(L-444) Enhancing Lactate Monitoring Efficiency

The goal of this project is to design, build, and validate a sophisticated diagnostic tool for rapidly quantifying the blood lactate levels. The technology development is based on the use of lactate dehydrogenase in conjunction with existing blood glucose testing devices. This device is expected to greatly enhance the precision, functionality, and usage of blood lactate monitoring for emergency room patients. By merging sensors, data processing algorithms, and user-friendly interfaces, this project aims to create a device that measures lactate level using a blood drop collecting test strip device analogous to that used for glucose monitoring and providing measurement within 2 minutes for lactate in units of mg/dL. We hypothesize that the development of an enhanced lactate test that combines a familiar test strip design with a robust sensor technology and advanced data processing algorithms will produce readings of lactate that are incredibly precise and reliable. We predict this technology will benefit ER nurses who rely on lactate monitoring for a variety of medical issues like sepsis and tissue ischemia.

Current models take 2-3min to calculate the lactate concentration. This prototype is expected to calculate blood lactate level in under 2 minutes. Collection of blood samples through capillary action using glucometer-like test strips that can be provided by a pin prick method. The test strip is a multi-layer design in the following order: base plastic layer, electrode layer with enzyme, hydrophilic channel layer, counter-reference electrode layer, and finally the top plastic layer. The reading using lactate dehydrogenase in the enzyme are compared to the output from the meter using standard dilutions of lactate in mock sample as to provide a means for calibration of the devices lactate level readings.

We expect the device will yield appropriate reading across the relevant desired range of lactate levels found to be clinically meaningful. Specifically, lactate concentrations above 2 mmol/L are regarded as elevated, those above 4 mmol/L as very high, and those surpassing 10 mmol/L as severe instances of sepsis or septic shock. It is expected that for valid device performance the lactate readings of the device to be within an accuracy of 0.5 mmol/L. For reliability measurement, we will validate using blood samples spiked with different levels of lactate from the range above as an indicator of the ability for the device to serve in evaluating lactate in a clinical setting. In conclusion, the development of this improved lactate meter has the potential to expedite lactate monitoring which may have a significant effect on sepsis prediction in the ER. This project sets the way for the development of an accurate and user-friendly lactate monitoring technology.

Research reported in this publication was supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under Award Number R25EB032766. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.