title: Evaluation of phosphatidylserine-dependent antiprothrombin antibody testing for the diagnosis of antiphospholipid syndrome: results of an international multicentre study.
abstract: Objective A task force of scientists at the International Congress on Antiphospholipid Antibodies recognized that phosphatidylserine-dependent antiprothrombin antibodies (aPS/PT) might contribute to a better identification of antiphospholipid syndrome (APS). Accordingly, initial and replication retrospective, cross-sectional multicentre studies were conducted to ascertain the value of aPS/PT for APS diagnosis. Methods In the initial study (eight centres, seven countries), clinical/laboratory data were retrospectively collected. Serum/plasma samples were tested for IgG aPS/PT at Inova Diagnostics (Inova) using two ELISA kits. A replication study (five centres, five countries) was carried out afterwards. Results In the initial study ( n = 247), a moderate agreement between the IgG aPS/PT Inova and MBL ELISA kits was observed ( k = 0.598). IgG aPS/PT were more prevalent in APS patients (51%) than in those without (9%), OR 10.8, 95% CI (4.0-29.3), p < 0.0001. Sensitivity, specificity, positive (LR+) and negative (LR-) likelihood ratio of IgG aPS/PT for APS diagnosis were 51%, 91%, 5.9 and 0.5, respectively. In the replication study ( n = 214), a moderate/substantial agreement between the IgG aPS/PT results obtained with both ELISA kits was observed ( k = 0.630). IgG aPS/PT were more prevalent in APS patients (47%) than in those without (12%), OR 6.4, 95% CI (2.6-16), p < 0.0001. Sensitivity, specificity, LR + and LR- for APS diagnosis were 47%, 88%, 3.9 and 0.6, respectively. Conclusions IgG aPS/PT detection is an easily performed laboratory parameter that might contribute to a better and more complete identification of patients with APS.
authors: 1 Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors: O
authors: O
authors: Amengual
authors: 2 Instituto de Medicina Traslacional, Trasplante y Bioingeniería (IMeTTyB), Universidad Favaloro-CONICET, Departamento de Fisiologia, Hemostasia y Trombosis, Buenos Aires, Argentina.
authors: R
authors: R
authors: Forastiero
authors: 3 Department of Obstetrics and Gynecology, Nagoya City University, Graduated School of Medical Sciences, Nagoya, Japan.
authors: M
authors: M
authors: Sugiura-Ogasawara
authors: 1 Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors: K
authors: K
authors: Otomo
authors: 1 Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors: K
authors: K
authors: Oku
authors: 4 Department of Medicine IV, Fernando Fonseca Hospital, Amadora and CEDOC/NOVA Medical School, Lisbon, Portugal.
authors: C
authors: C
authors: Favas
authors: 4 Department of Medicine IV, Fernando Fonseca Hospital, Amadora and CEDOC/NOVA Medical School, Lisbon, Portugal.
authors: J
authors: J
authors: Delgado Alves
authors: 5 Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
authors: P
authors: P
authors: Žigon
authors: 5 Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
authors: A
authors: A
authors: Ambrožič
authors: 5 Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
authors: M
authors: M
authors: Tomšič
authors: 6 Autoimmune Diseases Research Unit, Department of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, University of The Basque Country, Spain.
authors: I
authors: I
authors: Ruiz-Arruza
authors: 6 Autoimmune Diseases Research Unit, Department of Internal Medicine, Biocruces Health Research Institute, Hospital Universitario Cruces, University of The Basque Country, Spain.
authors: G
authors: G
authors: Ruiz-Irastorza
authors: 7 Academic Department of Vascular Surgery, Cardiovascular Division, King's College London, UK.
authors: M L
authors: ML
authors: Bertolaccini
authors: 8 Inova Diagnostics Inc., San Diego, CA, USA.
authors: G L
authors: GL
authors: Norman
authors: 8 Inova Diagnostics Inc., San Diego, CA, USA.
authors: Z
authors: Z
authors: Shums
authors: 9 Medical and Biological Laboratories, Co. Ltd, Nagano, Japan.
authors: J
authors: J
authors: Arai
authors: 10 Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.
authors: A
authors: A
authors: Murashima
authors: 11 Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake City, UT, USA.
authors: A E
authors: AE
authors: Tebo
authors: 12 Department of Clinical Sciences and Community Health, Istituto Auxologico Italiano, University of Milan, Milan, Italy.
authors: M
authors: M
authors: Gerosa
authors: 12 Department of Clinical Sciences and Community Health, Istituto Auxologico Italiano, University of Milan, Milan, Italy.
authors: P L
authors: PL
authors: Meroni
authors: 13 Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Barcelona, Catalonia, Spain.
authors: I
authors: I
authors: Rodriguez-Pintó
authors: 13 Department of Autoimmune Diseases, Hospital Clínic, University of Barcelona, Barcelona, Catalonia, Spain.
authors: R
authors: R
authors: Cervera
authors: 14 Department of Medicine Jagiellonian University, Cracow, Poland.
authors: J
authors: J
authors: Swadzba
authors: 14 Department of Medicine Jagiellonian University, Cracow, Poland.
authors: J
authors: J
authors: Musial
authors: 1 Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors: T
authors: T
authors: Atsumi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017152:Antibodies, Antiphospholipid / Q000097:blood*; D016736:Antiphospholipid Syndrome / Q000097:blood / Q000175:diagnosis*; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D007391:International Cooperation; D008180:Lupus Erythematosus, Systemic / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010718:Phosphatidylserines / Q000276:immunology*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000097:blood / Q000175:diagnosis*; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013927:Thrombosis / Q000175:diagnosis*; D055815:Young Adult
chemical_list: D017152:Antibodies, Antiphospholipid; D010718:Phosphatidylserines
keywords: Antiphospholipid antibodies; lupus anticoagulant; systemic lupus erythematosus; thrombosis