Evidence map›Paper›PMID 42388243›Full record

ArticleJournal of rheumatic diseases2026

Comparative evaluation of chemiluminescent immunoassay and radioimmunoassay for the detection of anti-double-stranded DNA antibodies.

María Dolores Martín-Martínez, Gema García-de la Rosa, Juan De Castro-Córdova

Abstract read
In one paragraph

Article in Journal of rheumatic diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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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.

2 · The registry

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3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

María Dolores Martín-MartínezDepartment of Clinical Analysis Laboratory, Nuestra Señora de Candelaria University Hospital, Santa Cruz de Tenerife, Spain.ORCID https://orcid.org/0000-0001-5588-3478
Gema García-de la RosaDepartment of Clinical Analysis Laboratory, Nuestra Señora de Candelaria University Hospital, Santa Cruz de Tenerife, Spain.ORCID https://orcid.org/0000-0003-0976-2653
Juan De Castro-CórdovaDepartment of Clinical Analysis Laboratory, Nuestra Señora de Candelaria University Hospital, Santa Cruz de Tenerife, Spain.ORCID https://orcid.org/0009-0006-3846-3782

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: Anti-double-stranded DNA antibodies are essential biomarkers for diagnosing and monitoring systemic lupus erythematosus. Given the logistical limitations of the Farr radioimmunoassay (RIA), this study aimed to determine whether chemiluminescent immunoassay (CLIA) can serve as a suitable replacement in routine practice. Methods: A total of 807 serum samples were analyzed by CLIA and RIA. Quantitative agreement was evaluated with Spearman's correlation, Passing-Bablok regression, and Bland-Altman analysis. Qualitative concordance and diagnostic performance were assessed using contingency tables, Cohen's kappa, prevalence- and bias-adjusted kappa (PABAK) and receiver operating characteristic (ROC) curves. Manufacturer thresholds guided binary classification, with the Youden index used to optimize the CLIA cut-off. Results: The correlation between CLIA and RIA was weak but statistically significant (p=0.108, p=0.002). Passing-Bablok regression was not feasible due to distributional constraints. Bland-Altman analysis revealed a mean difference of 14.16 IU/mL with wide limits of agreement (-87.05 to 115.37 IU/mL), indicating poor quantitative agreement. Cohen's kappa was 0.365, while PABAK was 0.812. CLIA showed low sensitivity (45%) but high specificity (94%) relative to RIA. ROC analysis yielded an area under the curve of 0.719, with an optimal diagnostic cut-off of 19.15 IU/mL, resulting in a modest gain in sensitivity (45% to 57%) accompanied by a decline in specificity (94% to 86%). Overall, a discordance rate of 9% was observed between methods. Conclusion: CLIA cannot replace RIA without compromising diagnostic accuracy. Despite its operational advantages and high specificity, the limited sensitivity, quantitative discordance, and risk of misclassification at low titers highlight the importance of threshold recalibration and clinical context.

Indexed as

Anti-DNA antibodiesChemiluminescent immunoassayRadioimmunoassaySensitivity and specificitySystemic lupus erythematosus

Identifiers

PMID42388243
PMCPMC13318807

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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.