Tests for lead poisoning may be faulty, US regulators warn

Certain tests to detect lead poisoning could produce faulty results, regulators warn

Federal officials are warning that certain lead tests manufactured by Magellan Diagnostics, which have been commonly used to test those affected by the water crisis in Flint, Michigan, may provide inaccurate results that underestimate lead levels.

The CDC recommends healthcare professionals retest children now aged 6 years if their test was done (using blood from a vein) with any Magellan Diagnostics' LeadCare System test and they received a result of 10mcg/dL.

FDA officials believe the problems with the tests may have started in 2014 and are investigating. Now available data indicate that the lead tests, when performed on blood drawn from a vein, could provide results that are lower than the true level of lead in the blood.

However, Shuren said Magellan was aware of the issue as early as August 2014, when it received complaints from customers about the accuracy of the tests.

The FDA's warning was issued for all four lead testing systems from Magellan Diagnostics including LeadCare, LeadCare II, LeadCare Plus and LeadCare Ultra. The agency believes the tests are accurate, however, when used with blood from a finger or heel stick.

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. It also recommended that women who are pregnant or nursing get retested.

Tests given to 128 Flint residents may have registered falsely low blood lead levels, the Michigan Department of Health and Human Services says. 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.

Though Magellan had identified another inaccuracy issue with an additional product in 2015, that information was not conveyed to the FDA during the 510 (k) process despite repeated interactions, Dr. Shuren said, because the company saw it as a low-risk issue it considered resolved. The agency discovered that the company "significantly underestimated" the amount of risk to the public, and lacked "adequate data and supporting documentation regarding the cause of the problem and effectiveness of mitigation". He added that the agencies are looking into potential causes (such as the type of tubes or chemicals used during processing), and to "confirm there is no problem with the capillary blood test".

Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH), said that most patients won't be affected the issue, as the majority of lead testing is done using capillary blood, and about half of all tests are processed using other unaffected methods, such as graphite furnace atomic absorption spectroscopy (GFAAS). If such results find elevated lead levels, the results are confirmed through a venous blood test. "Lead exposure can affect almost every system in the body".

If you think you or your child needs another lead test, talk with your doctor. Lead poisoning is particularly risky to infants and young children. Whether diseases start at home or overseas, are curable or preventable, chronic or acute, stem from human error or deliberate attack, CDC is committed to respond to America's most pressing health challenges.

Related News:



Most liked

Mazzarri to leave Watford
His predecessor, Slavisa Jokanovic, left Watford soon after guiding the team back into the Premier League for the 2015-16 season. Mazzarri is the eighth different manager to depart since the Pozzo family took control of the club in the summer of 2012.

Ebrahim Raisi, the hardline challenger in Iran
Rouhani has history on his side: no sitting President has failed to win a second term since 1981. So far, two presidential nominees have dropped out of the country's presidential election.

IPL 2017: Don't Think Last Two Overs Cost Us, Says Parthiv Patel
We felt that the wicket was pretty dry and it was holding for the spinners and pacers as well. "MS bhai played outstanding shots". Rising Pune Supergiant beat Mumbai Indians by 20 runs in Qualifier 1 on Tuesday evening at the Wankhede stadium.

Corrine Brown found guilty on fraud and tax evasion charges
Corrine Brown has gone home for the night, after almost 12 hours of deliberation. Brown's sentencing date has yet to be set, WTLV-TV reported .

World leaders reach consensus on B&R development
India's already out , due to included projects for roads and railways that run through disputed territory in rival Pakistan. The event is being attended by leaders from at least 29 countries, including Pakistan.

Cardinals look to play cleaner game in finale vs. Red Sox
And by the time he exited, the Red Sox had reclaimed the lead to allow for what would be the starter's second win of the season. Two more hits and a sacrifice fly later and Rodriguez had given the lead right back to the Cardinals via a three-run inning.

Derby winner Always Dreaming gallops smoothly for Preakness
It likely would have favored the speed horses, just as the public bettors did. "The Derby is a race we always want to win". Classic Empire came out of the Kentucky Derby looking as though he'd been in a prizefight instead of a horse race.

Australia plans major spending plus surplus in 3 years
The federal government has projected a deficit of $29.4 billion for 2017-18, down from its projection previous year . The opposition will support a levy on big five banks, which will raise $6.2 billion over four years for budget fix .

DOJ Ramps Up Investigation of Sun-Times Sale
If no viable partner emerges, Tronc and Wrapports intend to continue pursuing a deal to successfully close the transaction. Under terms of the deal, the Sun-Times reported, Tronc would own and operate the Sun-Times as an independent business.

Meghan Markle attends polo match featuring Prince Harry
Pippa has a "no ring, no bring" policy, but she is said to be making an exception for Meghan , according to the Telegraph . Their attendance at the polo match marked their first ever public outing since confirming their relationship in November.

JPMorgan buys office building in Ireland amid Brexit fears
JP Morgan already employs approximately 500 people at its Dublin headquarters in the north dock. JP Morgan has started preparing for Brexit as it buys new office space in Dublin.

Former AG Yates tells Senate she warned of Flynn vulnerability
Here's what changed when a former Justice Department official testified about the Trump administration and Russian Federation . Flynn was later fired for lying to Vice President Mike Pence about his conversations with the Russia's ambassador to the U.S.

Murray says health key to hopes of prolonging his career
Murray is now in Rome , where he is set to meet local player Fabio Fognini after having a first-round bye previously. Spain's 14-time Grand Slam champion is now a strong favourite to claim his 10th French Open crown next month.

Trump says 'fast decision' possible on new FBI director
McCabe characterized the investigation as "highly significant" and assured senators that Comey's firing would not hinder it. The Watergate scandal accelerated drastically when it was revealed Nixon taped conversations in the White House.

Microsoft says cyberattack should be wake up call for governments
Europol spokesman Jan Op Gen Oorth said it was too early to say who was behind the onslaught and what their motivation was. Security experts tempered the alarm bells by saying that widespread attacks are tough to pull off.