Abstract
“Children are not tiny adults” is an adage commonly used in pediatrics to emphasize the fact that children often have different physiological responses to sickness and trauma compared to adults. However, despite widespread acceptance of this concept, diagnostic blood testing is an excellent example of clinical care that is not yet customized to the needs of children, especially newborns. Cumulative blood loss resulting from clinical testing does not typically impact critically ill adult patients, but can quickly escalate in children, leading to iatrogenic anemia and related comorbidities. Moreover, the tests prioritized for rapid, near-patient testing in adults are not always the most clinically relevant tests for children or newborns. This report describes the development of a digital microfluidic testing platform and associated clinical assays purposely curated to address current shortcomings in pediatric laboratory testing by using microliter volumes (<50 µL) of samples. The automated platform consists of a small instrument and single-use cartridges, which contain all reagents necessary to prepare the sample and perform the assay. Electrowetting technology is used to precisely manipulate nanoliter-sized droplets of samples and reagents inside the cartridge. To date, we have automated three disparate types of assays (biochemical assays, immunoassays, and molecular assays) on the platform and have developed over two dozen unique tests, each with important clinical application to newborns and pediatric patients. Cell lysis, plasma preparation, magnetic bead washing, thermocycling, incubation, and many other essential functions were all performed on the cartridge without any user intervention. The resulting assays demonstrate performance comparable to standard clinical laboratory assays and are economical due to the reduced hands-on effort required for each assay and lower overall reagent consumption. These capabilities allow a wide range of assays to be run simultaneously on the same cartridge using significantly reduced sample volumes with results in minutes.
Highlights
Clinical laboratory tests are an invaluable component of medical care that aid in both the diagnosis of disease and the evaluation of response to treatment
Due to the inherent simplicity in use of digital microfluidic (DMF) technology and flexibility in its operation, the platform is designed for use in multiple settings including a hospital laboratory, neonatal intensive care unit (NICU), physician’s office, or other distributed settings without ancillary laboratory equipment
Unbound bilirubin is regarded as the have demonstrated a DMF assay for creatinine, which is commonly tested in urine (Figure 5)
Summary
Clinical laboratory tests are an invaluable component of medical care that aid in both the diagnosis of disease and the evaluation of response to treatment. Cumulative blood loss from diagnostic testing can escalate quickly in critically ill patients resulting in iatrogenic anemia and need for transfusions, which are associated with higher risk of infection, donor erythrocyte injury, and other cardiac, vascular, and hemorrhagic complications [1,2,3,4]. In a multi-center study of 30 pediatric intensive care units (PICUs), 74% of critically ill children were anemic and the majority of daily blood loss was attributed directly to blood draws for diagnostic testing [5]. Packed red blood cell (PRBC) transfusions may lead to a host of complications such as acute lung injury, graft-versus-host disease [2], and increased in-hospital mortality of very low birth weight (VLBW)
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