Background: The objective of this evaluation was to determine the analytical and clinical performance of the AFIAS point-of-care (POC) Tn-I Plus assay (Boditech Med Inc).
Design and methods: Limit of detection (LOD), limit of quantification (LOQ), repeatability, reproducibility, inter- and intra-individual CV were evaluated using the CLSI guidelines. The study was also designed to estimate the 99th percentile upper reference limit (URL) and to assess the diagnostic sensitivity and specificity.
Results: The precision repeatability CVs were 6.7-8.5% and reproducibility was 7.5-7.6%. The LOD and LOQ were consistent with the manufacturer's specified values of 0.010 ng/mL and 0.030 ng/mL, respectively. The 99th percentile URLs for males (aged 18-75 years) and females (aged 17-65 years) in serum were 0.0300 ng/mL (7.8% CV) and 0.0239 ng/mL (9.4% CV) respectively. Overall 99th percentile URL was 0.0296 ng/mL (8.2% CV). For the overall apparently healthy population, the percentage of measurable cardiac troponin I (cTn-I) values below the 99th percentile (i.e. 0.0296 ng/mL) and above the assay's LOD (= 0.010 ng/mL) was 47,68% (391/820 samples). The diagnostic sensitivity and specificity were 100% with 95% CI (97% - 100%) and 95.2% with 95% CI (93.6% - 96.5%), respectively. No significant differences were observed for the diagnosis of acute myocardial infarction (AMI) between AFIAS Tn-I plus and Abbott ARCHITECT High Sensitive Troponin-I.
Conclusion: The clinical performance of AFIAS Tn-I Plus assay for AMI is comparable to the established Abbott ALINITY STAT High Sensitive Troponin-I. This assay is suitable for routine use in clinical laboratories.
Keywords: Cardiac troponin I; analytical evaluation; clinical performance; point-of-care testing.