OBJECTIVES 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.

中文翻译：

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马拉维胆红素即时检测评估。

目标 BiliSpec 是一种低成本的分光光度读取器和一次性纸质试纸条，用于从几滴血中量化总血清胆红素。本研究是对马拉维 2 个新生儿病房中 BiliSpec 的前瞻性评估，并与参考标准胆红素计在大范围的胆红素和血细胞比容水平上进行了比较。方法 将 BiliSpec 和经皮胆红素计的准确性与分光光度法的参考标准进行比较，从 0.0 到 33.7 mg/dL 的总血清胆红素浓度范围内，从 375 名受试者中采集 475 份血液样本。报告了开发误差网格以评估测量差异的临床效果。结果发现 BiliSpec 的平均偏差为 -0.48 mg/dL，95% 的一致性极限为 -5.09 mg/dL 至 +4.12 mg/dL。结果显示 90。7% 的 BiliSpec 测量会导致与参考标准相同的临床决策，而 55.0% 的经皮胆红素测量会导致与参考标准相同的临床决策。结论 该评估支持使用 BiliSpec 在资源匮乏的医院提供准确、低成本、即时的胆红素测量。未来的工作需要在大量用户中评估 BiliSpec。