CDC Issues Health Advisory about Potential for Falsely Low Blood Lead Test Results from LeadCare® Analyzers

PUBLISHED: May 19, 2017
Sources: Centers for Disease Control and Prevention, Food and Drug Administration
Relevant to: Lab, Medical Office/Clinic, Ambulatory Care, Hospital

The Centers for Disease Control and Prevention (CDC) has issued a Health Advisory about the recent U.S. Food and Drug Administration's (FDA's) Safety Communication (see the StayAlert! Notice published on May 17, 2017) warning about the use of Magellan Diagnostics’ LeadCare® analyzers (LeadCare, LeadCare II, LeadCare Ultra and LeadCare Plus) with venous blood samples because they might result in falsely low test results.

Background

The CDC was contacted on April 24, 2017 by the FDA requesting assistance in assessing the potential public health risk of a negative bias associated with Magellan’s lead testing systems. The FDA is now warning that Magellan Diagnostics’ LeadCare® analyzers should no longer be used with venous blood samples due to the potential for falsely low test results.

Not all blood lead tests are affected. Laboratory tests analyzed by inductively coupled plasma-mass spectrometry (ICP-MS) or graphite furnace atomic spectrometry (GFAAS) (also known as electrothermal atomic absorption spectrometry [ETAAS]) are not expected to have resulted in falsely low results. This safety alert applies to venous blood lead tests conducted using Magellan Diagnostics’ LeadCare® analyzers whether the patient is a child or an adult.

At this time, the safety alert does not apply to capillary blood lead test results collected by fingerstick or heelstick using Magellan Diagnostics’ LeadCare® analyzers. Children are particularly vulnerable to lead exposure due to the effect on their developing brains and organ systems. CDC is working with public health officials throughout the United States to determine where the analyzers were used and which blood lead test results might be affected.

Recommendations:

CDC recommends that healthcare providers re-test patients who:

1) are younger than 6 years (72 months) of age at the time of the alert (May 17, 2017) and
2) had a venous blood lead test result of less than 10 micrograms per deciliter (µg/dL) analyzed using a Magellan Diagnostics’ LeadCare® analyzer at an onsite (e.g., healthcare facility) or at an offsite laboratory.

CDC also recommends that healthcare providers re-test currently pregnant or lactating women who had a venous blood lead test performed using a Magellan Diagnostics’ LeadCare® analyzer.

CDC recommends parents discuss re-testing with their healthcare provider or health department to determine if their child’s blood should be re-tested.

If re-testing indicates blood lead levels in excess of the CDC reference level (www.cdc.gov/nceh/lead/acclpp/blood_lead_levels.htm), or the state or local action level, the healthcare provider or public health official should refer to CDC and/or local guidelines for appropriate follow-up action (www.cdc.gov/nceh/lead/acclpp/actions_blls.html).

Re-tests are not recommended if the provider is certain that analyzers other than those described by this Health Advisory were used to analyze the venous blood samples.

For future blood lead testing, healthcare providers and public health officials should:

  • Send venous samples to Clinical Laboratory Improvement Amendments (CLIA)-compliant laboratories using inductively coupled plasma mass spectrometry (ICP-MS) or graphite furnace atomic absorption spectrometry (GFAAS) (also known as electrothermal atomic absorption spectrometry [ETAAS]) instruments.
  • Send capillary samples to CLIA-compliant laboratories using any CLIA compliant analyzer including ICP-MS, GFAAS, or LeadCare® analyzers.

The CDC’s Health Alert contains a flow diagram to aid in determining the need for re-testing. Follow the link below to access the CDC’s Health Advisory.

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