Lactate Assay Application Using a New Comprehensive Bioelectronic System for Point-of-Care Applications

Abstract

Serum lactate is an important measurement taken in critical care settings for screening of lactic acidosis and as an indicator of sepsis. In addition, serial lactate testing provides essential information for evaluating therapy effectiveness and informing treatment decisions of critically ill patients at the point-of-care (POC). In this work, the performance of the Ohmx POC eDx Lactate test was evaluated and compared to the Nova Biomedical Lactate Plus Meter. This assay is introduced as the first test for a comprehensive bioelectronic POC instrument currently in development by Ohmx that will also offer procalcitonin and C-reactive protein tests for sepsis monitoring. Clinical sample testing shows an average recovery of 99% for measured sample lactate concentration relative to the Lactate Plus Meter for 60 samples. Correlation by Passing-Bablok regression yielded Lactate Plus = 1.03 Â Ohmx eDx + 0.22, r = 0.984 (n = 60; range of lactate values, 0.7-6.0 mmol/L). The lower limit of detection was 0.1 mmol/L. The lower and upper limits of quantification were 0.208 and 20 mmol/L, respectively. Intraday and total imprecision (% coefficient of variation) ranges from 5.7% to 9.1% across the assay range (0.2-20 mmol/L). These collective data clinically validate the Ohmx eDx Lactate assay and demonstrate the system's robust performance comparable to the Food and Drug Administration-cleared Lactate Plus Meter by Nova Biomedical.