In a recently released article in Pediatrics, a team of physicians and scientists, including lead authors Alyssa Shapiro and Jessica Anderson from Rice University, Houston TX, collaborated across continents to test a new point-of-care device that can quantify total serum bilirubin using just a few drops of blood (10.1542/peds.2021-053928). The device, called “BiliSpec”, was tested in a clinical study at two central hospitals in Malawi, the Queen Elizabeth Central Hospital, and the Kamuzu Central Hospital. This is a remarkable step forward in clinical care. Although jaundice is easily treated with ultraviolet light phototherapy, and phototherapy is increasingly available in low- and middle-income countries (LMICs). The biggest challenge in resource-poor settings is accurate identification of infants who need this treatment. Particularly with dark and varying skin tones, visual assessment may underestimate jaundice, and transcutaneous bilirubinometry may overestimate jaundice, both leading to inappropriate or missed care. The authors point out that in the first week of life, neonatal jaundice resulting from hyperbilirubinemia is the 7th most common cause of neonatal death worldwide, with infants in resource-poor settings most affected.
In this clinical study, 456 neonates were enrolled, from whom 582 blood samples were collected. After exclusion for underfills and other errors, bilirubin samples from approximately 1/3 of neonates (n=149) were allocated to a “training set” which was used to train an algorithm for the device, and samples from the remaining 2/3 of neonates (n=236) were allocated to a “validation set” which was used for comparison to standard laboratory reference and a commercially available transcutaneous bilirubin device. The BiliSpec device itself, pictured in the article, requires a clinician to add a few drops of whole blood to a disposable strip, insert the strip into a reusable plastic tray, and place it in the reader. The strip is sealed in with an adhesive flap, plasma is separated from whole blood and flows into nitrocellulose, where the BiliSpec reader measures light transmission and produces a quantitative total serum bilirubin result in less than one minute.
The authors walk us through the entire process of device testing in a way that non-engineers can understand. You will learn how a team of scientists, engineers and clinicians work to bring a new device to the clinical world and will share in their challenges and successes. It’s a side of medicine most of us don’t know a lot about, and this article makes the reader an armchair participant! This ground-breaking work opens up a world of possibilities and hope for jaundiced neonates in LMICs –i.e., timely diagnosis and treatment of hyperbilirubinemia that will truly save lives.
