Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Department of Laboratory Medicine, Seegene Medical Foundation, Seoul, Republic of Korea.
J Clin Lab Anal. 2024 Aug;38(15-16):e25093. doi: 10.1002/jcla.25093. Epub 2024 Aug 21.
Neonatal jaundice (NNJ) affects a significant proportion of newborns globally, with an increased burden in low-resource settings. Effective health risk management of NNJ is hindered, particularly in resource-constrained environments, where early detection and treatment are challenging. The careSTART S1 Total Bilirubin Strip, a point-of-care testing (POCT) device based on a diazo-method, offers a potential solution by enabling onsite bilirubin measurement, thus, addressing the gap in early NNJ detection and management.
The current study evaluated the analytical performance of the careSTART S1 Total Bilirubin Strip for precision, linearity, method comparison, and lot-to-lot consistency following CLSI guidelines. For method comparison, 105 residual EDTA whole blood samples were analyzed with the careSTART S1 Total Bilirubin Strip and compared with reference measurements from the Roche Cobas c702 analyzer. Additionally, statistical analyses, including Passing-Bablok regression and Bland-Altman plots, were performed.
The careSTART S1 Total Bilirubin Strip showed allowable (<10%) within-laboratory imprecision of 2.5%-3.6% across all levels and demonstrated linearity over the range of 4.16-439.3 μmol/L. Method comparison revealed a constant negative bias with a mean bias -4.19 μmol/L. However, the 95% confidence interval (-7.10 to -1.28 μmol/L) of the bias is covered by the prespecified allowable bias of 8.3%, at medical decision point. Lot-to-lot variation ranged from 0.14%-6.49%, and was within the acceptable critical difference of 8.3%.
The careSTART S1 Total Bilirubin Strip provided accurate and reliable bilirubin measurements that could contribute to neonatal care in settings lacking central laboratory facilities.
新生儿黄疸（NNJ）在全球范围内影响着相当大比例的新生儿，在资源匮乏的环境中负担加重。有效的 NNJ 健康风险管理受到阻碍，特别是在资源有限的环境中，早期检测和治疗具有挑战性。careSTART S1 总胆红素条，一种基于重氮法的即时检测（POCT）设备，通过实现现场胆红素测量，提供了一种潜在的解决方案，从而解决了早期 NNJ 检测和管理方面的差距。
本研究根据 CLSI 指南评估了 careSTART S1 总胆红素条的分析性能，包括精密度、线性、方法比较和批间一致性。对于方法比较，使用 careSTART S1 总胆红素条分析了 105 份 EDTA 残留全血样本，并与罗氏 Cobas c702 分析仪的参考测量值进行比较。此外，还进行了统计学分析，包括 Passing-Bablok 回归和 Bland-Altman 图。
careSTART S1 总胆红素条在所有水平的实验室内部精密度允许值（<10%）为 2.5%-3.6%，并且在 4.16-439.3 μmol/L 范围内显示出线性。方法比较显示出恒定的负偏差，平均偏差为-4.19 μmol/L。然而，偏差的 95%置信区间（-7.10 至-1.28 μmol/L）在规定的允许偏差 8.3%内。批间变异范围为 0.14%-6.49%，在可接受的临界差值 8.3%内。
careSTART S1 总胆红素条提供了准确可靠的胆红素测量值，可在缺乏中央实验室设施的环境中为新生儿护理做出贡献。
