Analytical and clinical comparison of different immunoassay systems for the detection of antiphospholipid antibodies

Montaruli, Barbara; Luna, Eduardo; Erroi, L.; Marchese, Cristiana; Mengozzi, Giulio; Napoli, P; Nicolò, Chiara; Romito, Antonio; Bertero, MT; Sivera, Piera; Migliardi, Marco

doi:10.1111/ijlh.12466

Cited by 19 publications

(24 citation statements)

References 20 publications

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“…Titers do correlate between systems, although the numerical values vary between test platforms 27,37 . Accordingly, it is nearly impossible to recommend a numeric value (it is >40 GPL/MPL 2 ) as general criterion for positivity.…”

Section: Anticardiolipin and Antibeta2‐glycoprotein I Antibodiesmentioning

confidence: 99%

Testing for antiphospholipid antibodies: Advances and best practices

Devreese

2020

Int J Lab Hematology

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The diagnosis of antiphospholipid syndrome (APS) relies on the detection of circulating antiphospholipid antibodies (aPL). Currently, lupus anticoagulant (LAC), anticardiolipin (aCL), and antibeta2-glycoprotein I antibodies (aβ2GPI) IgG or IgM are included as laboratory criteria if persistently present. Progress has been made on the standardization of tests as guidelines on LAC testing and immunological assays for aCL and aβ2GPI are published. However, LAC measurement remains a complicated procedure with many pitfalls and interfered by anticoagulant therapy. Solid-phase assays for aCL and aβ2GPI still show interassay differences. These methodological issues make the laboratory diagnosis of APS challenging. In the interpretation of aPL results, antibody profiles help in identifying patients at risk. Noncriteria aPL, such as antibodies against the domain I of beta2-glycoprotein (aDI) and antiphosphatidylserine-prothrombin (aPS/PT) antibodies have been studied in the last years and may be useful in risk stratification of APS patients. But, aDI and aPS/PT are not included in the current diagnostic criteria and testing in daily practice is not recommended as these antibodies have no added value in the diagnosis of APS. This review will focus on the technical aspects of the laboratory methods, the clinical relevance of assays and interpretation of aPL results in the diagnosis of APS. K E Y W O R D S anticardiolipin antibodies, antiphospholipid syndrome, anti-β2 glycoprotein I antibodies, guidelines, lupus anticoagulant

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Section: Anticardiolipin and Antibeta2‐glycoprotein I Antibodiesmentioning

confidence: 99%

Testing for antiphospholipid antibodies: Advances and best practices

Devreese

2020

Int J Lab Hematology

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“…This is evident by the different cut-off values of different brands of kits, and the wide range of results reported by labs during proficiency testing surveys [2,3,4,5]. Differences exist not only between various traditional, ELISA-based tests, but also between traditional tests and new technologies, such as chemiluminescent immunoassays (CIA) and addressable laser bead immunoassays (ALBIA) [6,7,8]. The analytical performance characteristics of these tests are often different from that of traditional technologies.…”

Section: Introductionmentioning

confidence: 99%

A Clinical Approach for Defining the Threshold between Low and Medium Anti-Cardiolipin Antibody Levels for QUANTA Flash Assays

