Rapid Lead Screening Test - Questions and Answers

9/14/06

FDA Expands Availability of LeadCare II Blood Lead Test System
On September 6, 2006, FDA expanded the availability of the LeadCare II Blood Lead Test System to more than 115,000 doctors’ offices, clinics and other sites nationwide. The LeadCare II Blood Lead Test System, manufactured by ESA Biosciences, is used to screen children and adults for harmful levels of lead.

Lead poisoning in children typically results from drinking water from corroding plumbing, and inhaling or ingesting dust from deteriorating lead-based paint. Symptoms of lead poisoning include headaches, stomach cramps, fatigue, memory loss, high blood pressure, and seizures, though there may be no symptoms at lower levels of lead poisoning.  

According to CDC, more than 300,000 children under age 6 each year have blood levels that exceed the threshold used to indicate lead poisoning. Lead poisoning has been linked to learning disabilities and developmental delays. The following websites contain more information about lead poisoning:

Centers for Disease Control and Prevention (CDC) Lead Poisoning Prevention Program

U.S. Environmental Protection Agency (EPA) Lead Awareness Program

U.S. Department of Housing and Urban Development (HUD) Healthy Home and Lead Hazard Control

What does the LeadCare II Blood Lead Test do?
The test measures lead in blood samples taken from a patient in a doctor’s office or clinic, and gives results in as little as 3 minutes. If the test indicates elevated lead levels, a second sample can be obtained before the patient leaves for further testing. Furthermore, if the result indicates high levels of lead, doctors and patients can begin discussing treatment options immediately.

Is this a new test?
This lead screening test was already cleared by FDA for use by certain hospitals, private laboratories and large physician practices that are capable of performing moderate and high-complexity testing. There are around 35,000 such facilities in the U.S. This meant other doctors had to send their samples to these facilities and wait for results. Doctors have expressed concern that many patients who might be affected by lead poisoning did not return for follow-up testing.

FDA has broadened access to this test by granting a Clinical Laboratory Improvement Amendments (CLIA) waiver, which gives manufacturers approval to market a test to doctors’ offices, clinics and other health care sites in addition to hospital laboratories. An already-approved or cleared test can qualify for a CLIA waiver if the manufacturer demonstrates that the test is so simple and so accurate that health care professionals without conventional laboratory training can use it in minimally-regulated labs.

What are the benefits of this test?
Making the LeadCare II blood test available more widely makes testing more convenient for both patients and doctors. Patients learn their test results right away, and follow-up testing, if needed, can be done on the spot. Doctors do not have to try and locate patients who may be hard to reach to give them their test results or to discuss treatment options with patients with elevated blood lead levels.

FDA’s expansion of this test bolsters ongoing efforts to reach populations at greatest risk for lead poisoning, in particular, young children with inadequate access to medical care. Health care professionals can now screen many more people for exposure to lead, particularly inner city residents and minority groups who may live in areas with deteriorating lead-based paint and corroded plumbing.

Is this test effective in screening patients for lead poisoning?
This test is very effective for screening. As with blood lead tests performed in laboratories, initial test results showing lead levels higher than 10 micrograms per deciliter (10µg/dL) need to be confirmed with additional laboratory blood tests.

Where will the test be available?
This CLIA waiver expands availability of the LeadCare II blood test to more than 115,000 doctors’ offices, clinics and other sites nationwide.  

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