Two Novel Technologies for the Detection of Anti-cardiolipin and Anti β2–Glycoprotein Antibodies in the Real Life: Chemiluminescent in Comparison to the Addressable Laser Bead Immunoassays

Grossi, Valentina; Infantino, María; Benucci, Maurizio; Gobbi, Francesca Li; Bandinelli, Francesca; Damiani, Arianna; Bodio, Caterina; Borghi, Maria Orietta; Mähler, Michael; Aure, Mary Ann; Bentow, Chelsea; Manfredi, Mariangela

doi:10.1080/08820139.2019.1647233

Cited by 8 publications

(5 citation statements)

References 23 publications

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“…Automated platforms using different techniques, such as CLIA and MFI, have some advantages over ELISA, are commercially available as alternatives for ELISA, and perform well 24 . However, they also show inter‐assay variability and limited numerical agreement with ELISA 7,11,12,25,26 …”

Section: Discussionmentioning

confidence: 99%

“…24 However, they also show inter-assay variability and limited numerical agreement with ELISA. 7,11,12,25,26 Current classification criteria for APS, as well as classification criteria for systemic lupus erythematosus include aPL. 1,27 The main purpose of the consensus APS classification criteria is to provide uniform guidelines and patient selection criteria for scientific research, and are not meant for diagnosis, although these same laboratory criteria are fulfilled for the majority of the patients at the time of diagnosis.…”

Section: Discussionmentioning

confidence: 99%

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Semiquantitative interpretation of anticardiolipin and antiβ2glycoprotein I antibodies measured with various analytical platforms: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

Vandevelde

Chayouâ

Laat

et al. 2022

Journal of Thrombosis and Haemostasis

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Background: Antiβ2glycoprotein I (aβ2GPI) and anticardiolipin (aCL) IgG/IgM show differences in positive/negative agreement and titers between solid phase platforms. Method-specific semiquantitative categorization of titers could improve and harmonize the interpretation across platforms. Aim: To evaluate the traditional 40/80-unit thresholds used for aCL and aβ2GPI for categorization into moderate/high positivity with different analytical systems, and to compare with alternative thresholds. Material and methods: aCL and aβ2GPI thresholds were calculated for two automated systems (chemiluminescent immunoassay [CLIA] and multiplex flow immunoassay [MFI]) by receiver operating characteristic curve analysis on 1108 patient samples, including patients with and without antiphospholipid syndrome (APS), and confirmed on a second population (n = 279). Alternatively, regression analysis on diluted standard material was applied to identify thresholds. Thresholds were compared to 40/80 threshold measured by an enzyme-linked immunosorbent assay (ELISA). Additionally, likelihood ratios (LR) were calculated. Results: Threshold levels of 40/80 units show poor agreement between ELISA and automated platforms for classification into low/moderate/high positivity, especially for aCL/aβ2GPI IgG. Agreement for semiquantitative interpretation of antiphospholipid antibodies (aPL) IgG between ELISA and CLIA/MFI improves with alternative thresholds. LR for aPL IgG increase for thrombotic and obstetric APS based on 40/80 thresholds for ELISA and adapted thresholds for the other systems, but not for IgM.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Semiquantitative interpretation of anticardiolipin and antiβ2glycoprotein I antibodies measured with various analytical platforms: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

Vandevelde

Chayouâ

Laat

et al. 2022

Journal of Thrombosis and Haemostasis

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“…Large heterogeneity in assay techniques, reagents, and calibrators leads to high interassay variability. Variability is observed both in qualitative (positive/negative) and quantitative (antibody titer) interpretation of aCL and aβ2GPI results, especially between ELISA and automated platforms using newer techniques such as chemiluminescence [117,[122][123][124][125]. While agreement between commercially available immunoassays is poor for individual aCL and aβ2GPI IgG or IgM detection, assays showed comparable clinical accuracy when all criteria solid-phase aPL were determined [122].…”

