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Reproducibility of the T-SPOT.TB test for screening Mycobacterium tuberculosis infection in Japan
Affiliation:1. Department of Pulmonology, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan;2. Respiratory Disease Center, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama 232-0024, Japan;3. Department of Respiratory Medicine, Yokohama Minamikyousai Hospital, 1-21-1 Mutsuurahigashi, Kanazawa-ku, Yokohama, 236-0037, Japan;1. Disease Control and Prevention Center, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan;2. Department of General Internal Medicine, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan;3. Department of Pediatrics, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan;1. AMR Clinical Reference Center, Disease Control and Prevention Center, National Center for Global Health and Medicine, 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan;2. Collaborative Chairs Emerging and Reemerging Infectious Diseases, National Center for Global Health and Medicine, Graduate School of Medicine, Tohoku University, 1-1, Seriryo-tyo, Aoba-ku, Sendai, Miyagi, Japan;3. Department of Clinical Pharmacoepidemiology, Kyoto Pharmaceutical University, 5, Nakauchi-machi, Misasagi, Yamashina-ku, Kyoto-shi, Kyoto, Japan;4. Department of Pharmacy, Shizuoka Cancer Center Hospital, Shizuoka, 1007, Shimonagakubo, Nagaizumi-cho, Sundo-gun, Shizuoka, Japan;5. Division of Infectious Diseases, Shizuoka Cancer Center Hospital, 1007, Shimonagakubo, Nagaizumi-cho, Sundo-gun, Shizuoka, Japan;1. Department of Infectious Disease, Kameda Medical Center, 929 Higashi-cho, Kamogawa Chiba, 296-8602, Japan;2. Department of General Internal Medicine, Kameda Medical Center, 929 Higashi-cho, Kamogawa Chiba, 296-8602, Japan;1. Department of General Internal Medicine, Kobe City Medical Center General Hospital, Hyogo, Japan;2. Department of Pathology, Kobe City Medical Center General Hospital, Hyogo, Japan;1. Division of Hematology, Saitama Medical Center, Jichi Medical University, Japan;2. Department of General Thoracic Surgery, Saitama Medical Center, Jichi Medical University, Japan;1. Division of Blood Transfusion Medicine and Cell Therapy, Kagoshima University Hospital, 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan;2. Department of Pulmonary Medicine, Graduate School of Medical and Dental Sciences, 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan;3. Department of Diagnostic Pathology, Imamura General Hospital, 11-23 Kamoikeshinmachi, Kagoshima, 890-0064, Japan;4. Division of Antiviral Chemotherapy, Joint Research Center for Human Retrovirus Infection, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan;5. Laboratory and Vascular Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan
Abstract:ObjectivesThe interferon-gamma release assay (IGRA) is useful for diagnosing Mycobacterium tuberculosis infections, especially in countries where Bacille Calmette–Guérin vaccinations are performed. However, reproducibility of the IGRA is unclear, as recent data suggest high IGRA conversion and reversion rates in serial tests among healthcare workers. This longitudinal study aimed to evaluate reproducibility of T-SPOT.TB for screening M. tuberculosis infections in Japan.MethodsResults of T-SPOT.TB tests performed between April 2014 and March 2016 at two hospitals in Yokohama, Japan, where the incidence of tuberculosis was 18.0 per 100,000 population in 2014, were analyzed.ResultsIn total, 3890 T-SPOT.TB tests were included. Overall, positive and negative test rates were 8.4% and 87.6%, respectively. Among 373 serial tests within two years, conversion and reversion rates were only 1.1% and 12.5%, respectively. Almost all patients who were initially negative (98.9%) remained so. There was no statistically significant difference between the outcomes observed at the two hospitals.ConclusionsThe conversion rate of T-SPOT.TB in Japan is as low as that recently reported in other countries where the incidence of tuberculosis is low. These data indicate that T-SPOT.TB is a reproducible tuberculosis screening tool at local hospitals in areas with a moderate incidence of tuberculosis.
Keywords:T-SPOT.TB  Conversion rate  Reversion rate  Reproducibility  IGRA"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0035"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  interferon gamma releasing assay  TB"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0045"  },"  $$"  :[{"  #name"  :"  text"  ,"  $$"  :[{"  #name"  :"  italic"  ,"  _"  :"  Mycobacterial tuberculosis  LTBI"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0055"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  latent tuberculosis infection  HIV"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0065"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  human immunodeficiency virus  YCUMC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0075"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Yokohama City University Medical Center  YMH"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0085"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  Yokohama Minamikyousai Hospital  PBMC"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0095"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  peripheral blood mononuclear cell  ESAT-6"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0105"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  early secreted antigenic target of 6 kDa  CFP-10"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0115"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  10 kDa culture filtrate protein  IFN-γ"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0125"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  interferon gamma  QFT"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kwrd0135"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  QuantiFERON-TB Gold
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