We evaluated the immunoassay for troponin I (TnI) which is now available on the integrated ARCHITECT analyzer ci8200 from Abbott. Coefficients of variation (CV) for between-day imprecision were 5.6%, 4.7% and 5.1% at TnI levels of 0.13 microg/l (mean of low control), 0.49 microg/l (medium control) and 11.2 microg/l (high control), respectively. All measurements of controls lay within pre-specified concentration ranges. The functional sensitivity at an imprecision level of 10% was found to be 0.04 microg/l, while the 99th percentile of the reference range derived from 130 apparently healthy subjects was determined as 0.02 microg/l with a corresponding CV of 15%. Thus, as none of the currently reported TnI tests the ARCHITECT STAT assay does not meet exactly the ESC/ACC consensus criteria for troponin testing but seems to perform better than many of the tests currently used in practice.
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Background: A novel handheld point-of-care high-sensitivity cardiac troponin I analyser has recently been introduced to the market. Evaluating its diagnostic performance against laboratory standards is imperative, given the variations in cardiac troponin levels across populations. This study compared the diagnostic performance between the point-of-care high-sensitivity cardiac troponin I assay (Siemens Healthineers Atellica VTLi) and a laboratory high-sensitivity cardiac troponin I assay (Abbott ARCHITECT STAT High Sensitive Troponin-I) performed using blood samples from various populations (overall, male, female, younger and older) of Chinese patients with chest pain.
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