Laboratory of Toxicology, Department of Environmental Veterinary Sciences, Faculty of Veterinary Medicine, Hokkaido University, Kita 18 Nishi 9, Kita-ku, Sapporo, 060-0818, Japan.
Laboratory of Toxicology, Department of Environmental Veterinary Sciences, Faculty of Veterinary Medicine, Hokkaido University, Kita 18 Nishi 9, Kita-ku, Sapporo, 060-0818, Japan.
Chemosphere. 2021 May;271:129832. doi: 10.1016/j.chemosphere.2021.129832. Epub 2021 Feb 2.
The LeadCare® testing system, which utilizes anodic stripping voltammetry (ASV) methodology, has been widely used worldwide for cost-effective blood lead level (BLL) screening. However, some concerns have recently been issued regarding inaccurate results obtained using LeadCare®. Hence, we aimed to evaluate the accuracy of BLL measured by LeadCare® II (BLL) by comparison with ICP-MS (BLL) by the Passing-Bablok regression, Deming regression, and Bland-Altman analyses by using 994 venous blood samples. BLL ranged from 3.3 to 162.3 μg/dL, while BLL ranged from 0.8 to 154.8 μg/dL. Although BLL and BLL exhibited a strong and positive correlation, BLL values were generally greater than BLL values, indicative of the overestimation of the LeadCare® analysis. A large positive bias of 19.15 ± 8.26 μg/dL and 29.25 ± 14.04 μg/dL for BLL compared with BLL were recorded in the BLL range of 45.0-64.9 μg/dL and for ≥65.0 μg/dL, respectively. In contrast, a bias of ≤0.3 μg/dL was observed at a BLL of less than 10.0 μg/dL. Blood copper, cadmium, and iron levels did not exhibit an effect on the bias of BLL, indicative of the minimal potential interferences of the metals; these interferences are a cause for concern with the ASV method. In conclusion, LeadCare® analysis is thought to be a good tool for screening purposes at a lower BLL around the reference level of 5 μg/dL in the initial stage; however, conversion or retesting using a laboratory analyzer is recommended at a higher BLL for appropriate clinical evaluation and research.
LeadCare® 检测系统采用阳极溶出伏安法（ASV），已在全球范围内广泛用于具有成本效益的血铅水平（BLL）筛查。然而，最近有一些关于使用 LeadCare® 获得的结果不准确的担忧。因此，我们旨在通过 Passing-Bablok 回归、Deming 回归和 Bland-Altman 分析，使用 994 份静脉血样本，评估 LeadCare® II 测量的 BLL（BLL）与 ICP-MS（BLL）的准确性。BLL 范围为 3.3 至 162.3μg/dL，而 BLL 范围为 0.8 至 154.8μg/dL。尽管 BLL 和 BLL 表现出强烈的正相关，但 BLL 值通常大于 BLL 值，表明 LeadCare® 分析存在高估。在 BLL 范围为 45.0-64.9μg/dL 和≥65.0μg/dL 时，与 BLL 相比，BLL 的偏倚分别为 19.15±8.26μg/dL 和 29.25±14.04μg/dL，为较大的正偏倚。相比之下，在 BLL 小于 10.0μg/dL 时，观察到的偏倚小于 0.3μg/dL。血铜、镉和铁水平对 BLL 的偏倚没有影响，表明金属的潜在干扰最小；这些干扰是 ASV 方法令人关注的原因。总之，LeadCare® 分析被认为是一种在初始阶段参考水平 5μg/dL 左右较低 BLL 时用于筛查的良好工具；然而，对于更高的 BLL，建议使用实验室分析仪进行转换或重新测试，以进行适当的临床评估和研究。
