A-006 Evaluation of the ADVIA Centaur NT-proBNPII Assay Vs Standard-of-care Natriuretic Peptide Testing in the Emergency Department

Abstract

Abstract Background The Siemens Healthineers ADVIA Centaur® NT-proBNPII (PBNPII) assay* was developed for in vitro diagnostic use in the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP Immunoassay System. Siemens Healthineers performed a clinical study to evaluate the ADVIA Centaur XP PBNPII assay in an Emergency Department (ED) patient population. The study also involved collection of standard-of-care (SOC) natriuretic peptide (NP) results, either NT-proBNP or BNP. Objective To compare results from the ADVIA Centaur PBNPII assay in ED populations with SOC NP results and adjudicated diagnosis of heart failure. Methods 3128 subjects were enrolled from 30 ED sites. Blood was collected at time of enrollment for subsequent ADVIA Centaur PBNPII measurement; results from SOC NP testing were obtained from chart review. Available SOC testing was performed within 24 h of enrollment draw for all except four patients. Adjudication of acute HF (de novo or worsening) or non-acute HF was determined by an independent central adjudication panel of expert clinicians. Results Of the 3128 patients in the ED study, 1646 (52.6%) had an SOC BNP test performed, 1020 (32.6%) had an SOC NT-proBNP test performed, and 462 (14.8%) had neither. Agreement between the SOC NP results and PBNPII results was assessed based on concordance using cutoffs described in heart failure guidelines that include an indeterminate zone (1). For those tested with SOC NT-proBNP, there was 94.7% concordance, 5% partial concordance (indeterminate by one assay and positive or negative by the other), and 0.3% discordance. For those tested with SOC BNP, there was 73.8% concordance, 25.5% partial concordance, and 0.7% discordance. Agreement with adjudication was virtually identical for both the PBNPII assay and SOC PBNP at 63% concordance, 17% partial concordance, and 20% discordance. For those tested with SOC BNP, there was 63% concordance, 29.5% partial concordance, and 7.5% discordance, while in this same population the PBNPII assay had 67.8% concordance, 15.7% partial concordance, and 16.5% discordance. Conclusion Upon comparison of ADVIA Centaur PBNPII assay results to SOC NP testing in an ED population, Siemens Healthineers concludes that the ADVIA Centaur PBNPII assay performs similarly to commercial natriuretic peptide assays in routine use. These results agree with publications comparing diagnostic testing of NT-proBNP and BNP for suspected heart failure (2). *Disclaimer The products/features mentioned herein are not commercially available in all countries. Their future availability cannot be guaranteed.