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

• DOI: 10.1371/journal.pgph.0002262
• Publication Date: 2023-08-08T17:30:41Z
• Authors: 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; Rebecca Richards-...
• Keywords: Direct bilirubin; Point of care

Neonatal jaundice is an important cause of morbidity and mortality worldwide, neonates born in low middle-income countries bear a disproportionate burden. We previously developed low-cost, point-of-care system to measure total serum bilirubin (TSB) neonates. This device was effective at detecting monitoring jaundice; however, the disposable strips were difficult produce scale. Here, we report new lateral flow cassette design, called BiliDx, that produced scale using traditional manufacturing techniques. evaluated performance BiliDx sites Nigeria Malawi. The strip consists plasma separation membranes, nitrocellulose, plastic cassette. reader two hospitals located Malawi compared reference standard TSB. also assessed for samples with high direct (DB) hematocrit (HCT). collected 1,144 from 758 (TSB ranged 0.2 45.9 mg/dL). mean bias measurements validation set +0.75 mg/dL, 95% limits agreement -2.57 4.07 mg/dL. comparable HCT < 60% ≥ 60%, intermediate DB levels; levels had wider (-4.50 +3.03 Error grid analysis shows 96.9% measured would have resulted same clinical decision as standard. previous results used handmade two-dimensional strip. Additionally, error all 20 evaluation supports use cassettes provide accurate low-resource settings.