Until further notice, the Ohio Department of Health (ODH) does not recommend the use of Magellan Diagnostics’ LeadCare® analyzers (LeadCare, LeadCare II, LeadCare Ultra, and LeadCare Plus) to analyze any venous blood samples for the concentration of lead in human blood, regardless of the patient’s age or health condition. Laboratories should continue using LeadCare® analyzers on capillary blood samples collected by fingerstick or heelstick.
The U.S. Food and Drug Administration (FDA) has issued a safety communication warning about the use of these analyzers with venous blood samples because they might result in falsely low test results.
Also, please note that ODH does not accept venous blood lead test results analyzed on LeadCare analyzers as confirmatory blood lead tests results (OAC. 3701-30-03, paragraph C, Blood Lead Screening Tests). Venous blood samples must be analyzed by an Ohio-approved laboratory using other analytical devices to confirm a child’s blood lead level at or above 5 micrograms per deciliter. All venous samples analyzed on LeadCare devices are treated as if they are capillary samples, which require confirmation testing by a different analytical device.
- Are younger than 6 years (72 months) of age at the time of the FDA alert (May 17, 2017); and
- Had a venous blood lead test result of less than 10 micrograms per deciliter (µg/dL) analyzed using a LeadCare® analyzer.
The CDC also recommends that physicians and other health care professionals re-test currently pregnant or lactating women who had a venous blood lead test performed using a LeadCare® analyzer.