Validation of a commercially available kit to detect anti-phosphatidylserine/prothrombin antibodies in a cohort of systemic lupus erythematosus patients

Sciascia, Savino; Sanna, Giovanni; Murru, Veronica; Khamashta, Munther A.; Bertolaccini, Maria Laura

doi:10.1016/j.thromres.2013.12.001

Cited by 25 publications

(23 citation statements)

References 17 publications

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“…In such cases, a further diagnostic tool for APS with reliable performances might be crucial to guide the diagnostic process and to avoid under/over treatment (31). Finally, testing for aPS/PT by a commercial kit was proven to be a reproducible and accurate test for the detection of aPS/PT, bringing the added advantage of shorter running times when compared to in-house assays (32).…”

Section: Discussionmentioning

confidence: 99%

Reliability of Lupus Anticoagulant and Anti-phosphatidylserine/prothrombin Autoantibodies in Antiphospholipid Syndrome: A Multicenter Study

et al. 2019

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Background: Is it well-known that one of the major drawbacks of Lupus Anticoagulant (LA) test is their sensitivity to anticoagulant therapy, due to the coagulation based principle. In this study we aimed to assess the reproducibility of LA testing and to evaluate the performance of solid assay phosphatidylserine/prothrombin (aPS/PT) antibodies.Methods: We included 60 patients that fulfilled the following inclusion criteria: (I) diagnosis of thrombotic antiphospholipid syndrome (APS); (II) patients with thrombosis and (a) inconstant previous LA positivity and/or (b) positivity for antiphospholipid antibodies (aPL) at low-medium titers [defined as levels of anti-β2Glycoprotein-I or anticardiolipin (IgG/IgM) 10–30 GPL/MPL] with no previous evidence of LA positivity. aPL testing was performed blindly in 4 centers undertaking periodic external quality assessment.Results: The 60 patients enrolled were distributed as follows: 43 (71.7%) with thrombotic APS, 7 (11.7%) with thrombosis and inconstant LA positivity and 10 (16.7%) with low-medium aPL titers. Categorical agreement for LA among the centers ranged from 0.41 to 0.60 (Cohen's kappa coefficient; moderate agreement). The correlation determined at the 4 sites for aPS/PT was strong, both quantitatively (Spearman rho 0.84) and when dichotomized (Cohen's kappa coefficients = 0.81 to 1.0). Discordant (as defined by lack of agreement in ≥3 laboratories) or inconclusive LA results were observed in 27/60 (45%) cases; when limiting the analysis to those receiving vitamin K antagonist (VKA), the level of discordant LA results was as high as 75%(15/20). Conversely, aPS/PT testing showed an overall agreement of 83% (up to 90% in patients receiving VKA), providing an overall increase in test reproducibility of +28% when compared to LA, becoming even more evident (+65%) when analyzing patients on VKA. In patients treated with VKA, we observed a good correlation for aPS/PT IgG testing (Cohen's kappa coefficients = 0.81–1; Spearman rho 0.86).Conclusion: Despite the progress in the standardization of aPL testing, we observed up to 45% of overall discrepant results for LA, even higher in patients on VKA. The introduction of aPS/PT testing might represent a further diagnostic tool, especially when LA testing is not available or the results are uncertain.

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Section: Discussionmentioning

confidence: 99%

Reliability of Lupus Anticoagulant and Anti-phosphatidylserine/prothrombin Autoantibodies in Antiphospholipid Syndrome: A Multicenter Study

et al. 2019

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“…Finally, we analyzed the SN-APS sera for the presence of antibodies against two major cofactor proteins for aPL, prothrombin and annexin V. Our results revealed that 3 out of 24 sera from SN-APS patients (12.5%) displayed antibodies to prothrombin and 1 (4.2%) to annexin V. The datum of antiprothrombin might be underestimated, since we tested anti-prothrombin antibodies in the absence of phosphatidylserine. Indeed, anti-phosphatidylserine/prothrombin antibodies, which have been recently standardized and validated [34], seemed to represent a stronger risk factor for thrombosis than antiprothrombin [35]. However, interestingly, in SN-APS group, anti-prothrombin antibodies were detected in 3 patients, which were negative for aCL by TLC immunostaining.…”

