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Multicenter Comparison of Seven 25Oh Vitamin D Automated Immunoassays / Multicentrično Poređenje Sedam Automatizovanih Imunoeseja Za 25Oh Vitamin D

2014; De Gruyter; Volume: 34; Issue: 3 Linguagem: Croata

10.2478/jomb-2014-0054

1452-8258

Giuseppe Lippi, Gian Luca Salvagno, Antonio Fortunato, Mariella Dipalo, Rosalia Aloe, Giorgio Da Rin, Davide Giavarina,

Adrenal Hormones and Disorders

The measurement of 25OH vitamin D continues to grow in clinical laboratories. The aim of this multi-center study was to compare the results of seven automated commercial immunoassays with a reference HPLC technique.One hundred and twenty consecutive outpatient serum samples were centrifuged, divided in aliquots, frozen and shipped to the participating laboratories. 25OH Vitamin D was measured with a reference HPLC system and with seven automated commercial immunoassays (Roche Cobas E601, Beckman Coulter Unicel DXI 800, Ortho Vitros ES, DiaSorin Liaison, Siemens Advia Centaur, Abbott Architect i System and IDS iSYS).Compared to the reference method, the regression coefficients ranged from 0.923 to 0.961 (all p<0.001). The slope of Deming fit ranged from 0.95 to 1.06, whereas the intercept was comprised between -15.2 and 9.2 nmol/L. The bias from the reference HPLC technique varied from -14.5 to 8.7 nmol/L. The minimum performance goal for bias was slightly exceeded by only one immunoassay. The agreement between HPLC and the different immunoassays at 50 nmol/L 25OH Vitamin D varied between 0.61 and 0.85 (all p<0.001). The percentage of samples below this cut-off was significantly different with only one immunoassay.The excellent correlation with the reference HPLC technique attests that all seven automated immunoassays may be reliably used for routine assessment of 25OH-D in clinical laboratories. The significant bias among the different methods seems mostly attributable to the lack of standardization and calls for additional efforts for improving harmonization of 25OH-D immunoassays.Merenje 25OH vitamina D sve se češće obavlja u kliničkim laboratorijama. Cilj ove multicentrične studije bio je da se rezultati sedam automatizovanih komercijalnih imunoeseja uporede sa referentnom tehnikom HPLC.Sto dvadeset uzoraka seruma od uzastopnih pacijenata koji su posetili kliniku centrifugirano je, podeljeno u alikvote, smrznuto i poslato laboratorijama koje su učestvovale u istraživanju. Nivo 25OH vitamina D meren je pomoću referentnog sistema HPLC i pomoću sedam automatizovanih komercijalnih imunoeseja (Roche Cobas E601, Beckman Coulter Unicel DXI 800, Ortho Vitros ES, DiaSorin Liaison, Siemens Advia Centaur, Abbott Architect i System i IDS iSYS).U poređenju sa referentnim metodom, koeficijenti regresije kretali su se između 0,923 i 0,961 (svuda p<0,001). Nagib za Demingovu regresiju kretao se od 0,95 do 1,06, dok je kriva obuhvatila područje između −15,2 i 9,2 nmol/L. Odstupanje od referentne tehnike HPLC kretalo se od −14,5 do 8,7 nmol/L. Minimalni domet za odstupanje blago je prešao samo jedan imunoesej. Slaganje između HPLC i različitih imunoeseja pri koncentraciji od 50 nmol/L 25OH vitamina D variralo je između 0,61 i 0,85 (svuda p<0,001). Procenat uzoraka ispod ove cut-off vrednosti značajno se razlikovao samo za jedan imunoesej.Odlična korelacija sa referentnom tehnikom HPLC potvrđuje da se svih sedam automatizovanih imunoeseja mogu sa sigurnošću koristiti za rutinsko određivanje nivoa 25OH-D u kliničkim laboratorijama. Značajno odstupanje između različitih metoda po svoj prilici se može uglavnom pripisati nedostatku standardizacije i zahteva dodatne napore kako bi se popravila harmonizacija imunoeseja za 25OH-D.