title: Rapid Immunochromatographic Detection of Serum Anti-α-Galactosidase A Antibodies in Fabry Patients after Enzyme Replacement Therapy.
abstract: We developed an immunochromatography-based assay for detecting antibodies against recombinant α-galactosidase A proteins in serum. The evaluation of 29 serum samples from Fabry patients, who had received enzyme replacement therapy with agalsidase alpha and/or agalsidase beta, was performed by means of this assay method, and the results clearly revealed that the patients exhibited the same level of antibodies against both agalsidase alpha and agalsidase beta, regardless of the species of recombinant α-galactosidase A used for enzyme replacement therapy. A conventional enzyme-linked immunosorbent assay supported the results. Considering these, enzyme replacement therapy with agalsidase alpha or agalsidase beta would generate antibodies against the common epitopes in both agalsidase alpha and agalsidase beta. Most of the patients who showed immunopositive reaction exhibited classic Fabry phenotype and harbored gene mutations affecting biosynthesis of α-galactosidase A. As immunochromatography is a handy and simple assay system which can be available at bedside, this assay method would be extremely useful for quick evaluation or first screening of serum antibodies against agalsidase alpha or agalsidase beta in Fabry disease with enzyme replacement therapy.
authors.affiliation: Department of Molecular Medical Research, Tokyo Metropolitan Institute of Medical Science, 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo156-8506, Japan; Synthera Technologies Co., Ltd., 4-5-1 Honkomagome, Bunkyo-ku, Tokyo 113-0021, Japan.
authors.forename: Sachie
authors.initials: S
authors.lastname: Nakano
authors.affiliation: Department of Functional Bioanalysis, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose, Tokyo 204-8588, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Tsukimura
authors.affiliation: Department of Functional Bioanalysis, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose, Tokyo 204-8588, Japan.
authors.forename: Tadayasu
authors.initials: T
authors.lastname: Togawa
authors.affiliation: Department of Gene Therapy, Institute of DNA Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.
authors.forename: Toya
authors.initials: T
authors.lastname: Ohashi
authors.affiliation: Department of Pediatrics, The Jikei University School of Medicine, 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, 105-8461, Japan.
authors.forename: Masahisa
authors.initials: M
authors.lastname: Kobayashi
authors.affiliation: ADTEC Co., Ltd. 1693-6 Yokkaichi, Usa-City, Oita, 879-0471, Japan.
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Takayama
authors.affiliation: ADTEC Co., Ltd. 1693-6 Yokkaichi, Usa-City, Oita, 879-0471, Japan.
authors.forename: Yukuharu
authors.initials: Y
authors.lastname: Kobayashi
authors.affiliation: Nihonkai General Hospital, 30 Akiho, Sakata, Yamagata 998-8501, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Abiko
authors.affiliation: Koujin-kai Kimachi Hospital, 1-7-13 Kimachi-dori, Aoba-ku, Sendai, Miyagi 980-0801, Japan.
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Satou
authors.affiliation: Mutsu General Hospital, 1-2-8 Ogawa-Cho, Mutsu, Aomori 035-8601, Japan.
authors.forename: Tohru
authors.initials: T
authors.lastname: Nakahata
authors.affiliation: Division of Nephrology, The University of Alabama School of Medicine, 619S 19th Street, Birmingham, AL 35249, United States of America.
authors.forename: David G
authors.initials: DG
authors.lastname: Warnock
authors.affiliation: Department of Clinical Genetics, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose, Tokyo 204-8588, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sakuraba
authors.affiliation: Department of Molecular Medical Research, Tokyo Metropolitan Institute of Medical Science, 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo156-8506, Japan.
authors.forename: Futoshi
authors.initials: F
authors.lastname: Shibasaki
mesh_terms: D000293:Adolescent; D000328:Adult; D000906:Antibodies / Q000097:blood*; D002648:Child; D002846:Chromatography, Affinity; D056947:Enzyme Replacement Therapy; D004797:Enzyme-Linked Immunosorbent Assay; D000795:Fabry Disease / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D005260:Female; D005838:Genotype; D006801:Humans; D007527:Isoenzymes / Q000276:immunology / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010641:Phenotype; D011994:Recombinant Proteins; D055815:Young Adult; D000519:alpha-Galactosidase / Q000276:immunology / Q000627:therapeutic use*
chemical_list: D000906:Antibodies; D007527:Isoenzymes; D011994:Recombinant Proteins; C000627036:agalsidase alfa; D000519:alpha-Galactosidase; C459420:agalsidase beta