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Chinese Journal of Antituberculosis ›› 2017, Vol. 39 ›› Issue (12): 1303-1308.doi: 10.3969/j.issn.1000-6621.2017.12.010

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Diagnostic value of high-sensitivity ELISA in active tuberculosis through detecting the secretion protein MPB64

ZHAO Bing*, HOU Ping, HUANG Jing, HE Wen-cong, OU Xi-chao, LIU Dong-xin, ZHAO Yan-lin   

  1. *National Tuberculosis Reference Laboratory, Chinese Center for Disease Control and Prevention, Beijing 102206, China
  • Received:2017-08-02 Revised:2018-01-10 Online:2017-12-10 Published:2018-01-11
  • Contact: ZHAO Yan-lin, Email: zhaoyanlin@chinatb.org

Abstract: Objective The aim of this study was to evaluate the value of high-sensitivity-ELISA test (HI-ELISA) in detecting Mycobacterium tuberculosis (MTB) in sputum, which is based on detecting the secretory protein MPB64. Methods Ninety-seven stored sputum specimens from suspected tuberculosis patients were subjected to cultivation in BACTEC MGIT 960 tubes, Xpert MTB/RIF test and HI-ELISA test, respectively, the results of HI-ELISA test and 960-liquid-culture test were compared to evaluate the diagnostic efficacy of HI-ELISA method. Results Among the 97 sputum specimens collected in this study, the positive rates of detecting MTB of 960-liquid-culture method and HI-ELISA method were 36.08% (35/97) and 32.99% (32/97) respectively. When compared with liquid-culture, the sensitivity of HI-ELISA was 88.57% (31/35), the specificity of HI-ELISA was 98.39% (61/62) and the overall coincidence rate was 94.85% (92/97). Of the 66 positives putum specimens using Xpert MTB/RIF, the positive rate of 960-liquid-culture method and HI-ELISA method in detecting MTB were 51.51% (34/66) and 48.48% (32/66), respectively; furthermore, compared with 960-liquid-culture,the sensitivity of HI-ELISA was 91.18% (31/34), the specificity was 96.88% (31/32) and the coincidence rate was 93.93% (62/66). Among the 31 negative sample stested by Xpert MTB/RIF, MTB was detected in only one sample by 960-liquid-culture method but HI-ELISA method failed to detect it, however, in the other 30 sputum samples, the results of HI-ELISA method were entirely consistent with the results of 960-liquid-culture method and the coincidence rate was 96.77% (30/31). Conclusion HI-ELISA assay was able to detecting viable MTB with high sensitivity and specificity, it was of high evaluate in diagnosis and treatment of active tuberculosis.

Key words: Mycobacterium tuberculosis, Secretory protein, MPB64, Enzyme-linked immunosorbentassay, Sensitivity and specificity, Diagnosis