Health care providers play an important role in identifying children at risk for lead poisoning. Children who are at high risk for lead exposure should be screened at 12 and 24 months, per Virginia policy. Pregnant people should be educated about sources of lead, and they should be screened if they are at an increased risk for lead exposure. VDH is committed to supporting health care providers prevent childhood lead poisoning across the Commonwealth.
Important Updates
Risk of False Positive Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems
Date Issued: April 24, 2025
The U.S. Food and Drug Administration (FDA) is alerting health care providers and laboratory staff of reports that falsely elevated (false positive) results have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems. These tests may overestimate blood lead levels and give inaccurate results when processing capillary blood samples collected in these ASP Global’s RAM Scientific SAFE-T-FILL tubes. The root cause of these false results is not yet known. The FDA is recommending that ASP Global RAM Scientific SAFE-T-FILL tubes not be used with the LeadCare Testing Systems while this issue is being investigated.
Recommendations for Health Care Providers and Facilities, Laboratory Staff, and Patients and Caregivers
- Avoid using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.
- The capillary collection devices that are provided with the LeadCare Test Systems as well as other third-party capillary blood collection tubes, as described in the instructions for use of LeadCare Testing Systems, can still be used.
- If no alternate capillary blood collection devices are available other than the ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes, interpret results with caution and consider retesting with a different method or specimen type.
- Follow CDC’s recommendations for confirmatory venous blood testing based on blood lead levels observed in capillary blood lead tests (https://www.cdc.gov/lead-prevention/testing/index.html).
Reporting Problems with Your Device
Health professionals and patients are encouraged to report adverse events or side effects related to the use of ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes, Magellan Diagnostics LeadCare Testing Systems, or other devices to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
- You can submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel and clinical laboratory staff employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
For more information, visit the FDA Safety Communication.
Reference: Food and Drug Administration
Policies
Blood Lead Testing Criteria:
Children in any of the following risk categories should have their blood tested at 12 and 24 months:
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- The child is eligible for or receiving benefits from Medicaid or the Special Supplemental Nutrition Program for Women, Infants and Children (WIC);
- The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1960;
- The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1978 that has (i) peeling or chipping paint or (ii) recent (within the last six months) ongoing or planned renovations;
- The child is living in or regularly visiting a house, apartment, dwelling, or other structure in which one or more persons have blood lead testing yielding evidence of lead exposure;
- The child is living with an adult whose job, hobby, or other activity involves exposure to lead;
- The child is living near an active lead smelter, battery recycling plant, or other industry likely to release lead;
- The child's parent, guardian, or other person standing in loco parentis requests the child's blood be tested due to any suspected exposure; or
- The child is a recent refugee or immigrant or is adopted from outside of the United States.
A child up to 72 months in those categories who hasn't previously been tested (or who has experienced a change that has resulted in an increased risk of exposure to lead), or the sibling of a child who has an elevated blood lead level should also be tested.
Virginia Blood Lead Testing Reporting Guidelines:
On October 20, 2016, the Virginia Department of Health modified its disease reporting requirements:
“Lead, reportable levels” means any detectable blood lead level in children 15 years of age and younger and levels greater than or equal to 5 μg/dL in persons older than 15 years of age.
There are two primary ways to report a blood lead level to the Department of Health:
- Visit Virginia’s Confidential Morbidity Report Portal
- Fax the report to 804-864-8102
Case Management and Follow-Up:
Health care providers and Local Health Department staff should please refer to the Virginia Blood Lead Testing and Case Management Guidelines for recommended case management and follow-up actions.
