Point-of-care high-sensitivity troponin-I analysis in capillary blood for acute coronary syndrome diagnostics

Abstract

Objectives: Patients with acute coronary syndrome (ACS) should be referred promptly to the hospital to reduce mortality and morbidity. Differentiating between low-risk and high-risk patients remains a diagnostic challenge. Point-of-care testing can contribute to earlier disposition decisions for patients excluded from ACS. This study describes the validation of the Atellica^® VTLi. Patient-side Immunoassay Analyzer for high-sensitivity troponin point-of-care (POC) analysis. (The Atellica VTLi is not available for sale in the USA. The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed).

Methods: A total of 152 patients with acute chest pain admitted at the cardiac emergency department (ED) were included in the study. Capillary blood was compared with a whole blood and plasma sample obtained by venipuncture. All samples were analyzed using the Atellica VTLi Patient-side Immunoassay Analyzer; in addition, plasma was analyzed by a central lab immunoassay analyzer.

Results: No significant difference was observed between venous whole blood vs. plasma analyzed by the Atellica VTLi Patient-side Immunoassay Analyzer. The difference between capillary blood and venous blood showed a constant bias of 7.1%, for which a correction factor has been implemented. No clinically relevant differences were observed for the capillary POC results compared to plasma analyzed with a standard immunoassay analyzer.

Conclusions: The Atellica VTLi Patient-side Immunoassay Analyzer for high-sensitivity troponin analysis shows equivalent results for all sample types, including capillary blood. No clinically relevant discordances were observed between capillary POC and central laboratory results. With additional studies, this could pave the way towards rapid testing of high-sensitivity troponin in the ambulance or the general practitioner's office without the need for hospitalization of patients with acute chest pain.

Keywords: acute coronary syndrome (ACS); cardiac markers; immunoassay; point-of-care; troponin.