Potential for Falsely Low Blood Lead Test Results from LeadCare® Analyzers

The U.S. Food and Drug Administration (FDA) has issued a safety communication 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. FDA is now advising that Magellan Diagnostics’ LeadCare® analyzers should no longer be used with venous blood samples. The safety alert does not apply to capillary blood lead test results collected by fingerstick or heelstick. You can receive more information on the FDA Safety Communication Warning listed below.

FDA safety communication warning, May 17, 2017. Available at:

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm558733.htm 

The purpose of this CDC Health Advisory is to notify state and local health departments, healthcare providers, and laboratories about CDC’s re-testing guidance in light of the safety alert. 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. These are CDC recommendations regarding this safety alert. 

CDC recommends that healthcare providers re-test patients who:

  • CDC recommends that healthcare providers re-test patients who are younger than 6 years (72 months) of age at the time of the alert (May 17, 2017)
  • CDC recommends that healthcare providers re-test patients who 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. 

CDC recommends 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.

Lead Poisoning Prevention - Children

Lead can damage nearly every system in the human body, and has harmful effects on both adults and children. Lead is a serious environmental public health threat to children in Louisiana and in the United States.

The Louisiana Healthy Homes and Lead Poisoning Prevention Program (LHHCLPPP) provides program funding, public and professional education, public health lead investigations, case management, data collection and analysis. The program addresses the needs of lead-poisoned children from birth through 72 months of age. The program assists family members, medical care providers and other community members to reduce and prevent lead poisoning.  LHHCLPPP recognizes that children under the age of 36 months are at greatest risk for lead poisoning.

Services include:

  • Monitoring of blood lead levels in children six years of age and under;
  • Identification of children with elevated blood lead levels;
  • Care coordination for these children with elevated blood lead levels;
  • Environmental inspection for the children with elevated blood lead levels; and
  • Community and professional education on childhood lead poisoning.

This program is funded by the Centers for Disease Control and Prevention (CDC) for childhood lead poisoning-prevention efforts in Louisiana. LHHCLPPP receives all blood lead laboratory reports on Louisiana resident children and contributes to the CDC national database on lead poisoning. The program also promotes the CDC’s national lead poisoning prevention guidelines.

Questions can be directed to the Louisiana Childhood Lead Poisoning Prevention Program, at (504)568-8254.

LHHCLPPP provides specific guidance in the form Management for Follow-Up Blood Level.

Get your child tested

The Louisiana Healthy Homes and Lead Poisoning Prevention Program (LHHCLPPP) provides program funding for public health lead investigations based upon the elevated blood lead levels of children by a venous test result greater than 10 ug/dL.

Physician Flyer was created by the LHHCLPPP for Health care professionals as a guidance on routine blood lead screening for children.

There is no “safe” level of lead in the blood – any confirmed level is an indication that the child has been exposed. Blood tests are usually recommended for:

  • Children at ages 1 and 2 years of age;
  • Children between 3 and 6 years of age if not previously tested.
  • Children or other family members who may have been exposed to high levels of lead.

Get your home tested for lead

LHHCLPPP provides guidance on Assessing the Risk of Lead Exposure based on CDC's recommendations

Parent Flyer was developed by LHHCLPPP as a reference guide for routine care of children as well as home check list for lead exposure risks.

Recommendations on contractors

Please click here for the updated list of certified lead contractors as listed on the Louisiana State Licensing Board for Contractors.

Louisiana State Licensing Board for Contractors (LSLBC)

According to Louisiana Department of Environmental Quality (LDEQ) regulations, Lead-based Paint abatement contractors must be licensed by the Louisiana State Licensing Board for Contractors. For information to obtain a license to abate Lead-based Paint, you may contact the LSLBC by phone, 225-765-2301 or view their web site for additional information at:    http://www.LSLBC.louisiana.gov/

 

Lead-Based Paint Hazard Control in Privately Owned Housing - HUD

In fall of 2016, the Louisiana Department of Health’s Louisiana Healthy Homes and Lead Poisoning Prevention Program (LHHCLPP) was awarded more than $1.2 million from the U.S. Department of Housing and Urban Development (HUD) to perform lead-hazard control work on properties housing one or more children under six years of age. The grant is funded for three years with a Healthy Homes Supplemental funds in the amount of $150,000 to be used during this three year period. The grant enables LHHCLPPP to conduct lead hazard control and healthy homes work in 17 Louisiana parishes (click here to view the map). Specifically, the funds are used for the identification of lead hazards in units occupied by children who have been lead poisoned or are at risk of becoming lead poisoned; the remediation of the lead hazards through appropriate control or abatement procedures; and, ancillary activities such as training, outreach, and casework.

Get the Facts