Novel point-of-care panel for improved detection of critical illness in newborns

Syfte och mål

Approximately 4 million newborn die annually, and 50% of these deaths are caused by perinatal asphyxia and infections. A fast diagnosis and immediate treatment could prevent many of these mortalities. Calmark developed a unique product that can measure lactate dehydrogenase and bilirubin. This low-cost, easy handling and non-invasive device produces a test result within 4 minutes. This product is foreseen to provide earlier detection of serious illness, facilitating immediate treatment that can minimize the risk for irreversible illness and further save newborn lives.

Resultat och förväntade effekter

In a unique and novel platform, Calmark developed a filter membrane based point-of-care device that can measure the biomarkers LDH and bilirubin. This disposable performs horizontal separation of whole blood into blood plasma in less than 15s with a small sample volume. Both biomarkers are measured based on a colorimetric reaction on filter membranes and software analysis that correlates colour with biomarker concentration using a smartphone.

Upplägg och genomförande

Calmark´s product was developed successfully according with our initial plan. The bigger challenge we encountered was myeloperoxidase (MPO) assay optimization, thus LDH and bilirubin biomarkers were successfully incorporated into filters together with an extraordinary whole blood filtration method. This novel product was tested on patients in Sweden and Vietnam. Calmark´s created not only a product but a platform that can accommodate other biomarkers.