Context for POC devices
Commenting on the meta-analysis but not involved in it, Rebecca Richards-Kortum, PhD, a professor of biomedical engineering at Rice University in Houston, noted that both devices were developed specifically to address needs in low-resource settings. “I don’t think the meta-analysis acknowledges this rationale sufficiently,” she said. “It feels like this paper is comparing apples to oranges and then criticizing the apples for not being oranges,” said Dr. Richards-Kortum, who helped develop the BiliSpec test.
John D. and Catherine T. MacArthur Foundation
Dr. Rebecca Richards-Kortum
Similarly, Anne S. Lee, MD, MPH, an associate professor of pediatrics at Brigham and Women’s Hospital in Boston, and not a participant in the meta-analysis, also stressed that POC devices are designed for scenarios where lab-based results are not widely available. “In a broad sense, the devices fill an important gap, both in low- and middle-income countries, as well as in the U.S. when laboratory capacity is not readily available,” said Dr. Lee. She was involved the development of the Bili-ruler icterometer, which proved to be diagnostically accurate in Bangladeshi newborns.
“Access to this technology is a critical way to address health disparities even in the U.S.,” Dr. Lee continued. “We have heard of the need for this technology from the Indian health services and Alaskan health services, where decisions are made to airlift a child based on a visual inspection alone.”
More broadly, however, cautioned Dr. Westenberg, the total allowable error and the permissible limits of uncertainty in neonatal bilirubin quantification need to be defined – irrespective of the method used. “Accurate measurement of bilirubin is difficult as has been demonstrated in so-called external quality assessment (EQA) programs that exist for laboratory-based bilirubin methods,” she said. “EQA programs for POC bilirubin devices that include a reference method as a gold standard may contribute to adaptation of the device and improving POC test imprecision.”
This work was supported by the Netherlands Organization for Health Research and Development. The authors had no conflicts of interest to disclose. Dr. Richards-Kortum and Dr. Lee have both been involved in the development of POC devices for assessing neonatal bilirubin levels.