title: Significance of fully automated tests for the diagnosis of antiphospholipid syndrome.
abstract: Antiphospholipid antibodies (aPLs) can vary both immunologically and functionally, thus it is important to effectively and correctly identify their presence when diagnosing antiphospholipid syndrome. Furthermore, since many immunological/functional tests are necessary to measure aPLs, complete examinations are often not performed in many cases due to significant burden on the testing departments. To address this issue, we measured aPLs defined according to the classification criteria (anticardiolipin antibody: aCL) IgG/IgM and anti-β2glycoprotein I antibody (aβ2GPI) (IgG/IgM) as well as non-criteria antibodies (aCL IgA, aβ2GPI IgA and aβ2GPI domain I), in a cohort of 211 patients (61 APS, 140 disease controls and 10 healthy individuals). APLs were measured using a fully automated chemiluminescent immunoassay instrument (BIO-FLASH®/ACL AcuStar®) and with conventional ELISA tests. We demonstrated that both sensitivity and accuracy of diagnosis of aCL IgG and aβ2GPI IgG were high, in agreement with the past reports. When multiple aPLs were examined, the accuracy of diagnosis increased. The proportion of APS patients that were positive for 2 or more types of aPLs (47/61, 77%) was higher than that of patients with systemic lupus erythematosus (SLE)(3/37, 9%), those with non-SLE connective tissues diseases (1/53,2%), those with other diseases or healthy volunteers. Based on these findings, it was concluded that the fully automated chemiluminescent immunoassay instrument, which allows the simultaneous evaluation of many types of aPLs, offers clear advantages for a more complete, more rapid and less labor-intensive alternative to running multiple ELISA and could help in better diagnosis for suspected APS patients.
authors.affiliation: Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan. Electronic address: kenoku@med.hokudai.ac.jp.
authors.forename: Kenji
authors.initials: K
authors.lastname: Oku
authors.affiliation: Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Olga
authors.initials: O
authors.lastname: Amengual
authors.affiliation: Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Kato
authors.affiliation: Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Bohgaki
authors.affiliation: Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Horita
authors.affiliation: Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Yasuda
authors.affiliation: Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Naoya
authors.initials: N
authors.lastname: Sakamoto
authors.affiliation: Department of Internal Medicine, Health Science University of Hokkaido, To-betsu Cho, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Ieko
authors.affiliation: Inova Diagnostics Inc., San Diego, CA, USA.
authors.forename: Gary L
authors.initials: GL
authors.lastname: Norman
authors.affiliation: Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Atsumi
mesh_terms: D017153:Antibodies, Anticardiolipin / Q000032:analysis / Q000378:metabolism*; D016736:Antiphospholipid Syndrome / Q000175:diagnosis* / Q000276:immunology; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male
chemical_list: D017153:Antibodies, Anticardiolipin
keywords: Anti-β(2)GPI antibody; Anticardiolipin antibody; Antiphospholipid syndrome; Automated chemiluminescent immunoassay