Abstract
AIMS: This study assessed the performance of a new fully automated immunoassay, ARCHITECT B.R.A.H.M.S procalcitonin (PCT), comparing the results with other commercial assays on routine clinical specimens. METHODS: At nine sites from eight countries, precision analysis was carried out on controls by ANOVA. Threshold and linearity were verified according to standard procedures. Comparison of ARCHITECT B.R.A.H.M.S PCT with the Cobas(®), LIAISON(®), VIDAS(®) and Kryptor(®) PCT assays was evaluated using Passing-Bablok and Deming regression analyses. RESULTS: The within-laboratory standard deviation and %CV across all sites ranged from 0.005 to 0.008 and 2.7 to 4.1; 0.040 to 0.212 and 2.1 to 11.7; 1.628 to 4.191 and 2.5-6.3 for the three control levels, respectively. The mean slope (linearity analysis) across all sites ranged from 0.85 to 1.03, with a mean y-intercept ranging from -6.15 to + 1.71 and a correlation coefficient ranging from 0.94 to 1.00. The LoB, LoD, and LoQ claims were verified. Deming regression analysis of 1116 plasma or serum samples with PCT results detected across a dynamic assay range of 0.02-100 μg/l using the ARCHITECT B.R.A.H.M.S PCT assay yielded results of r = 0.989 vs. Roche Cobas(®), r = 0.986 vs Kryptor(®) B.R.A.H.M.S, r = 0.987 vs BioMèrieux VIDAS(®) and r = 0.972 vs. Diasorin LIAISON(®), respectively. Concordance at cut-offs of 0.25 μg/l and 0.50 μg/l were 96.9% and 98.1% with Roche Cobas(®), 95.4% and 96.1% with B.R.A.H.M.S Kryptor(®), 93.8% and 98.4% with BioMèrieux VIDAS(®), and 92.7% and 93.9% with Diasorin LIAISON(®). CONCLUSIONS: Compared with other assays, ARCHITECT B.R.A.H.M.S PCT offers excellent precision and low-end sensitivity.