Section: Anticardiolipin and Anti-β2-glycoprotein I Igg/igm Antibodie...mentioning

confidence: 99%

Laboratory Diagnosis of Antiphospholipid Syndrome: Insights and Hindrances

Vandevelde

Devreese

2022

JCM

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Diagnosis of antiphospholipid syndrome (APS) requires the presence of a clinical criterion (thrombosis and/or pregnancy morbidity), combined with persistently circulating antiphospholipid antibodies (aPL). Currently, laboratory criteria aPL consist of lupus anticoagulant (LAC), anticardiolipin antibodies (aCL) IgG/IgM, and anti-β2 glycoprotein I antibodies (aβ2GPI) IgG/IgM. Diagnosis and risk stratification of APS are complex and efforts to standardize and optimize laboratory tests have been ongoing since the initial description of the syndrome. LAC detection is based on functional coagulation assays, while aCL and aβ2GPI are measured with immunological solid-phase assays. LAC assays are especially prone to interference by anticoagulation therapy, but strategies to circumvent this interference are promising. Alternative techniques such as thrombin generation for LAC detection and to estimate LAC pathogenicity have been suggested, but are not applicable yet in routine setting. For aCL and aβ2GPI, a lot of different assays and detection techniques such as enzyme-linked immunosorbent and chemiluminescent assays are available. Furthermore, a lack of universal calibrators or standards results in high variability between the different solid-phase assays. Other non-criteria aPL such as anti-domain I β2 glycoprotein I and antiphosphatidylserine/prothrombin antibodies have been suggested for risk stratification purposes in APS, while their added value to diagnostic criteria seems limited. In this review, we will describe laboratory assays for diagnostic and risk evaluation in APS, integrating applicable guidelines and classification criteria. Current insights and hindrances are addressed with respect to both laboratory and clinical implications.

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“…The cut-off for positivity of aCL and anti-β2GPI recommended by the manufacturer is >20 U/mL. Grossi et al [86] compared the results of 134 patients on MFFIA and CLIA and demonstrated a very good compliance between both methods. Compliance for aCL IgG was 88.1%, and for anti-β2GPI IgG was 97.8%.…”

Section: Multiplex Flow Fluorescence Immunoassaymentioning

confidence: 99%

Current Promising Biomarkers and Methods in the Diagnostics of Antiphospholipid Syndrome: A Review

et al. 2021

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Antiphospholipid syndrome (APS) is a hypercoagulation condition associated with the incidence of heterogenic antiphospholipid antibodies (aPLs), which non-specifically affect hemostasis processes. APS is clinically manifested by recurrent arterial and venous thromboses and reproduction losses. The aPL antibodies, which may induce clinical manifestations of APS, include criteria antibodies anti-cardiolipin, anti-β2-glycoprotein-I, and lupus anticoagulant, but also non-criteria antibodies, for example anti-β2-glycoprotein-I domain I, anti-phosphatidylserine/prothrombin, anti-annexin V, and many others. APS occurs mostly in patients of younger and middle age, most frequently in females. Laboratory diagnostics of APS are quite difficult, as they include a wide spectrum of examining methods, which are based on various principles of detection and are performed using various laboratory techniques. The objective of the review is to describe the current state of potentially examined biomarkers and methods in APS diagnostics. The aforementioned biomarkers are lupus anticoagulant, anti-β2-glycoprotein-I, anti-cardiolipin, anti-β2-glycoprotein-I domain I, anti-phosphatidylserine/prothrombin, anti-β2-glycoprotein-I IgA, anti-cardiolipin IgA, anti-annexin V and II, anti-prothrombin, anti-cardiolipin/vimentin, anti-protein S/protein C, and antibodies against phospholipid antigens for whose diagnostics we may use some of the methods established for a long time and some of the modern methods—the coagulation method for the determination of lupus anticoagulant (LA), enzyme-linked imunosorbent assay (ELISA), chemiluminescence analysis (CLIA), multiplex fluorescence flow immunoassay (MFFIA), fluorescence enzyme immunoassay (EliA), line immunoassay (LIA), multiline dot assay (MLDA), and thin-layer chromatography (TLC). Conclusion: Antibodies against phosphatidylethanolamine, phosphatidic acid, phosphatidylserine, phosphatidylinositol, cardiolipin/vimentin complex, and annexin V are currently the most studied new markers. However, these assays have not been standardized until now, both from the laboratory and clinical point of view. In this review we summarize the evidence of the most studied aPL markers and their potential clinical significance in seronegative APS (SN-APS).

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Two Novel Technologies for the Detection of Anti-cardiolipin and Anti β2–Glycoprotein Antibodies in the Real Life: Chemiluminescent in Comparison to the Addressable Laser Bead Immunoassays

Cited by 8 publications

References 23 publications

Semiquantitative interpretation of anticardiolipin and antiβ2glycoprotein I antibodies measured with various analytical platforms: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

Semiquantitative interpretation of anticardiolipin and antiβ2glycoprotein I antibodies measured with various analytical platforms: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

Laboratory Diagnosis of Antiphospholipid Syndrome: Insights and Hindrances

Current Promising Biomarkers and Methods in the Diagnostics of Antiphospholipid Syndrome: A Review

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