Magellan Diagnostics, Inc., receives US Food and Drug Administration (FDA) clearance to market the LeadCare Plus Blood Lead Testing System in the US for the quantification of lead levels in blood.
The device neatly fits into even the smallest clinical labs, taking up only 60 square inches (390 sq cm) of desktop space. It relies on single-use consumables and features electronic calibration for quick and easy setup and testing when a suspected patient shows up.
The device can test either capillary or venous whole blood, detecting concentrations of lead down to 1.9 µg/dL. Results are produced within about three minutes and the device can process up to about 20 samples per hour.
Blood lead testing is a critical preventative service for children: the symptoms of lead exposure are non-specific and sub-clinical; therefore a routine blood test is often the only way to identify exposure in a child.
Without early detection, elevated blood lead levels can impair cognition, reduce IQ, and cause attention-deficit disorders. According to the Centers for Disease Control and Prevention (CDC), there are over half a million US children still affected with elevated blood lead levels.
Amy Winslow, president of Magellan Diagnostics, said, "We are pleased that the FDA has cleared the LeadCare Plus System. Our mission is to help expand access to blood lead testing by offering a solution for every setting. With our other products, CLIA-waived LeadCare II for point-of-care testing and LeadCare Ultra for high throughput lab analysis, LeadCare Plus completes this offering by providing a low capital cost system that gives even small labs the opportunity to bring this test in-house."