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SELECTBIO Conferences Point-of-Care Diagnostics & Biosensors Europe 2018

Eloisa Lopez-Calle's Biography

Eloisa Lopez-Calle, Head Assay Formats, Roche Diagnostics GmbH

Eloisa Lopez-Calle studied Chemistry at the University of Freiburg. She received her Ph.D. from the Institute for Organic Chemistry and Biochemistry, University of Freiburg, in the field of Organic Chemistry, synthesis of new small molecules for Medicinal Chemistry, in 1995. Afterwards she was medicinal chemist in the pharmaceutical industry (Hoechst Marion Roussel, Aventis) for one year. In her subsequent jobs she developed assays and assay reagents for high-throughput screening in drug discovery (Evotec, 9 years) and in-vitro-diagnostics (Analyticon, 2 years). 9 years ago she joined Roche Diagnostics, where she is currently heading the department Assay Formats for the early development new tests and corresponding platforms.

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

Wednesday, 6 June 2018 at 11:00

Add to Calendar ▼2018-06-06 11:00:002018-06-06 12:00:00Europe/LondonA New Platform for Point-of-Care Testing of Cardiac Biomarkers Meeting Current GuidelinesPoint-of-Care Diagnostics and Biosensors Europe 2018 in Rotterdam, The NetherlandsRotterdam, The

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).

Add to Calendar ▼2018-06-05 00:00:002018-06-06 00:00:00Europe/LondonPoint-of-Care Diagnostics and Biosensors Europe 2018Point-of-Care Diagnostics and Biosensors Europe 2018 in Rotterdam, The NetherlandsRotterdam, The