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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 R2 = 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.
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Details
1 Department of clinical research and education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden; Neonatal Unit at Sachs’ Children and Youth hospital, Stockholm, Sweden
2 Department of Women’s and Children’s Health, Karolinska Institutet, Stockholm, Sweden; Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden; Training and Research Academic Collaboration (TRAC) Sweden - Vietnam, Hanoi, Vietnam
3 Calmark Sweden AB, Stockholm, Sweden
4 Calmark Sweden AB, Stockholm, Sweden; Department of Medical Sciences, Biomedical Structure and Function, Uppsala University, Uppsala, Sweden
5 Neonatal Intensive Care Unit, Vietnam National Children’s Hospital, Hanoi, Vietnam; Research Institute for Child Health, Hanoi, Vietnam
6 Training and Research Academic Collaboration (TRAC) Sweden - Vietnam, Hanoi, Vietnam; Neonatal Intensive Care Unit, Vietnam National Children’s Hospital, Hanoi, Vietnam
7 Department of clinical research and education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden
8 Division of Nanobiotechnology, Department of Protein Science, Science for Life Laboratory, School of Engineering Sciences in Chemistry, Biotechnology and Health, KTH Royal Institute of Technology, Stockholm, Sweden