Evaluation of antiphospholipid antibody assays using latent class analysis to address the lack of a reference standard

Thaler, Markus; Bietenbeck, Andreas; Yin, Meng‐Xin; Steigerwald, Udo; Holmes, Andrew B.; Lindhoff-Last, Edelgard; Luppa, Peter B.

doi:10.1515/cclm-2016-0116

Cited by 2 publications

(6 citation statements)

References 45 publications

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“…The investigated samples constitute a subgroup of the samples employed in a recent study [22], i.e. only samples with a sufficient amount of sample volume were included in the present work.…”

Section: Methodsmentioning

confidence: 99%

“…only samples with a sufficient amount of sample volume were included in the present work. As such, 53 of the 63 APS patients and all 34 healthy controls of [22] were investigated in the present study.…”

Section: Methodsmentioning

confidence: 99%

“…Diagnostic performance of the LIA for criteria aPL was assessed by employing a LCA-derived “gold standard” calculated as described previously [22]. Briefly, in the context of this work, LCA assigns the observed test results to an unknown (“latent”) binary variable representing presence or absence of the respective antibody.…”

Section: Methodsmentioning

confidence: 99%

“…The underlying statistical model is expressed by a likelihood function. Provided at least three different tests have been performed on the respective antibody, maximizing this likelihood function enables estimation of its parameters [22]. As a result, sera were assigned to either the antibody-positive or -negative group in a way to yield the observed test outcomes with the highest probability.…”

Section: Methodsmentioning

confidence: 99%

“…Sensitivities and specificities for criteria-aPL were assessed using latent class analysis (LCA). We recently demonstrated [22], that LCA offers a statistically sound and innovative approach to explore the diagnostic performance of research biosensor assays for aPL detection [23, 24] despite the absence of proper reference material and method.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the sensitivity and specificity of a novel line immunoassay for the detection of criteria and non-criteria antiphospholipid antibodies in comparison to established ELISAs

et al. 2019

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Background Persistent antiphospholipid antibodies (aPL) constitute the serological hallmark of the antiphospholipid syndrome (APS). Recently, various new assay technologies for the detection of aPL better suited to multiplex reaction environments than ELISAs emerged. We evaluated the diagnostic performance of such a novel line immunoassay (LIA) for the simultaneous detection of 10 different aPL. Methods Fifty-three APS patients and 34 healthy controls were investigated for criteria (antibodies against cardiolipin [aCL], β2-glycoprotein I [aβ2-GPI]) and non-criteria aPL (antibodies against phosphatidic acid [aPA], phosphatidyl-choline [aPC], -ethanolamine [aPE], -glycerol [aPG], -inositol [aPI], -serine [aPS], annexin V [aAnnV], prothrombin [aPT]) IgG and IgM by LIA. Criteria aPL were additionally determined with the established Alegria (ALE), AcuStar (ACU), UniCap (UNI), and AESKULISA (AES) systems and non-criteria aPL with the AES system. Diagnostic performance was evaluated with a gold standard for criteria aPL derived from the results of the four established assays via latent class analysis and with the clinical diagnosis as gold standard for non-criteria aPL. Results Assay performance of the LIA for criteria aPL was comparable to that of ALE, ACU, UNI, and AES. For non-criteria aPL, sensitivities of the LIA for aPA-, aPI-, aPS-IgG and aPA-IgM were significantly higher and for aPC-, aPE-, aAnnV-IgG and aPC- and aPE-IgM significantly lower than AES. Specificities did not differ significantly. Conclusions The LIA constitutes a valuable diagnostic tool for aPL profiling. It offers increased sensitivity for the detection of aPL against anionic phospholipids. In contrast, ELISAs exhibit strengths for the sensitive detection of aPL against neutral phospholipids.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%