Lead Test By Magellan Diagnostics For Children And Women May Yield Inaccurate Results: FDA

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On Wednesday, May 17, the U.S. Food and Drug Administration and the Centers for Disease Control warned Americans that certain blood tests used to monitor lead levels may have delivered inaccurate results.

The health officials shared that children upto six years, as well as pregnant and nursing women may need to go for a retest to get accurate results for possible lead poisoning.

The FDA and CDC revealed that Magellan Diagnostics manufactured the faulty lead tests that are under scrutiny. These faulty lead tests may have inaccurately diagnosed several cases going back to 2014. The FDA and CDC believe that the original blood tests Magellan Diagnostics conducted may have misjudged the lead amount present in the blood and gave parents false assurance.

Magellan Diagnostics’ Faulty Lead Test

The FDA indicated that all four of Magellan Diagnostic’s lead testing systems — LeadCare II, LeadCare, LeadCare Ultra, and LeadCare Plus — may have provided faulty results by performing tests on vein-drawn blood. The most common method of testing lead levels in the blood is done by pricking heels and fingers instead of veins.

Health officials also suggest that that the diagnosed lead levels may have been lower than the original lead levels in the blood.

“The FDA is concerned that Magellan lead tests that use blood drawn from a vein may provide results that are lower than the actual level of lead in the blood. There is little evidence that Magellan tests using blood from a finger or heel stick are affected,” FDA’s Jeffrey Shuren stated in a press release.

The FDA officials believe that roughly 8 million blood tests may have been conducted using a Magellan-developed testing system since 2014. However, most of the tests were conducted with blood drawn from the capillary and not the vein. Meridian Biosciences acquired Magellan in 2016. The company stated that only 10 percent blood tests are carried out with blood drawn from the veins and accounts for about $1.8 million of Magellan Diagnostic’s revenue.

“Meridian and Magellan take these matters very seriously and will continue to work closely and fully with the F.D.A. and C.D.C. to address the concerns identified with venous samples as quickly as possible,” the statement asserted.

CDC Recommendations For Children And Women

Since there are a large number of cases having inaccurate lead test results, CDC health officials recommend all physicians and healthcare professionals retest all children younger than 72 months.

The health officials assert that retesting should only be done for children whose blood was drawn from the vein during the test, which any Magellan Diagnostics’ LeadCare System conducted, and the results determined concentration in blood of less than 10 micrograms per deciliter.

Apart from children, CDC also advises pregnant and nursing women to undergo another lead test if their blood was drawn from the veins.

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