2016

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Abstract:The threshold between low and medium antibody levels for anticardiolipin (aCL) and anti-β2 glycoprotein I antibodies (aβ2GPI) for the diagnosis of antiphospholipid syndrome (APS) remains a matter of discussion. Our goal was to create a protocol for determining the low/medium antibody cut-off for aCL antibody methods based on a clinical approach, and utilize it to establish the clinically-relevant low/medium threshold for QUANTA Flash aCL chemiluminescent immunoassay (CIA) results. The study included 288 samples from patients with primary APS (n = 70), secondary APS (n = 42), suspected APS (n = 36), systemic lupus erythematosus (SLE) without APS (n = 96) and other connective tissue diseases (n = 44). All samples were tested for IgG and IgM aCL antibodies with QUANTA Flash CIA, along with traditional enzyme-linked immunosorbent assays (ELISAs) (QUANTA Lite). The assay specific low/medium threshold for QUANTA Flash aCL IgG and IgM assays (i.e., the equivalent of 40 GPL and MPL units) was established as 95 and 31 chemiluminescent units (CU), respectively, based on clinical performance and comparison to QUANTA Lite ELISAs. Agreement between CIA and ELISA assay results improved substantially when the platform-specific low/medium antibody threshold was used, as compared to agreement obtained on results generated with the assay cutoff: Cohen's kappa increased from 0.85 to 0.91 for IgG aCL, and from 0.59 to 0.75 for IgM aCL results. This study describes a clinical approach for establishing the low/medium antibody threshold for aPL antibody assays, and successfully employs it to define 95 and 31 CU, respectively, as the low/medium cut point for QUANTA Flash aCL IgG and IgM results. This study can serve as a model for labs wishing to establish the appropriate low/medium aPL antibody threshold when implementing new aPL antibody assays.

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“…12,13 Mostly aCL and aβ2GPI antibodies are measured by ELISA, although chemiluminescence (CLIA) and fluorescence enzyme immunoassays (FEIA) have recently been introduced to the market. 16,17,[27][28][29][30][31][32][33] In most of the cases, fair to moderate agreement was found among different assays. 16,17,29,[31][32][33] de Moerloose et al 28 observed far higher agreement between three well-established commercial assays.…”

Section: Anticardiolipin and Anti-β2 Glycoprotein-i Antibodiesmentioning

confidence: 88%

“…Utilizing an automated system can improve reproducibility and reduce interlaboratory variation. [15][16][17][27][28][29][30][31][32][33] Willis et al 17 also analyzed that when the assays were calibrated using the recently developed reference IgG materials, the correlations for aβ2GPI antibodies were more improved.…”

Section: Anticardiolipin and Anti-β2 Glycoprotein-i Antibodiesmentioning

confidence: 99%

“…Poor assay reproducibility, variable sensitivity and specificity, and a lack of standardization and harmonization comprise methodological problems. 6,7,[15][16][17] But progress has been made and reference calibrators for aβ2GPI immunoassays was newly developed. 17 In this review, we want to give an overview of laboratory testing for APS with summary of recent international consensus guidelines for the detection of aPL.…”

Section: Introductionmentioning

confidence: 99%

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Laboratory Diagnosis of Antiphospholipid Syndrome

An¹,

Lim²,

Han³

2017

Clin Exp Thromb Hemost

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The diagnosis of antiphospholipid syndrome (APS) is essentially based on the detection of circulating antiphospholipid antibodies (aPL). Reading and interpretation of aPL profiles may be challenging and results of aPL should be interpreted in view of clinical context. The international diagnostic criteria of APS were developed and revised by international experts and societies, publishing international consensus guidelines on the recommended best practices for technical and performance requirements. Despite these attempts to produce consensus guidelines, some issues related to laboratory testing still remain unresolved. In this review, we want to give an overview of laboratory testing for APS with summary of recent international consensus guidelines for the detection of aPL. Also a brief review of prognostic significance of aPL profile and potential future diagnostic assay is presented.

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Analytical and clinical comparison of different immunoassay systems for the detection of antiphospholipid antibodies

Abstract: By guidelines, all laboratories are strongly advised to validate/verify the manufacturer's cutoff values. We recommend establishing low-positive, medium-/high-positive, and high-positive CliA IgG aCL and a-β2GpI ranges in order to help clinicians in the diagnosis and treatment of APS.

Cited by 19 publications

References 20 publications

Testing for antiphospholipid antibodies: Advances and best practices

Testing for antiphospholipid antibodies: Advances and best practices

A Clinical Approach for Defining the Threshold between Low and Medium Anti-Cardiolipin Antibody Levels for QUANTA Flash Assays

Laboratory Diagnosis of Antiphospholipid Syndrome

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