Lab Med Online.  2018 Oct;8(4):135-139. 10.3343/lmo.2018.8.4.135.

Performance Evaluation of the Point-of-Care Cardiac Troponin T Assay

• Kim YH
• Jeong TD
• Hong KS

• KMID: 2421003
• DOI: http://doi.org/10.3343/lmo.2018.8.4.135

Abstract

BACKGROUND
The point-of-care (POC) troponin T assay has been used in various clinical settings. Recently, a POC troponin T assay with an extended measurable range (40 ng/L-2,000 ng/L) was introduced. We aimed to evaluate the analytical performance of the Roche Cardiac POC Troponin T assay (POC TnT, Roche Diagnostics, Switzerland) using the cobas h 232 POC system.
METHODS
The repeatability and within-laboratory imprecision of the POC TnT assay were evaluated using the Roche Cardiac POC Troponin T level 2 control. Repeatability was also assessed using patient samples. Linearity of the POC TnT assay was evaluated using patient samples containing five different concentrations of troponin T. Performance of the Elecsys Troponin T high sensitivity assay (hs-TnT) was compared with that of the POC TnT assay using 40 patient samples.
RESULTS
The repeatability (%CV), and within-laboratory imprecision (%CV) using the level 2 control solution (mean troponin T, 441.6 ng/L) were 8.5% and 8.6%, respectively. The repeatability of patient samples containing 88.7 ng/L and 454.6 ng/L TnT was 7.5% and 7.2%, respectively. The POC TnT assay was confirmed to produce linear data between 54.0 ng/L and 1,347.7 ng/L. Relative to the hs-TnT assay, the Passing-Bablok linear regression equation (correlation coefficient) was y=0.8933x+6.24 (r=0.988). At a troponin T concentration of 40 ng/L, the estimated bias of the POC TnT assay was 1.972 ng/L (4.93%).
CONCLUSIONS
Our data suggest that the Roche Cardiac POC Troponin T assay is reliable in cases where POC troponin T testing is required.

Keyword

Performance; Point-of-care; Troponin T

MeSH Terms

Bias (Epidemiology)
Humans
Linear Models
Point-of-Care Systems*
Trinitrotoluene
Troponin T*
Troponin*
Trinitrotoluene
Troponin
Troponin T

Figure

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  Figure 1 Linearity of the Roche Cardiac POC Troponin T assay. The blue line represents linear regression of the data. The gray line depicts a theoretical line with a slope of 1.0 and a y-intercept of 0.

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  Figure 2 Comparison of troponin T assays using cobas e 411 and cobas h 232 analyzers. In the scatter plot, the light gray line depicts a theoretical line with a slope of 1.0 and a y-intercept of 0, and the dark gray line represents Passing-Bablok linear regression.

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