Background To validate the point of care testing (POCT) Trop-I analyzer and compare it with a central laboratory-based chemiluminescence immunoassay, in order to evaluate its performance for use in critical care areas. Moreover, for clinical decision-making, it is imperative to know the extent to which patient stratification will differ based on the analytic method being used. In particular, the aim of this study was to evaluate the analytical performance of the point-of-care analyzer and demonstrate the agreement with the central laboratory measurements in patients presenting to the emergency department (ED) with chest pain and suspected acute coronary syndrome (ACS). Methods This cross-sectional study was performed at the section of chemical pathology, department of pathology and laboratory medicine, the Aga Khan University (AKU), Karachi, from October to November 2017. Samples from patients and the quality control material of Trop-I were analyzed for imprecision, linearity, and method comparison on Advia Centaur (Siemens Diagnostics, CA, USA), and the AQT90 FLEX analyzer (Radiometer Medical ApS, Brønshøj, Denmark) with photometric detection at the section of chemical pathology, AKU. Statistical analysis was done using Microsoft Excel (Microsoft Corporation, Washington, United States) and EP Evaluator version 10.3.0.556 (Data Innovations, LLC, VT, US). Quantitative variables were represented in terms of mean ± SD. For precision, the computed SD was compared with allowable random error. Furthermore, Cohen's kappa was applied to observe the agreement between the two methods. Results The Trop-I Precision study on the POCT analyzer showed a coefficient of variation (CV) of 2.4% using a pooled patient sample with a mean Trop-I of 2.15 ± 0.05 ng/ml. Three standards ranging from 0.034 to 1.316 ng/ml were run in triplicate to verify accuracy and linearity. The allowable systematic error (SEa) was 10.0%. The maximum deviation for a mean recovery from 100% was 4.1%. All three of the mean recoveries were accurate and within the allowable error limits. The results were linear with slope 1.04, intercept 0.0. On a method comparison, Trop-I showed good agreement, yielding a kappa value of 0.95. Conclusion This study has validated the performance of a POCT Trop-I assay against a central laboratory immunoassay and found acceptable results. POCT assays for cTnI should be implanted in emergency settings to ensure the fast triage of patients with chest pain, as well as timely diagnosis.
Keywords: laboratory; myocardial infarction; point of care test; troponin; validation.