20.500.12556/RUL-154819 Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection Objectives: Antineutrophil cytoplasmic antibody (ANCA) testing assists clinicians diagnose ANCA-associated vasculitis (AAV). We aimed to verify and harmonize chemiluminescent immunoassays for the detection of myeloperoxidase (MPO)- and proteinase 3 (PR3)-ANCA. Methods: An in-house ELISA, a capture ELISA, and a chemiluminescent assay QUANTA Flash on a BIO-FLASH analyzer were used to detect MPO- and PR3-ANCA in sera from 39 patients with AAV, 55 patients with various non-AAV, and 66 patients with connective tissue diseases. The results of the assays were evaluated, and their clinical performance was assessed. The precision and linearity of the QUANTA Flash assays were determined, and likelihood ratios (LRs) for AAV at diagnosis were calculated. Results: The precision and linearity of the QUANTA Flash assays were confirmed. Overall agreement between 97.5 and 98.8 % and Cohen’s kappa coefficients between 0.861 and 0.947 were observed for the results of the QUANTA Flash assays and ELISAs. The diagnostic sensitivity, specificity, and ROC analysis of the assays for AAV were statistically similar (in-house ELISA 89.7 %, 95.0 %, and 0.937; capture ELISA 92.3 %, 98.3 %, and 0.939; and QUANTA Flash 89.7 %, 95.9 %, and 0.972). For the QUANTA Flash assay results, the interval-specific LRs for AAV at diagnosis were: 0–8 CU had LR 0.08, 8–29 CU had LR 1.03, 29–121 CU had LR 7.76, 121–191 CU had LR 12.4, and >191 CU had LR ∞. Conclusions: The QUANTA Flash MPO and PR3 assays provide precise and consistent results and have comparable clinical utility for AAV. The calculated LRs were consistent with published LRs, confirming the utility of LRs for harmonization of ANCA results. antineutrophil cytoplasmic antibodies ANCA proteinase 3 PR3 myeloperoxidase MPO ANCA-associated vasculitis AAV chemiluminescent immunoassay likelihood ratios LRs antinevtrofilna citoplazemska protitelesa ANCA proteinaza 3 PR3 mieloperoksidaza MPO vaskulitis povezan z ANCA AAV kemiluminiscentni imunski test razmerja verjetnosti LR true false true Angleški jezik Slovenski jezik Članek v reviji 2024-03-04 12:00:15 2024-03-04 12:00:18 2024-03-05 03:48:12 0000-00-00 00:00:00 2024 0 0 Str. 682–689 iss. 4 Vol. 62 2024 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616-097 1437-4331 10.1515/cclm-2023-0764 169691907 10.1515_cclm-2023-0764_(1).pdf 10.1515_cclm-2023-0764_(1).pdf 1 E6E9F0F9C540CDE90EF8D1FF1CF177C2 6a7c585ef82726e744f3c76e4c4548d7a43e798c10d191df1ac7deb6b13412f2 823c27a3-da16-11ee-b2ad-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=181421 https://www.degruyter.com/document/doi/10.1515/cclm-2023-0764/html 1 6342d189-da16-11ee-b2ad-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=181420 Medicinska fakulteta Fakulteta za farmacijo 0 0 0