Titus, Jitto

Abstract Object Transdermal biosensors may provide an alternative to conventional blood-based biomarker measurement. Our purpose was to determine the binary correlation between transdermal (Infrasensor™; RCE, Inc, Carlsbad, CA) and conventional blood-based measurements. Methods This was a secondary analysis from a previously published observational cardiac troponin I (cTnI) study performed to establish the upper reference level of cTnI, at 10 US hospitals. After obtaining informed consent, 2 cohorts of patients were enrolled: 1) those who completed a health assessment questionnaire and appeared healthy, and 2) those with a known elevated cTnI per the local hospital standard assay. All blood lab analyses were performed at the University of Maryland Medical Center, Baltimore, MD. Normal was defined as cTnI <53.48 ng/L (male) or 34.11 ng/L (female) using the Siemens Atellica IM assay (Siemens Medical Solutions, Mountain View, CA), NT-proBNP <450 pg/mL (>75 years) or <124 pg/mL (<75 years), creatinine >1.17 mg/dL (male) or >0.95 mg/dL (female), and HbA1c <6.4%. The Infrasensor was placed on the patient’s wrist for measurement and blood drawn for analysis at approximately the same time. Results Of 840 enrolled patients, the median (IQR) age was 46 (30,57), 416 (49.5%) were female, 10.36% Hispanic, 6.7% Asian, 12.9% African American, and 69.1% White. Elevated lab tests were 102 hscTnI’s, 156 NTproBNP’s, 37 HbA1C’s, and 163 creatinine’s. Significant binary correlations were found between all transdermal signals and the corresponding lab blood levels Conclusion Infrasensor transcutaneous measurement demonstrates similar results as that obtained from blood testing in the central laboratory. Capsule The Infrasensor (RCE, Inc, Carlsbad, CA, USA) is rapid point of care transcutaneous biomarker measurement device. This study evaluated its ability to provide qualitative results for troponin I, NTproBNP, creatinine, and HbA1c levels in 840 patients. Significant correlations were found between all transdermal signals and the corresponding binary lab blood levels.

Introduction: Early identification of Acute Myocardial Injury can prompt rapid triage and appropriate interventions to improve clinical outcomes. Over 10 million patients present at the ED with chest-pain, with the majority due to non-cardiac causes, resulting in unnecessary burdens for Emergency Departments (ED). An instant non-invasive method to measure cardiac troponin (cTn) would therefore be of great benefit. Identified need: All Guidelines recommend the use of high sensitivity (HS) cTn for the diagnosis of acute coronary syndromes (ACS). Current biochemical biomarker testing relies on labeling the cTn with turnaround times often an hour or more. Point-of-care solutions reduce the test time, but still depend on the proper handling of samples and blood processing techniques that could lead to difficulties. Tropsensor provides a non-invasive alternative to standard of care (SOC) hs-cTn measurements without the need for a blood draw. The molecular infrared spectroscopy-based transdermal device provides a cTn readout within 5 minutes and allows for serial measurements without any of the delays or complications of blood draws. Methods: A 26-patient (consented and IRB approved) study was conducted at Zuckerberg San Francisco General Hospital with recruitment based on ACS-related presenting symptoms at the ED. Wrist-worn Tropsensor was used on the patients while the corresponding troponin was determined using a high sensitivity (SOC) assay (Siemens ADVIA Centaur) via a blood draw. Results and conclusions: A Pearson’s correlation of 82% with the hs-cTnI was observed. AMI diagnosis sensitivity was 100%, Specificity=50%, PPV=81.8%, NPV=100% and accuracy=84.6%. The Tropsensor modality seems to provide data similar to that of a hs-cTn assay. If so, it would accelerate the assessment of patients presenting with chest pain. By not requiring a blood draw, the Tropsensor could provide a rapid, safe, standardized and reliable source for cTn while allowing bedside serial trending. It thus has the potential to streamline cardiac care workflow by ruling-out many non-cardiac patients and identifying those with high values who are at risk. Such an approach has the potential to facilitate appropriate patient triage towards early discharge of emergent treatment.