Department of Biomedical Engineering, University of Houston, Houston, Texas, USA.
Department of Pediatrics, Section of Hematology-Oncology, Baylor College of Medicine, Houston, Texas, USA.
Sci Rep. 2017 Apr 3;7:45488. doi: 10.1038/srep45488.
The high cost, complexity and reliance on electricity, specialized equipment and supplies associated with conventional diagnostic methods limit the scope and sustainability of newborn screening for sickle cell disease (SCD) in sub-Saharan Africa and other resource-limited areas worldwide. Here we describe the development of a simple, low-cost, rapid, equipment- and electricity-free paper-based test capable of detecting sickle hemoglobin (HbS) in newborn blood samples with a limit of detection of 2% HbS. We validated this newborn paper-based test in a cohort of 159 newborns at an obstetric hospital in Cabinda, Angola. Newborn screening results using the paper-based test were compared to conventional isoelectric focusing (IEF). The test detected the presence of HbS with 81.8% sensitivity and 83.3% specificity, and identified SCD newborns with 100.0% sensitivity and 70.7% specificity. The use of the paper-based test in a two-stage newborn screening process could have excluded about 70% of all newborns from expensive confirmatory testing by IEF, without missing any of the SCD newborns in the studied cohort. This study demonstrates the potential utility of the newborn paper-based test for reducing the overall cost of screening newborns for SCD and thus increasing the practicality of universal newborn SCD screening programs in resource-limited settings.
传统诊断方法成本高、复杂，且依赖于电力、专业设备和耗材，这限制了在撒哈拉以南非洲和世界其他资源有限地区开展镰状细胞病（SCD）新生儿筛查的范围和可持续性。在这里，我们描述了一种简单、低成本、快速、无需设备和电力的基于纸张的测试方法的开发，该方法能够检测新生儿血液样本中的镰状血红蛋白（HbS），检测限为 2% HbS。我们在安哥拉卡宾达的一家产科医院的 159 名新生儿队列中验证了这种基于纸张的新生儿测试。使用基于纸张的测试进行新生儿筛查的结果与传统等电聚焦（IEF）进行了比较。该测试对 HbS 的检出率为 81.8%，特异性为 83.3%，对 SCD 新生儿的检出率为 100.0%，特异性为 70.7%。在两阶段新生儿筛查过程中使用基于纸张的测试，可以使大约 70%的新生儿无需进行昂贵的 IEF 确认性检测，而不会遗漏研究队列中的任何 SCD 新生儿。本研究表明，基于纸张的新生儿测试具有降低 SCD 新生儿筛查总成本的潜力，从而提高资源有限地区普遍开展新生儿 SCD 筛查计划的实用性。
