Assessment of LeadCare (R) II analysis for testing of a wide range of blood lead levels in comparison with ICP-MS analysis

The LeadCare (R) 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 (R). Hence, we aimed to evaluate the accuracy of BLL measured by LeadCare (R) II (BLLLC) by comparison with ICP-MS (BLLIM) by the Passing-Bablok regression, Deming regression, and Bland-Altman analyses by using 994 venous blood samples. BLLLC ranged from 3.3 to 162.3 mu g/dL, while BLLIM ranged from 0.8 to 154.8 mu g/dL. Although BLLLC and BLLIM exhibited a strong and positive correlation, BLLLC values were generally greater than BLLIM values, indicative of the overestimation of the LeadCare (R) analysis. A large positive bias of 19.15 +/- 8.26 mg/dL and 29.25 +/- 14.04 mu g/dL for BLLLC compared with BLLIM were recorded in the BLLLC range of 45.0-64.9 mu g/dL and for >= 65.0 mu g/dL, respectively. In contrast, a bias of <= 0.3 mu g/dL was observed at a BLLLC of less than 10.0 mu g/dL. Blood copper, cadmium, and iron levels did not exhibit an effect on the bias of BLLLC, indicative of the minimal potential interferences of the metals; these interferences are a cause for concern with the ASV method. In conclusion, LeadCare (R) analysis is thought to be a good tool for screening purposes at a lower BLL around the reference level of 5 mg/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. (C) 2021 Elsevier Ltd. All rights reserved.