Pubblicazioni

Autori:

Danese, Elisa; Piona, Claudia; Rizza, Mariateresa; Tiziani, Elena; Pighi, Laura; Morotti, Elisa; Salvagno, Gian Luca; Mattiuzzi, Camilla; Maffeis, Claudio; Lippi, Giuseppe

Titolo:

A Comparative Evaluation of the Chemiluminescence Immunoassay and ELISA for the Detection of Islet Autoantibodies in Type 1 Diabetes

Anno:

2025

Tipologia prodotto:

Articolo in Rivista

Tipologia ANVUR:

Articolo su rivista

Lingua:

Inglese

Formato:

Elettronico

Referee:

Sì

Nome rivista:

DIAGNOSTICS

ISSN Rivista:

2075-4418

N° Volume:

15

Numero o Fascicolo:

13

Intervallo pagine:

1695-1695

Parole chiave:

CLIA, ELISA, GADA, IA-2A, ZnT8A, chemiluminescence immunoassay, islet autoantibody, type 1 diabetes mellitus

Breve descrizione dei contenuti:

Background: The early detection of type 1 diabetes (T1D) through screening for major islet autoantibodies is receiving increasing attention as a public health strategy, exemplified by the recent implementation of a pilot pediatric screening program in Italy. The transition from research-based screening to large-scale population initiatives needs automated and standardized assays that are capable of processing extensive sample volumes. Hence, this study aimed to evaluate the analytical performance and comparability of a fully automated chemiluminescence immunoassay (CLIA) compared to a conventional enzyme-linked immunosorbent assay (ELISA) for the detection of three classes of major islet antibodies-anti-GAD (GADA), anti-IA-2 (IA-2A), and anti-ZnT8 (ZnT8A). Methods: A total of 104 serum specimens were analyzed for each autoantibody using both ELISA (RSR and Medyzim, DYNES, DSX) and CLIA (MAGLUMI 800). Assay precision and linearity were assessed through intra-assay variability studies and dilution protocols. Methods agreement was evaluated with Passing-Bablok regression, Spearman's correlation, Bland-Altman analysis, and Cohen's kappa statistics. Results: The CLIA showed good precision and excellent linearity across clinically relevant concentration ranges of all islet antibodies. Correlation coefficients and categorical agreement between CLIA and ELISA were high (r > 0.96 and Cohen's kappa >0.8 for all), with ZnT8A exhibiting the highest concordance. However, proportional biases were found, as CLIA systematically underestimated GADA and ZnT8A levels, while overestimated IA-2A compared to the ELISA. Conclusions: The CLIA displayed satisfactory precision and agreement with ELISA for GADA, IA-2A, and ZnT8A detection. Our findings support the use of these automated immunoassays in large-scale population initiatives for diagnosing T1D, but we also highlight the need for further efforts to achieve better inter-assay harmonization.

Pagina Web:

https://www.mdpi.com/2075-4418/15/13/1695

Id prodotto:

146686

Handle IRIS:

11562/1166707

ultima modifica:

19 settembre 2025

Citazione bibliografica:

Danese, Elisa; Piona, Claudia; Rizza, Mariateresa; Tiziani, Elena; Pighi, Laura; Morotti, Elisa; Salvagno, Gian Luca; Mattiuzzi, Camilla; Maffeis, Claudio; Lippi, Giuseppe, A Comparative Evaluation of the Chemiluminescence Immunoassay and ELISA for the Detection of Islet Autoantibodies in Type 1 Diabetes «DIAGNOSTICS» , vol. 15 , n. 13 , 2025 , pp. 1695-1695

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