Abstract

A New Platform for Point-of-Care Testing of Cardiac Biomarkers Meeting Current Guidelines

Eloisa Lopez-Calle, Research & Development Line Manager & Development Lead, Roche Diagnostics GmbH

Cardiovascular diseases, such as acute myocardial infarction (AMI) and heart failure (HF), are the leading cause of death globally. A rapid and accurate diagnosis of these diseases is crucial for the immediate initiation of the treatment for the patients; and biomarkers, such as troponin and NT-proBNP, received the highest clinical guideline recommendation for that use. The measurement of these biomarkers with point-of-care (POC) devices has the unique benefits to (i) reduce the turn-around-time compared to laboratory testing, by avoiding the time-consuming process of sample transportation and pre-analytics (plasma/serum generation), (ii) to use it in the pre-hospital, ambulance settings, and (iii) to rule-out AMI/HF faster, thus allowing an improved flow of patients through the emergency department. Today, however, only few of the commercially available POC-systems show a guideline-compliant analytical performance for troponin testing, which is a recommended imprecision (coefficient of variation, CV) of <10% at the clinical cutoff, given as the 99th percentile upper reference limit of a healthy population.  We have developed an easy-to-use and portable prototype platform for the POC-testing of cardiac troponin T (cTnT) and NT-proBNP using a 30 µL whole blood sample with a time-to-result of 12 minutes or less. The immunoassay is run in a ready-to-use disposable cartridge with fully integrated reagents. After sample application of whole blood, plasma is generated by centrifugation, followed by incubation with immuno-reagents and washing. Finally, the fluorescence is measured, followed by calculating the biomarker amount. This presentation shows features of the new, CLIA-waivable platform matching with POC settings as well as the proof-of-concept for the guideline-compliant determination of cTnT and NT-proBNP with lab-like performance (cTnT: 3.8% as CV at the cutoff (14 ng/L), 6.8 ng/L as functional sensitivity (CV<10%), 8300 ng/L as upper-end measuring range; NT-proBNP:  4.1% as CV at 125 pg/mL-cutoff, 23 pg/mL as functional sensitivity, upper-end measuring range: 17000 pg/mL; excellent correlation of both assays with the commercial Elecsys® tests, hs-TnT 5th Gen. and proBNP II).