Evaluation of phosphatidylserine-dependent antiprothrombin antibody testing for the diagnosis of antiphospholipid syndrome: results of an international multicentre study

被引:42
作者
Amengual, O. [1 ]
Forastiero, R. [2 ]
Sugiura-Ogasawara, M. [3 ]
Otomo, K. [1 ]
Oku, K. [1 ]
Favas, C. [4 ,5 ]
Alves, J. Delgado [4 ,5 ]
Zigon, P. [6 ]
Ambrozic, A. [6 ]
Tomsic, M. [6 ]
Ruiz-Arruza, I. [7 ]
Ruiz-Irastorza, G. [7 ]
Bertolaccini, M. L. [8 ]
Norman, G. L. [9 ]
Shums, Z. [9 ]
Arai, J. [10 ]
Murashima, A. [11 ]
Tebo, A. E. [12 ,13 ]
Gerosa, M. [14 ]
Meroni, P. L. [14 ]
Rodriguez-Pinto, I. [15 ]
Cervera, R. [15 ]
Swadzba, J. [16 ]
Musial, J. [16 ]
Atsumi, T. [1 ]
机构
[1] Hokkaido Univ, Grad Sch Med, Div Rheumatol Endocrinol & Nephrol, Sapporo, Hokkaido, Japan
[2] Univ Favaloro CONICET, Inst Med Traslac Trasplante & Bioingn IMeTTyB, Dept Fisiol Hemostasia & Trombosis, Buenos Aires, DF, Argentina
[3] Nagoya City Univ, Grad Sch Med Sci, Dept Obstet & Gynecol, Nagoya, Aichi, Japan
[4] Fernando Fonseca Hosp, Dept Med 4, Amadora, Portugal
[5] CEDOC NOVA Med Sch, Lisbon, Portugal
[6] Univ Med Ctr Ljubljana, Dept Rheumatol, Ljubljana, Slovenia
[7] Univ Basque Country, Hosp Univ Cruces, Biocruces Hlth Res Inst, Dept Internal Med,Autoimmune Dis Res Unit, Vizcaya, Spain
[8] Kings Coll London, Div Cardiovasc, Acad Dept Vasc Surg, London, England
[9] Inova Diagnost Inc, San Diego, CA USA
[10] Med & Biol Labs Co Ltd, Nagano, Japan
[11] Natl Ctr Child Hlth & Dev, Ctr Maternal Fetal Neonatal & Reprod Med, Tokyo, Japan
[12] Univ Utah, Dept Pathol, Salt Lake City, UT USA
[13] ARUP Labs, Salt Lake City, UT USA
[14] Univ Milan, Ist Auxol Italiano, Dept Clin Sci & Community Hlth, Milan, Italy
[15] Univ Barcelona, Hosp Clin, Dept Autoimmune Dis, Barcelona, Catalonia, Spain
[16] Jagiellonian Univ, Dept Med, Krakow, Poland
关键词
Antiphospholipid antibodies; thrombosis; lupus anticoagulant; systemic lupus erythematosus; SYSTEMIC-LUPUS-ERYTHEMATOSUS; PROTHROMBIN ANTIBODIES; CLINICAL-SIGNIFICANCE; ANTIPHOSPHATIDYLSERINE/PROTHROMBIN ANTIBODIES; RISK-FACTOR; THROMBOSIS; AUTOANTIBODIES; COMPLEX; MANIFESTATIONS; ANTICOAGULANT;
D O I
10.1177/0961203316660203
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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页码:266 / 276
页数:11
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