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

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.

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.

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.

The TriageTrue assay performed as reported in the package insert. The assay characteristics offer acceptable performance for use within the intended medical settings.