Analytical verification of the Atellica VTLi point of care high sensitivity troponin I assay

What is it about?

This study undertakes an independent verification of a point-of-care device for measuring troponin, a marker of heart muscle damage, concentrations in the blood. The device was the Siemens Atellica® VTLi high-sensitivity troponin I (hsTnI) analyser. We measured how repeatable the device produced results (precision), and its susceptibility to interference because of what else is in the blood sample. We compared its performance against four difference laboratory based devices measuring troponin using different methods. The results supported the earlier validation studies of the performance characteristics of the device. In particular the precision was low below a concentration known as the upper reference limit for females. The comparison with laboratory measurement methods showed robust correlations and agreement which are at least non-inferior to those of the laboratory measurement devices with each other. The device is deemed to be acceptable to proceed to clinical outcome studies and for eventual decision making, with potential for earlier safe discharge of Emergency Department patients.

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