Shapiro, AlyssaAnderson, JessicaMtenthaonga, PrinceKumwenda, WatsonBond, MeaghanSchwarz, RichardCarns, JenniferJohnston, RyanDube, QueenChiume, MsandeniRichards-Kortum, Rebecca2022-09-012022-09-012022Shapiro, Alyssa, Anderson, Jessica, Mtenthaonga, Prince, et al.. "Evaluation of a Point-of-Care Test for Bilirubin in Malawi." <i>Pediatrics,</i> 150, no. 2 (2022) American Academy of Pediatrics: https://doi.org/10.1542/peds.2021-053928.https://hdl.handle.net/1911/113169OBJECTIVES: BiliSpec is a low-cost spectrophotometric reader and disposable paper-based strip to quantify total serum bilirubin from several blood drops. This study was a prospective evaluation of BiliSpec in 2 neonatal wards in Malawi compared with a reference standard bilirubinometer over a large range of bilirubin and hematocrit levels. METHODS: The accuracy of BiliSpec and a transcutaneous bilirubinometer were compared with the reference standard of spectrophotometry for 475 blood samples collected from 375 subjects across a range of total serum bilirubin concentrations from 0.0 to 33.7 mg/dL. The development of error grids to assess the clinical effects of measurement differences is reported. RESULTS: BiliSpec was found to have a mean bias of −0.48 mg/dL and 95% limits of agreement of −5.09 mg/dL to +4.12 mg/dL. Results show 90.7% of BiliSpec measurements would have resulted in the same clinical decision as the reference standard, whereas 55.0% of transcutaneous bilirubin measurements would have resulted in the same clinical decision as the reference standard. CONCLUSIONS: This evaluation supports use of BiliSpec to provide accurate, low-cost, point-of-care bilirubin measurements in low-resource hospitals. Future work is needed to evaluate BiliSpec among a larger number of users.engThis work is licensed under a Creative Commons Attribution 4.0 International License .Journal articlepeds_2021053928https://doi.org/10.1542/peds.2021-053928