A rapid smartphone-based lactate dehydrogenase test for neonatal diagnostics at the point of care

Abstract

There is a growing recognition of the importance of point-of-care tests (POCTs) for detecting critical neonatal illnesses to reduce the mortality rate in newborns, especially in low-income countries, which account for 98 percent of reported neonatal deaths. Lactate dehydrogenase (LDH) is a marker of cellular damage as a result of hypoxia-ischemia in affected organs. Here, we describe and test a POC LDH test direct from whole blood to provide early indication of serious illness in the neonate. The sample-in-result-out POC platform is specifically designed to meet the needs at resource-limited settings. Plasma is separated from whole blood on filter paper with dried-down reagents for colorimetric reaction, combined with software for analysis using a smartphone. The method was clinically tested in newborns in two different settings. In a clinical cohort of newborns of Stockholm (n = 62) and Hanoi (n = 26), the value of R using Pearson’s correlation test was 0.91 (p < 0.01) and the R 2 = 0.83 between the two methods. The mean LDH (±SD) for the reference method vs. the POC-LDH was 551 (±280) U/L and 552 (±249) U/L respectively, indicating the clinical value of LDH values measured in minutes with the POC was comparable with standardized laboratory analyses.

Clinical, biological and electroencephalographic monitoring of newborns with neurological risk in the Neonatal Intensive Care Unit

“…Fluctuation of blood glucose concentration may be observed, hypoglycemia being the most common ( 4 , 16 , 48 ). LDH is a marker of cellular damage as a result of hypoxia-ischemia in affected organs ( 49 ). In neonatal HIE patients with a poor prognosis, significantly higher levels of LDH and serum creatine kinase (CK) are observed compared with neonatal HIE patients with a good prognosis ( 17 , 21 , 50 ).…”

Current Status and Future Perspectives of Lactate Dehydrogenase Detection and Medical Implications: A Review

“…Finally, POC systems are relatively inexpensive to manufacture and can be used as disposable device. These methods eliminate the need for complex laboratory facilities and complicated sample analyses, allowing for rapid, low-cost screening of large numbers of samples in resource-constrained medical settings [ 98 , 100 ]. However, the colorimetric method can only be applied to samples with relatively simple composition that are less susceptible to interference.…”

Biosensors for Personal Mobile Health: A System Architecture Perspective

“…Researchers have also demonstrated smartphone‐based spectrometers for quantification of the readout from colorimetric assays. Halvorsen et al developed a rapid smartphone‐based neonatal diagnostic test for measuring the levels of lactate dehydrogenase (LDH) from whole blood samples . The POC system consists of a disposable paper strip with dried‐down chemical reagents which produce the colorimetric readout.…”