ArticleClinical chemistry and laboratory medicine2025
Comprehensive evaluation of antiphospholipid antibody testing methodologies in APS diagnosis: performance comparisons across assay systems and clinical subtypes.
Article in Clinical chemistry and laboratory medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
objectivesAntiphospholipid syndrome (APS) is an autoimmune disorder characterized by thrombosis and obstetric complications associated with antiphospholipid antibodies (aPLs). This study aimed to compare the diagnostic performance of six commercial assay systems for detecting aCL and aβ2GPI antibodies.
methodsSixty-three APS patients, 50 SLE patients, 67 disease controls, and 62 healthy controls were enrolled. aCL and aβ2GPI antibodies of IgA, IgG, and IgM isotypes were measured using six commercial platforms, including three ELISA-based systems and three CLIA-based systems. Inter-assay concordance was compared across all detection platforms, and ROC curve analysis was performed to evaluate and compare their diagnostic performance in APS.
resultsInter-assay concordance varied across platforms, with IgG isotypes showing the highest consistency and IgA exhibiting the lowest agreement. Overall, CLIA-based systems demonstrated superior classification performance compared to ELISA-based methods. The highest area under the curve (AUC) reached 0.811, with sensitivity and specificity up to 0.730 and 0.891, respectively. IgG isotypes demonstrated the best overall performance, while IgA and IgM showed greater variability. The inclusion of IgA modestly improved sensitivity in some systems, although this was sometimes accompanied by decreased specificity. LA-positive patients had higher aPL positivity rates than LA-negative ones, and aPL levels were higher in thrombotic vs. obstetric APS.
conclusionsSignificant variability exists among commercial aPL detection systems. CLIA-based methods provided better consistency and diagnostic accuracy than ELISA. The inclusion of IgA provided additional diagnostic value in identifying APS patients who tested negative for aCL and aβ2GPI of the IgG and IgM isotypes.
Indexed as
Identifiers
40569180What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.