, Chengdu 610041, China
    6West China School of Medicine, Sichuan University, Chengdu 610041, China
    7Department of Pediatrics, West China Second University Hospital, Sichuan University, Chengdu 610041, China
    8Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China
    9Department of Pharmacy, Ren Ji Hospital, Shanghai Jiaotong University, Shanghai 200127, China
    10Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, China
    11Department of Infection Management, West China Hospital, Sichuan University, Chengdu 610041, China
    12Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
  • Received:2022-07-10 Online:2022-09-10 Published:2022-09-05
  • Contact: Zhang Lingli E-mail:zhanglingli@scu.edu.cn

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Abstract:

Objective: Compared with purified protein derivative of tuberculin (TB-PPD), to systematically evaluate the efficacy and safety of recombinant Mycobacterium tuberculosis fusion protein (EC) in the diagnosis of Mycobacterium tuberculosis (MTB) infection. Methods: Data were searched from the clinical guideline database, biomedical literature database, official websites of health administrative departments and industry associations, and official websites of adverse reaction monitoring. The retrieval time is from the time of building the database to February 2022. English search terms were recombinant Mycobacterium tuberculosis fusion protein and CFP10/ESAT6; Chinese search terms were recombinant Mycobacterium tuberculosis fusion protein, Yika, and CFP10/ESAT6. Guidelines, consensuses, group standards, systematic reviews, and original studies on the efficacy and safety of recombinant Mycobacterium tuberculosis fusion protein (EC) and TB-PPD in diagnosing MTB infection were collected. Two investigators independently screened literature, extracted data, and assessed the risk of bias of included studies. Meta-analysis or descriptive analysis were used according to the size of heterogeneity. Results: Two guidelines, three expert consensus papers, and two group standards were included, and all presented that both recombinant Mycobacterium tuberculosis fusion protein (EC) and TB-PPD could be used for the detection of MTB infection and tuberculosis. One systematic review was included, and the results showed that the recombinant Mycobacterium tuberculosis fusion protein (EC) skin test recruited a total of 887 participants, with the sensitivity of 86.06% (95%CI: 82.39%-89.07%). The four original studies included were randomized controlled trials. The effectiveness meta-analysis showed that, regardless of the population, the sensitivity (89.3% vs. 90.4%) and negative likelihood ratio (0.177 vs. 0.220) of recombinant Mycobacterium tuberculosis fusion protein (EC) and TB-PPD were not significantly different. The specificity (85.5% vs. 47.3%), diagnostic odds ratio (42.238 vs. 8.040), positive likelihood ratio (6.048 vs. 1.710), positive predictive value (66.0% vs. 35.1%) and negative predictive value (96.2% vs. 94.0%) of recombinant Mycobacterium tuberculosis fusion protein (EC) were significantly better than those of TB-PPD. The safety results showed that the adverse events of recombinant Mycobacterium tuberculosis fusion protein (EC) and TB-PPD were just local itching and pain, and no serious adverse events occurred. Conclusion: Recombinant Mycobacterium tuberculosis fusion protein (EC) can be used for the diagnosis of MTB infection and auxiliary diagnosis of tuberculosis, and has better efficacy when compared with TB-PPD.

Key words: Recombinant Mycobacterium tuberculosis fusion protein (EC), Tuberculin test, Skin tests, Mycobacterium tuberculosis, Meta-analysis as topic

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