Design and field evaluation of a lateral flow cassette device for point-of-care bilirubin measurement

Alyssa Shapiro, Prince Mtenthaonga, Rowland Mjumira, Margaret Reuben, Ayodele Samuel, Meaghan Bond, Jennifer Carns, Richard Schwarz, Ryan Johnston, Lucky Mangwiro, Opeyemi Odedere, Robert Miros, Sean McHugh, Kondwani Kawaza, Queen Dube, Chinyere Ezeaka and Rebecca Richards-Kortum

PLOS Global Public Health, 2023, vol. 3, issue 8, 1-17

Abstract: Neonatal jaundice is an important cause of morbidity and mortality worldwide, and neonates born in low and middle-income countries bear a disproportionate burden. We previously developed a low-cost, point-of-care system to measure total serum bilirubin (TSB) in neonates. This device was effective at detecting and monitoring jaundice; however, the disposable strips were difficult to produce at scale. Here, we report a new lateral flow cassette design, called BiliDx, that was produced at scale using traditional manufacturing techniques. We evaluated the performance of BiliDx at sites in Nigeria and Malawi. The lateral flow strip consists of plasma separation membranes, nitrocellulose, and a plastic cassette. We evaluated the performance of the strips and reader at two hospitals located in Nigeria and Malawi compared to reference standard TSB. We also assessed performance for samples with high direct bilirubin (DB) and high hematocrit (HCT). We collected 1,144 samples from 758 neonates (TSB ranged from 0.2 to 45.9 mg/dL). The mean bias of BiliDx measurements in the validation set was +0.75 mg/dL, and 95% limits of agreement were -2.57 to 4.07 mg/dL. The mean bias and limits of agreement were comparable for samples with HCT

Date: 2023
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pgph00:0002262

DOI: 10.1371/journal.pgph.0002262

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