Evaluation of LeadCare Ultra® as an initial screen for elevated blood lead levels

• Published in: Clinical biochemistry 2019-04, Vol.66, p.95-99
• Main Authors: Johnson, Lisa M., Lynch, Maureen, Johnson, Cindy, Karger, Amy B.
• Format: Article
• Language: English
• Subjects: Children; ICP-MS; Lead; LeadCare; Screen
• ISSN: 0009-9120; 1873-2933
• DOI: 10.1016/j.clinbiochem.2019.02.010

The LeadCare Ultra® (LCU) was compared to inductively coupled plasma mass spectrometry ICP-MS for use as a screening test for elevated blood lead levels (BLLs) in capillary samples from children. During the validation, method comparisons between LCU and ICP-MS were analyzed to determine the bias above, near, and below the BLL cut-off of 5 μg/dL. Additionally, capillary samples that screened positive by LCU (above the 5 μg/dL cut-off) were compared to venous samples analyzed by ICP-MS for confirmatory testing. LCU had a positive bias (1.7 μg/dL) below the cut-off of BLL 10 μg/dL compared to ICP-MS. Of the 59 capillary samples that screened positive by LCU between May of 2017 to April of 2018, 19 were confirmed positive by ICP-MS, 30 were confirmed negative by ICP-MS, and 10 did not have a confirmed result. The LCU assay is an acceptable screen for capillary samples with the BLL cut-off of 5 μg/dL. •LeadCare Ultra has a low bias near the blood lead level cut-off of 5 μg/dL when compared to ICP-MS•However, the LeadCare Ultra has a high positive bias (1.7 μg/dL) for blood lead levels less than the cut-off of 5 μg/dL.•The LeadCare Ultra is prone to false positive results rather than false negative results near the cut-off.