Analytical performance comparing siemens whole blood point of care Atellica VTLi to the central laboratory plasma Atellica IM high-sensitivity cardiac troponin I assays

Abstract

IntroductionThis study examined the analytical performance of a whole blood (WB) point of care (POC) hs-cTnI assay compared to a plasma central laboratory hs-cTnI assay in patients presenting with ischemic symptoms to a US emergency department. MethodsFresh WB specimens collected at 0 and 2 h from 1089 consecutive patients (2152 total from 1076 matched specimens) were analyzed for hs-cTnI using WB on POC Siemens Atellica VTLi assay and plasma on central laboratory Siemens Atellica IM assay. Concordances were determined based on concentrations ranging from < limit of detection (LoD), LoD to overall and sex specific 99th percentiles from both the IFCC manufacturer package inserts and Universal Sample Bank (USB) data, and > 99th percentiles. Method comparisons were calculated using Passing Bablok regression and Bland Altmann plots, and linear regression determined by Pearson correlation coefficient. ResultsBaseline concentration comparisons showed: POC VTLi < LoD 4–5 %, ≥ LoD 95 %; Atellica IM < LoD 5–7 %, and ≥ LoD 94–95 %. From the 2152 paired 0 and 2-hour samples, based on 99th percentiles, overall concordance was 91–92 % (kappa 0.72–0.77) and discordance 8 %. Passing Bablok regression analysis using 1924 specimens between LoD to 500 ng/L showed: slopes 0.469–0.490; y-intercepts 1.753–2.028; r values 0.631–0.817. Pearson correlation coefficient showed moderate to strong correlation strength, even with up to 53 % cTnI concentrations variance (Passing Bablok slopes) vs 27.0–40.1 % (Bland-Altmann plots). ConclusionsUp to 95 % of measured samples were > LoD for both the POC (Atellica VTLi) and central laboratory (Atellica IM) hs-cTnI assays. Moderate to strong concordance and correlation were observed between assays, despite up to 53 % variances in cTnI concentration.