Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection

Ogrič, Manca (avtor), Švec, Tinka (avtor), Mrak Poljšak, Katjuša (avtor), Žigon, Polona (avtor), Hočevar, Alojzija (avtor), Čučnik, Saša (avtor)

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.

• Jezik: Angleški jezik
• Ključne besede: antineutrophil cytoplasmic antibodies, ANCA, proteinase 3, PR3, myeloperoxidase, MPO, ANCA-associated vasculitis, AAV, chemiluminescent immunoassay, likelihood ratios, LRs
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: MF - Medicinska fakulteta ; FFA - Fakulteta za farmacijo
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2024
• Št. strani: Str. 682–689
• Številčenje: Vol. 62, iss. 4
• PID: 20.500.12556/RUL-154819
• UDK: 616-097
• ISSN pri članku: 1437-4331
• DOI: 10.1515/cclm-2023-0764
• COBISS.SI-ID: 169691907
• Datum objave v RUL: 04.03.2024

Gradivo je del revije

• Naslov: Clinical chemistry and laboratory medicine
• Skrajšan naslov: Clin. chem. lab. med.
• Založnik: De Gruyter, European Federation of Clinical Chemistry and Laboratory Medicine
• ISSN: 1437-4331
• COBISS.SI-ID: 680355

Licence

• Licenca: CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by/4.0/deed.sl
• Opis: To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: antinevtrofilna citoplazemska protitelesa, ANCA, proteinaza 3, PR3, mieloperoksidaza, MPO, vaskulitis, povezan z ANCA, AAV, kemiluminiscentni imunski test, razmerja verjetnosti, LR

Projekti

• Financer: ARRS - Agencija za raziskovalno dejavnost Republike Slovenije