Shapiro Alyssa, Mtenthaonga Prince, Mjumira Rowland, Reuben Margaret, Samuel Ayodele, Bond Meaghan, Carns Jennifer, Schwarz Richard, Johnston Ryan, Mangwiro Lucky, Odedere Opeyemi, Miros Robert, McHugh Sean, Kawaza Kondwani, Dube Queen, Ezeaka Chinyere, Richards-Kortum Rebecca
Department of Bioengineering, Rice University, Houston, Texas, United States of America.
Rice360 Institute for Global Health Technologies, Rice University, Houston, Texas, United States of America.
PLOS Glob Public Health. 2023 Aug 8;3(8):e0002262. doi: 10.1371/journal.pgph.0002262. eCollection 2023.
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 < 60% and HCT ≥ 60%, and for samples with low and intermediate DB levels; the samples with high DB levels had wider 95% limits of agreement (-4.50 to +3.03 mg/dL). Error grid analysis shows that 96.9% of samples measured with BiliDx would have resulted in the same clinical decision as the reference standard. This performance is comparable to previous results that used a handmade two-dimensional strip. Additionally, error grid analysis shows that all 20 samples with high DB levels would have resulted in the same clinical decision as the reference standard. This evaluation supports the use of BiliDx lateral flow cassettes to provide accurate point-of-care measurements in low-resource settings.
新生儿黄疸是全球发病和死亡的重要原因，低收入和中等收入国家出生的新生儿负担过重。我们之前开发了一种低成本的即时检测系统，用于测量新生儿的总血清胆红素（TSB）。该设备在检测和监测黄疸方面很有效；然而，一次性试纸条难以大规模生产。在此，我们报告一种名为BiliDx的新型侧向流动检测卡设计，它采用传统制造技术进行了大规模生产。我们在尼日利亚和马拉维的地点评估了BiliDx的性能。侧向流动试纸条由血浆分离膜、硝酸纤维素和塑料检测卡组成。与参考标准TSB相比，我们在尼日利亚和马拉维的两家医院评估了试纸条和读数器的性能。我们还评估了高直接胆红素（DB）和高血细胞比容（HCT）样本的性能。我们从758名新生儿中收集了1144份样本（TSB范围为0.2至45.9mg/dL）。验证组中BiliDx测量的平均偏差为+0.75mg/dL，95%的一致性界限为-2.57至4.07mg/dL。HCT<60%和HCT≥60%的样本以及低和中等DB水平的样本的平均偏差和一致性界限具有可比性；高DB水平的样本95%的一致性界限更宽（-4.50至+3.03mg/dL）。误差网格分析表明，用BiliDx测量的96.9%的样本会得出与参考标准相同的临床决策。该性能与之前使用手工二维试纸条的结果相当。此外，误差网格分析表明，所有20份高DB水平的样本都会得出与参考标准相同的临床决策。该评估支持使用BiliDx侧向流动检测卡在资源匮乏地区提供准确的即时检测测量。
