Low-cost, handheld device reliably detects neonatal jaundice

Last Updated: 2017-12-13

By Marilynn Larkin

NEW YORK (Reuters Health) - Total serum bilirubin (TSB) levels measured with a battery-powered handheld device reliably detected neonatal jaundice in a small pilot study in Malawi, researchers say.

"Jaundice affects more than half of newborns, and clinicians know how to treat it," according to Dr. Rebecca Richards-Kortum of Rice University in Houston, Texas.

"The reason babies still die or suffer severe brain damage due to jaundice is because clinicians in places like sub-Saharan Africa do not have the tools to monitor and cure their patients," she said by email. "Low-cost treatments are beginning to become available in Africa, but current diagnostics are still far too expensive for most African hospitals."

"We created a rapid, low-cost, point-of-care bilirubin reader to address this," she explained. "It's called BiliSpec, and each test requires 2-3 drops of blood, can be completed in 1-2 minutes, and costs about five cents."

"This, our first clinical study, found that BiliSpec was very close to meeting Clinical Laboratory Improvement Amendments (CLIA) accuracy standards, and we have funding from USAID and others to conduct a larger multisite follow-up study," she said.

Dr. Richards-Kortum and her colleagues first assessed the device's performance using blood from normal volunteers spiked with differing amounts of bilirubin. The results correlated well with a reference laboratory bilirubinometer, they explain in Proceedings of the National Academy of Sciences USA, online December 4.

They then used the device to measure total serum bilirubin in 94 samples obtained by heel-prick from 68 neonates in a hospital in Malawi. The concentrations correlated well (r=0.996) with the CLIA reference standard, with concentrations ranging from 1.1 mg/dL to 23.0 mg/dL in the infants' samples.

"All samples measured by BiliSpec were within 3.0 mg/dL of the laboratory standard," the authors state.

Dr. Richards-Kortum said the bilirubin test is part of a set of 17 technologies, called the Newborn Essential Solutions and Technologies (NEST), that "could enable quality, comprehensive newborn care and save 500,000 newborn babies in Africa each year." The team is one of four finalists for a $100 million MacArthur Foundation grant and presented their final proposal to the foundation on December 11.

Dr. Jay Greenspan of Thomas Jefferson University and Nemours/A.I. duPont Hospital for Children in Philadelphia, commented, "Indirect hyperbilirubinemia (neonatal jaundice) is simple to diagnose and treat, which is why it is part of routine care of newborns in wealthy countries.

"Every baby is screened for jaundice, at least visually, and treatment is generally limited to exposing the babies to light," he explained in an email to Reuters Health. "If this jaundice is not treated, the results can be devastating, including cerebral palsy and death."

"This device is promising," he added. "The values the researchers obtained were favorably comparable to other methods."

"Is this a solution for the global problem? Maybe part of it," Dr. Greenspan continued. "Expense . . . will remain a challenge. This is just a pilot device, and the true expense to the end user must be assessed."

"The device must be easily powered and reliable," he stressed. "It can't malfunction because repairs will be difficult in the field."

"Most domestic hospitals screen with a light detector, described in the paper as a transcutaneous measurement," he observed. "This can tell a care provider if the skin is jaundice enough to warrant a blood test."

"I am not sure how this blood testing device would be operationalized in the global market, since visual inspection of dark skin is challenging and light sensors are not available," he noted. "Doing a blood test on every baby sequentially will be a challenge."

"My guess would be that a transcutaneous method would ultimately be the best process," Dr. Greenspan concluded. "Though you won't get a specific level, and monitoring therapy would be less than ideal, it would be enough to get babies treated and know when to stop therapy."

Rice University has submitted a patent application for the BiliSpec device. Several of the study authors are named on the application.

SOURCE: http://bit.ly/2BYEdjs

Proc Natl Acad Sci USA 2017.