@article{oai:nagasaki-u.repo.nii.ac.jp:00000830, author = {Sakashita, Kentaro and Takeuchi, Rikiya and Takeda, Keita and Takamori, Mikio and Ito, Kensuke and Igarashi, Yuriko and Hayashi, Eiji and Iguchi, Mari and Ono, Masahiro and Kashiyama, Tetsuya and Tachibana, Masatoshi and Miyakoshi, Jun and Yano, Koichi and Sato, Yu and Yamamoto, Miyake and Murata, Kengo and Wada, Akihiko and Chikamatsu, Kinuyo and Aono, Akio and Takaki, Akiko and Nagai, Hideaki and Yamane, Akira and Kawashima, Masahiro and Komatsu, Mariko and Nakaishi, Kazunari and Watabe, Satoshi and Mitarai, Satoshi}, journal = {International Journal of Infectious Diseases}, month = {Apr}, note = {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., International Journal of Infectious Diseases, 96, pp.244-253; 2020}, pages = {244--253}, title = {Ultrasensitive enzyme-linked immunosorbent assay for the detection of MPT64 secretory antigen to evaluate Mycobacterium tuberculosis viability in sputum}, volume = {96}, year = {2020} }