| Title: | Establishment of ELISA-comparable moderate and high thresholds for anticardiolipin and anti-β2 glycoprotein I chemiluminescent immunoassays according to the 2023 ACR/EULAR APS classification criteria and evaluation of their diagnostic performance |
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| Authors: | ID Žigon, Polona (Author)
ID Boštic, Nika (Author)
ID Ambrožič, Aleš (Author)
ID Rotar, Žiga (Author)
ID Blokar, Elizabeta (Author)
ID Ogrič, Manca (Author)
ID Čučnik, Saša (Author) |
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| Files: |  PDF - Presentation file, download (1,19 MB)
MD5: 3C941B318F1C3CEFC25E85E7DEFD8897
 URL - Source URL, visit https://www.degruyter.com/document/doi/10.1515/cclm-2024-0570/html
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| Language: | English |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: |  UKC LJ - Ljubljana University Medical Centre
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| Abstract: | Objectives: Recently published 2023 ACR/EULAR APS classification criteria emphasize the importance of quantifying single-, double-, and triple-antiphospholipid antibody positivity, distinguishing between IgG and IgM isotypes, and delineating moderate/high levels of anticardiolipin (aCL) and anti-β2 glycoprotein I (anti-β2GPI) antibodies. We aimed to establish clinically important moderate/high thresholds for aCL and anti-β2GPI IgG/IgM chemiluminescent immunoassays (CLIA), in particular QUANTA Flash, comparable to our in-house ELISAs used for over two decades, and to evaluate their diagnostic performance. Methods: QUANTA Flash CLIA and in-house ELISAs were used to measure aCL and anti-β2GPI IgG/IgM. Moderate thresholds for QUANTA Flash CLIA were determined using a non-parametric approach, calculating a 99th percentile on serum samples from 139 blood donors, and by mirroring the diagnostic performance of in-house ELISA on 159 patient samples. Results: Thresholds for QUANTA Flash CLIA achieving diagnostic performance equivalent to in-house ELISAs were 40 CU for moderate and 80 CU for high levels for aCL and anti-β2GPI IgG and IgM. The assays showed good qualitative agreement, ranging from 76.10 to 91.19 %. When considering in-house ELISA results, 14 out of 80 (17.5 %) patients did not fulfill the new ACR/EULAR laboratory classification criteria, while 27 out of 80 (33.8 %) did not when considering QUANTA Flash CLIA results. Conclusions: We determined moderate and high thresholds for aCL and anti-β2GPI IgG and IgM detected with QUANTA Flash CLIA, aligning with long-established in-house ELISA thresholds. These thresholds are crucial for seamlessly integrating of the new 2023 ACR/EULAR classification criteria into future observational clinical studies and trials. |
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| Keywords: | anti-β2GPI, anticardiolipin, antiphospholipid syndrome, classification criteria |
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| Publication status: | Published |
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| Publication version: | Version of Record |
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| Year of publishing: | 2025 |
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| Number of pages: | str. 164-176 |
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| Numbering: | Vol. 63, iss. 1 |
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| PID: | 20.500.12556/DiRROS-24057  |
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| UDC: | 616-097 |
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| ISSN on article: | 1437-4331 |
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| DOI: | 10.1515/cclm-2024-0570 |
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| COBISS.SI-ID: | 203693059 |
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| Note: | Nasl. z nasl. zaslona;
Opis vira z dne: 5. 1. 2025;
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| Publication date in DiRROS: | 10.11.2025 |
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| Views: | 157 |
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| Downloads: | 75 |
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