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Guidelines for measuring lead in blood using point of care instruments

Filetype[PDF-471.46 KB]


  • English
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    • Corporate Authors:
      United States. Advisory Committee on Childhood Lead Poisoning Prevention.
    • Description:
      This document was solely produced by the Advisory Committee for Childhood Lead Poisoning Prevention and adopted with one abstention on July 25, 2013. The posting of this document to our website in no way authorizes approval or adoption of the guidelines by CDC.

      Clinical laboratories primarily assess lead exposure using whole blood lead measurements. Although a number of human tissues and body fluids also reflect lead exposure, the concentration of lead in whole blood has gained wide acceptance as the most useful tool for screening and diagnostic testing, primarily because of contact between the blood and the entire body, and the equilibrium between lead in blood and lead in organs and tissues. In very young children, lead in whole blood is an indicator mainly of recent exposure although there can be input to total blood lead from past accumulation in the body. In adults and particularly lead workers, the past accumulation can be a more prominent contributor to total blood lead.

      Guidance has been previously published for the clinical laboratory testing community involved in the collection of blood for the measurement of lead by high complexity laboratory methods. The present document provides guidelines for point of care blood lead testing using methods waived from the provisions of the Clinical Laboratory Improvement Amendments of 1988 by the Food and Drug Administration based on its low complexity. The document also briefly describes specific guidance for the use of the LeadCare® II instrument as this is the only POC device for blood lead testing currently commercially available for use in the U.S. These guidelines are consistent with “Low Level Lead Harms Children: A Renewed Call for Primary Prevention” approved by the Advisory Committee on Childhood Lead Poisoning Prevention in January 2012. In May 2012, the Centers for Disease Control and Prevention concurred with the recommendations in the January 2012 document.

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    • Genre:
      Guidance
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