Supplemental Information
Quick Links
Continuing Education:
CME Module with Medical Society of Virginia - NEW Oct. 2025
Pediatric Environmental Health Specialty Unit (PEHSU)
Professional Resources:
American Academy of Pediatrics
Pediatric Environmental Health Specialty Unit (PEHSU)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Guidance for Special Populations
Pregnant and Lactating People
Lead exposure during pregnancy has been associated with adverse outcomes for both maternal and fetal health. It can cause:
- Increased risk of stillbirth and miscarriage
- Increased risk of the baby being born preterm
- Increased risk of the baby having a low birthweight
- Damage to the baby’s brain, kidneys, and nervous system
- Future developmental and learning problems in the baby
Pregnant individuals who are at increased risk for lead exposure should be screened for lead.
Pregnant individuals are at an increased risk of being exposed to lead if they:
- Live in a home built before 1978.
- Are a recent immigrant or refugee.
- Use imported pottery or ceramics to prepare and store food.
- Have old plumbing and pipes in their home.
- Live with someone who has a job or hobby that may expose them to lead, such as welding, metalwork, building renovation, stained glass, casting, or soldering.
- Developed pica during their pregnancy.
- Use traditional folk remedies or cosmetics.
Pregnant people should follow these simple steps to protect themselves and their baby from the harmful effects of lead:
- Wet-wipe and wet-mop around window sills and home entrances.
- Wash their hands hands often.
- Remove their shoes before entering their home.
- If a family member has a job or hobby that exposes them to lead, ask them to take off their shoes before coming inside and change their clothes immediately after coming home.
- Avoid remodeling their home, sanding paint, or removing paint with a heat gun while pregnant.
Breastfeeding and Lead Exposure
Pregnant and breastfeeding people that have been exposed to lead can pass the lead on to their fetus or infant through blood and breast milk. This can have long-term effects on the neurodevelopment of their child.
Please use the resources linked below for guidance on medical management of an elevated blood lead level during lactation.
Refugee and Newcomers
Refugees and newcomers to the United States are at high risk of lead exposure. Lead hazards are common in countries where many refugees and asylum seekers currently originate. These exposures can be environmental or occupational, or household and/or personal items.
Environmental exposures include:
- Leaded gasoline
- Lead-based paint
- Burning waste that contains lead
Occupational exposures include working in:
- Mines
- Smelting
- Battery recycling facilities
- Ammunition manufacturing
Household and personal item exposures include:
- Lead-glazed pottery
- Cookware and dining utensils
- Spices
- Cosmetics (such as kajal or kohl)
- Traditional medicines and remedies (such as Ba-baw-san, Greta, Paylooah)
Please visit our Information for Parents page or the CDC Immigrant, Refugee, and Migrant Health page for more information on spices and cosmetics known to contain lead.
Exposure After Entering the United States & Federal Screening Guidelines
Refugees and asylum seekers in the United States are also at risk for lead exposure after entering the United States. Members of this population may be placed into older homes that are more likely to contain lead hazards, including:
- Lead-based paint.
- Lead in the soil.
- Lead from old plumbing and water fixtures.
Because of their risk of exposure to lead both before and after entering the United States, it is critical that refugees and asylum seekers receive initial and follow up blood lead screens.
When completing blood lead screens for refugees or asylum seekers new to the United States, it is important to:
- Collect complete and accurate personal and contact information
- Establish a standardizable follow up plan
Without these two components, follow-up blood lead screening cannot be completed in compliance with federal guidelines for refugees and newcomers. Chronic or acute lead exposure after entering the United States cannot be adequately assessed without a follow-up blood lead test.
See the table below for CDC’s recommended screening measures for children and pregnant women after arrival in the United States.
| Recommended Screening Measure | Population |
|---|---|
| Initial lead exposure screening with blood test |
|
| Follow-up testing with blood test, 3-6 months after initial testing |
|
| *All newly arrived pregnant or breastfeeding women should be prescribed a prenatal or multivitamin with adequate iron and calcium. Referral to a healthcare provider with expertise in high-risk lead exposure treatment and management may be indicated for EBLLs. | |
Reference: CDC Lead Screening Guidelines: Domestic Guidelines
More Information:
- CDC Blood Lead Screening Guidelines in Refugee populations
- VDH Newcomer Health Program
- Health education in languages other than English: