Analytical Verification of a Point-of-Care High-Sensitivity Troponin I Assay

Abstract Background The QuidelOrtho TriageTrue® point-of-care (POC) high-sensitivity troponin I (hs-TnI) assay has been previously validated. We aimed to independently verify the assay’s analytical performance and concordance with other assays and to verify secondary POC devices. Methods Intra-assay precision: 5 whole blood samples spanning the measuring interval were analyzed up to 20 times in succession. Inter-analyzer and inter-lot precision studies were also carried out and a precision curve generated. Hemolysis was assessed by spiking 8 samples with concentrations from 2 to 320 ng/L with hemolysate. Concordance between 200 TriageTrue samples and one other hs-TnI POC and 4 laboratory analyzers was assessed by Pearson correlation and kappa statistics at the limit of quantitation and upper reference limit. Paired measurements from 9 samples between a primary verified device and 8 secondary devices were compared against prespecified difference limits. Results Intra-assay precision CVs were 25% and 12.2% at mean concentrations of 2.4 ng/L and 8.5 ng, respectively, and ranged from 2.8% to 15.9% at higher concentrations 10 ng/L. There was minimal interference by hemolysis up to 10 g/L, which exceeded the manufacturer’s claim of 1.96 g/L. Correlation coefficients were 0.89 to 0.99 with other assays with the exception of the Roche hs-TnT assay, where it was 0.79. These were similar to the laboratory assays. Of 116 comparisons with 8 secondary analyzers, all fell within acceptable limits. Conclusions The TriageTrue assay performed as reported in the package insert. The assay characteristics offer acceptable performance for use within the intended medical settings.