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

被引：0

作者：

Zigon, Polona ^{[1
,2
]}

Bostic, Nika ^{[1
,3
]}

Ambrozic, Ales ^{[1
]}

Rotar, Ziga ^{[1
,4
]}

Blokar, Elizabeta ^{[1
]}

Ogric, Manca ^{[1
]}

Cucnik, Sasa ^{[1
,3
]}

机构：

[1] Univ Med Ctr Ljubljana, Dept Rheumatol, Vodnikova Cesta 62, Ljubljana 1000, Slovenia

[2] Univ Primorska, FAMNIT, Koper, Slovenia

[3] Univ Ljubljana, Fac Pharm, Ljubljana, Slovenia

[4] Univ Ljubljana, Fac Med, Ljubljana, Slovenia

来源：

CLINICAL CHEMISTRY AND LABORATORY MEDICINE | 2025年 / 63卷 / 01期

关键词：

antiphospholipid syndrome; anticardiolipin; anti-beta; 2GPI; classification criteria; DEFINITE ANTIPHOSPHOLIPID SYNDROME; INTERNATIONAL CONSENSUS STATEMENT; LUPUS ANTICOAGULANT; EUROPEAN-FORUM; ANTIBODIES; WORKSHOP; CHILDREN; UPDATE; ASSAYS; RISK;

D O I：

10.1515/cclm-2024-0570

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

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-beta 2 glycoprotein I (anti-beta 2GPI) antibodies. We aimed to establish clinically important moderate/high thresholds for aCL and anti-beta 2GPI 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-beta 2GPI 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-beta 2GPI 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-beta 2GPI 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.

引用

页码：164 / 176

页数：13