Ultrasensitive enzyme-linked immunosorbent assay for the detection of MPT64 secretory antigen to evaluate Mycobacterium tuberculosis viability in sputum

International Journal of Infectious Diseases

Rikiya Takeuchi¹  Keita Takeda²  Jun Miyakoshi³  Mikio Takamori³  Mari Iguchi³  Eiji Hayashi⁴  Yuriko Igarashi⁵  Masatoshi Tachibana⁵  Koichi Yano⁶  Kengo Murata⁶  Miyake Yamamoto⁶  Yu Sato⁶  Kazunari Nakaishi⁷  Mariko Komatsu⁷  Satoshi Watabe⁷  Kensuke Ito⁸  Tetsuya Kashiyama⁸  Satoshi Mitarai⁹  Kentaro Sakashita^1,10  Masahiro Ono^1,10  Masahiro Kawashima^1,10  Akio Aono^1,10  Akihiko Wada^1,10  Akiko Takaki^1,10  Akira Yamane^1,10  Hideaki Nagai^1,10  Kinuyo Chikamatsu^1,10 

[1] Department of Basic Mycobacteriology, Graduate School of Biomedical Science, Nagasaki University, Nagasaki, Japan;Department of Internal Medicine, Tokyo Metropolitan Matsuzawa Hospital, Tokyo, Japan;Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan;Department of Respiratory Medicine, National Hospital Organization Tokyo National Hospital, Tokyo, Japan;Department of Basic Mycobacteriology, Graduate School of Biomedical Science, Nagasaki University, Nagasaki, Japan;Department of Internal Medicine, Tokyo Metropolitan Matsuzawa Hospital, Tokyo, Japan;Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan;Department of Research and Development, TAUNS Laboratories Inc., Shizuoka, Japan;Department of Respiratory Medicine, National Hospital Organization Tokyo National Hospital, Tokyo, Japan;Department of Respiratory Medicine, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan;

关键词: MPT64;    Ultrasensitive enzyme-linked immunosorbent assay;    Viability;    Treatment monitoring;    Pulmonary tuberculosis;   

DOI  :  

来源: DOAJ

【 摘 要 】

Objectives: This study examined Mycobacterium tuberculosis (MTB)-secreted MPT64 as a surrogate of bacterial viability for the diagnosis of active pulmonary TB (PTB) and for follow-up treatment. Methods: In this proof-of-concept prospective study, 50 PTB patients in the Tokyo metropolitan region, between 2017 and 2018, were consecutively included and 30 healthy individuals were also included. Each PTB patient submitted sputum on days 0, 14 and 28 for diagnosis and follow-up, and each healthy individual submitted one sputum sample. The following were performed: smear microscopy, Xpert MTB/RIF, MGIT and solid culture, and MPT64 detection on the sputum samples. Ultrasensitive ELISA (usELISA) was used to detect MPT64. The receiver operating characteristic analyses for diagnosis and follow-up revealed the optimal cut-off value of MPT64 absorbance for detecting culture positivity at multiple intervals. Results: The sensitivity of MPT64 for diagnosing PTB was 88.0% (95% CI 75.7–95.5) and the specificity was 96.7% (95% CI 82.8–99.9). The specificity of MPT64 for predicting negative culture results on day 14 was 89.5% (95% CI 66.9–98.7). The sensitivity of MPT64 for predicting positive culture results on day 28 was 81.0% (95% CI 58.1–94.6). Conclusions: This study revealed that MPT64 is useful for diagnosing active PTB in patients and predicting treatment efficacy at follow-up.

【 授权许可】

Unknown