Section: Discussionmentioning

confidence: 99%

The Mosaic of “Seronegative” Antiphospholipid Syndrome

Conti

Capozzi

Truglia

et al. 2014

Journal of Immunology Research

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In the clinical practice it is possible to find patients with clinical signs suggestive of antiphospholipid syndrome (APS), who are persistently negative for the laboratory criteria of APS, that is, anti-cardiolipin antibodies (aCL), anti-β 2-GPI antibodies and lupus anticoagulant. Therefore, it was proposed for these cases the term of seronegative APS (SN-APS). In order to detect autoantibodies with different methodological approaches, sera from 24 patients with SN-APS were analysed for anti-phospholipid antibodies using TLC immunostaining, for anti-vimentin/cardiolipin antibodies by enzyme-linked immunosorbent assay (ELISA), and for anti-annexin V and anti-prothrombin antibodies by ELISA and dot blot. Control groups of our study were 25 patients with APS, 18 with systemic lupus erythematosus (SLE), and 32 healthy controls. Results revealed that 13/24 (54.2%) SN-APS sera were positive for aCL (9 of whom were also positive for lysobisphosphatidic acid) by TLC immunostaining, 11/24 (45.8%) for anti-vimentin/cardiolipin antibodies, 3/24 (12.5%) for anti-prothrombin antibodies, and 1/24 (4.2%) for anti-annexin V antibodies. These findings suggest that in sera from patients with SN-APS, antibodies may be detected using “new” antigenic targets (mainly vimentin/cardiolipin) or methodological approaches different from traditional techniques (mainly TLC immunostaining). Thus, SN-APS represents a mosaic, in which antibodies against different antigenic targets may be detected.

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“…Some interest has focused on the mitochondrial membrane antigen M5 which is associated with thrombocytopenia and fetal loss, and coexists with LA, aCL, anti-β2GP1, and biologically false-positive VDRL [142,143]. With the availability of a commercial anti-PS/PT assay [144], a number of reports have focused on its value [145], particularly its use in closing the seronegative gap in APS [141,146]. Although the presence of anti-PS/PT antibodies appear to be independent of the LA, they may be a potential substitute for the troubled LA assay [146,147].…”

Section: Non-criteria Autoantibodies: Phosphatidylserine/prothrombin mentioning

confidence: 99%

Challenges and Advances in SLE Autoantibody Detection and Interpretation

Choi

Fritzler

2019

Curr Treat Options in Rheum

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Purpose of review This review is an overview of key autoantibodies used in the diagnosis and management of SLE. Questions addressed are the advantages to but limitations of ANA testing and what are the key considerations in ordering ANA tests and then interpreting the ANA results. Recent findings There is a progressive move towards • Solid-phase multi-analyte arrays with algorithmic analysis (SPMAAA) • Closing the seronegative gap in SLE • Harmonization of ANA testing Summary As an approach to limiting morbidity and rising health care costs associated with SLE, the future of ANA testing should focus on making an accurate and actionable diagnosis of very early SLE. To achieve this goal, harmonization of autoantibody testing will be important. Autoantibodies in SLE Choi and Fritzler

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Validation of a commercially available kit to detect anti-phosphatidylserine/prothrombin antibodies in a cohort of systemic lupus erythematosus patients

Cited by 25 publications

References 17 publications

Reliability of Lupus Anticoagulant and Anti-phosphatidylserine/prothrombin Autoantibodies in Antiphospholipid Syndrome: A Multicenter Study

Reliability of Lupus Anticoagulant and Anti-phosphatidylserine/prothrombin Autoantibodies in Antiphospholipid Syndrome: A Multicenter Study

The Mosaic of “Seronegative” Antiphospholipid Syndrome

Challenges and Advances in SLE Autoantibody Detection and Interpretation

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