RT Journal Article
SR Electronic
T1 Validation of a new serum granulocyte–macrophage colony-stimulating factor autoantibody testing kit
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00259-2019
DO 10.1183/23120541.00259-2019
VO 6
IS 1
A1 Koh Nakata
A1 Tatsuki Sugi
A1 Keiko Kuroda
A1 Kazutaka Yoshizawa
A1 Toshinori Takada
A1 Ryushi Tazawa
A1 Takahiro Ueda
A1 Ami Aoki
A1 Mitsuhiro Abe
A1 Koichiro Tatsumi
A1 Ryosuke Eda
A1 Shotaro Kondoh
A1 Konosuke Morimoto
A1 Takeshi Tanaka
A1 Etsuro Yamaguchi
A1 Ayumu Takahashi
A1 Miku Oda
A1 Haruyuki Ishii
A1 Shinyu Izumi
A1 Haruhito Sugiyama
A1 Atsushi Nakagawa
A1 Keisuke Tomii
A1 Masaru Suzuki
A1 Satoshi Konno
A1 Shinya Ohkouchi
A1 Taizou Hirano
A1 Tomohiro Handa
A1 Toyohiro Hirai
A1 Yoshikazu Inoue
A1 Toru Arai
A1 Katsuaki Asakawa
A1 Takuro Sakagami
A1 Takahiro Tanaka
A1 Ayako Mikami
A1 Nobutaka Kitamura
YR 2020
UL http://openres.ersjournals.com/content/6/1/00259-2019.abstract
AB 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.Using a newly developed ELISA kit, the cut-off value for serological diagnosis of autoimmune pulmonary alveolar proteinosis can be reset to 1.65 U/mL, which is externally validated against patients with conditions other than autoimmune PAP http://bit.ly/2LgFmKk