ERJ Open Research (Jan 2020)
Validation of a new serum granulocyte–macrophage colony-stimulating factor autoantibody testing kit
- Koh Nakata,
- Tatsuki Sugi,
- Keiko Kuroda,
- Kazutaka Yoshizawa,
- Toshinori Takada,
- Ryushi Tazawa,
- Takahiro Ueda,
- Ami Aoki,
- Mitsuhiro Abe,
- Koichiro Tatsumi,
- Ryosuke Eda,
- Shotaro Kondoh,
- Konosuke Morimoto,
- Takeshi Tanaka,
- Etsuro Yamaguchi,
- Ayumu Takahashi,
- Miku Oda,
- Haruyuki Ishii,
- Shinyu Izumi,
- Haruhito Sugiyama,
- Atsushi Nakagawa,
- Keisuke Tomii,
- Masaru Suzuki,
- Satoshi Konno,
- Shinya Ohkouchi,
- Taizou Hirano,
- Tomohiro Handa,
- Toyohiro Hirai,
- Yoshikazu Inoue,
- Toru Arai,
- Katsuaki Asakawa,
- Takuro Sakagami,
- Takahiro Tanaka,
- Ayako Mikami,
- Nobutaka Kitamura
Affiliations
- Koh Nakata
- Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan
- Tatsuki Sugi
- IVD Development Unit, Ina Laboratory, Medical and Biological Laboratories, Ltd, Nagoya, Japan
- Keiko Kuroda
- IVD Development Unit, Ina Laboratory, Medical and Biological Laboratories, Ltd, Nagoya, Japan
- Kazutaka Yoshizawa
- Dept of Respiratory and Infectious Disease, Niigata University Medical and Dental Hospital, Niigata, Japan
- Toshinori Takada
- Uonuma Institute of Community Medicine, Niigata University Medical and Dental Hospital, Minami-Uonuma, Japan
- Ryushi Tazawa
- Health Administration Center, Tokyo Medical and Dental University, Tokyo, Japan
- Takahiro Ueda
- Office of New Drug IV, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
- Ami Aoki
- Dept of Respiratory and Infectious Disease, Niigata University Medical and Dental Hospital, Niigata, Japan
- Mitsuhiro Abe
- Dept of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan
- Koichiro Tatsumi
- Dept of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan
- Ryosuke Eda
- Kurashiki Municipal Hospital, Kurashiki, Japan
- Shotaro Kondoh
- Kurashiki Municipal Hospital, Kurashiki, Japan
- Konosuke Morimoto
- Dept of Clinical Medicine, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan
- Takeshi Tanaka
- Dept of Clinical Medicine, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan
- Etsuro Yamaguchi
- Division of Respiratory Medicine and Allergology, Dept of Medicine, Aichi Medical University School of Medicine, Aichi, Japan
- Ayumu Takahashi
- Division of Respiratory Medicine and Allergology, Dept of Medicine, Aichi Medical University School of Medicine, Aichi, Japan
- Miku Oda
- Dept of Respiratory Medicine, Kyorin University School of Medicine, Tokyo, Japan
- Haruyuki Ishii
- Dept of Respiratory Medicine, Kyorin University School of Medicine, Tokyo, Japan
- Shinyu Izumi
- Dept of Respiratory Medicine, Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan
- Haruhito Sugiyama
- Dept of Respiratory Medicine, Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan
- Atsushi Nakagawa
- Kobe City Medical Center General Hospital, Kobe, Japan
- Keisuke Tomii
- Kobe City Medical Center General Hospital, Kobe, Japan
- Masaru Suzuki
- Dept of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan
- Satoshi Konno
- Dept of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan
- Shinya Ohkouchi
- Dept of Respiratory Medicine and Dept of Occupational Health, Tohoku University Graduate School of Medicine, Sendai, Japan
- Taizou Hirano
- Dept of Respiratory Medicine and Dept of Occupational Health, Tohoku University Graduate School of Medicine, Sendai, Japan
- Tomohiro Handa
- Dept of Advanced Medicine for Respiratory Failure and Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
- Toyohiro Hirai
- Dept of Advanced Medicine for Respiratory Failure and Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
- Yoshikazu Inoue
- National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan
- Toru Arai
- National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan
- Katsuaki Asakawa
- Dept of Respiratory and Infectious Disease, Niigata University Medical and Dental Hospital, Niigata, Japan
- Takuro Sakagami
- Dept of Respiratory Medicine, Kumamoto University Hospital, Kumamoto, Japan
- Takahiro Tanaka
- Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan
- Ayako Mikami
- Dept of Respiratory Medicine, Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan
- Nobutaka Kitamura
- Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan
- DOI
- https://doi.org/10.1183/23120541.00259-2019
- Journal volume & issue
-
Vol. 6,
no. 1
Abstract
Very recently, a modest but significant efficacy of granulocyte–macrophage colony-stimulating factor (GM-CSF) inhalation therapy for the treatment of mild to moderate autoimmune pulmonary alveolar proteinosis (aPAP) has been reported. As the ability to measure the level of GM-CSF autoantibody (GMAb) in the serum is required to decide the indication for this therapy, we developed a high-performance GMAb testing kit for clinical use. As the kit succeeded in reducing nonspecific IgG binding to the ELISA plate, the predictive performance shown in the training study to discriminate aPAP patients from healthy subjects was perfect, providing a cut-off value of 1.65 U·mL−1 in 78 patients with aPAP and 90 healthy subjects in an operator-blinded manner using logistic regression analysis. As in the validation study, serum samples from another 213 patients with aPAP were also blinded and evaluated in an operator-blinded manner against external 207 samples from patients with other types of PAP and patients exhibiting various ground-glass opacities on chest high-resolution computed tomography that require discrimination from PAP. The logistic regression analysis of these validation data sets revealed values of 97.6% and 100% for specificity and sensitivity, respectively. Thus, this new GMAb testing kit is reliable for the diagnosis of aPAP and differential diagnosis of other lung diseases.
