Clinical Chemistry
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Clinical Chemistry 53: 994-995, 2007; 10.1373/clinchem.2006.082404
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(Clinical Chemistry. 2007;53:994-995.)
© 2007 American Association for Clinical Chemistry, Inc.

Letters to the Editor

Blood Lead Misclassification Due to Defective LeadCare® Blood Lead Testing Equipment

Robert M. Bossarte1, Mary Jean Brown2,a and Robert L. Jones3

1 Department of Community Medicine, School of Medicine, West Virginia University, Morgantown, WV
2 Lead Poisoning Prevention Branch, Division of Emergency and, Environmental Health Services, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA
3 Inorganic Toxicology and, Radionuclide Laboratories, Division of Laboratory Services, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA

aAddress correspondence to this author at: Lead Poisoning Prevention Branch, Centers for Disease Control and Prevention, 4770 Buford Highway, NE (MS-F40), Atlanta, GA 30341. Fax 770-488-3635; e-mail mjb5@cdc.gov.

The first 20% of the full text of this article appears below.


To the Editor:

In May, 2005, a partial recall of LeadCare® portable blood lead testing kits was initiated after proficiency testing revealed a negative error (mean, –25%; 95% CI, –15% to –35%) in blood lead concentrations (often called blood lead level in the US) analyzed with this device (1)(2). This bias exceeded previously recommended 95% error thresholds established with graphite furnace atomic absorption spectroscopy (3). The recall included 8 lots of defective sensors containing enough material for an estimated 500 000 patient tests distributed between September 2003 and May 2005.

The LeadCare device uses an anodic stripping voltammetry method to measure lead. Capillary sampling by fingerstick is the most common method of specimen collection. Assessments of the portable units by testing of venous samples from occupationally exposed workers have demonstrated that measurements obtained with these units show an insignificant positive error that decreases as blood lead concentrations increase (4).

A blood lead concentration ≥10 µg/dL (100 µg/L) . . . [Full Text of this Article]






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Copyright © 2007 by the American Association for Clinical Chemistry.