Rapid Lead Screening Test Now Available at More Facilities
MedSun: Newsletter #9, November 2006

The Centers for Disease Control and Prevention (CDC) has found that each year more than 300,000 children under the age of 6 have blood levels that exceed 10 micrograms per deciliter, the threshold used to indicate lead poisoning. The American Academy of Pediatrics (AAP) estimates that one out of four homes with children under age 6 has lead contamination. The CDC and AAP recommend screening children who live in high-risk homes at ages 1 year and 2 years.

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. Lead poisoning in children has been linked to learning disabilities and developmental delays. A test is now available that can provide immediate results on lead levels in children and adults at thousands of places nationwide, including health clinics, mobile health care units, and doctors’ offices. Broader availability of and easier access to this test mean lead exposure can be detected and treated earlier, before the damaging effects of lead poisoning occur. The LeadCare® II Blood Lead Test System measures lead in blood samples using a finger stick or taking a blood sample from a person’s vein, and gives results in as little as 3 minutes. The rapid result means a second sample for further testing can be obtained quickly, if needed, thus reducing the need for a followup visit.

The U.S. Department of Health and Human Services is allowing use of the LeadCare® II Blood Lead Test System, made by ESA Biosciences of Chelmsford, Massachusetts, at more than 115,000 certified point-of-care settings because the company proved to the U.S. Food and Drug Administration (FDA) that the test is simple and accurate, and that it poses very little risk of harm to a patient. The test was previously only available for use in certain laboratories, and patients often times had to wait several days or more to receive their results. Doctors have said that it is sometimes difficult to reach patients to give them their results or to discuss treatment options when such patients have elevated blood lead levels.

Rapid Lead Screening Test Q&A
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 an elevated lead level, a second sample can be obtained for further testing before the patient leaves the facility. Furthermore, if the result indicates high levels of lead, doctors and patients can begin discussing treatment options immediately.

Is this a new test?
FDA had already cleared this lead screening test for use by certain hospitals, private laboratories, and large physician practices capable of performing moderate and high-complexity testing. There are approximately 35,000 such facilities in the United States. This meant that 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 followup 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 laboratories.

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 followup testing, if needed, can be done on the spot. Doctors do not have to locate hard-to-reach patients to give them their test results or to discuss treatment options with them if they have elevated blood lead levels. FDA’s expansion of this test bolsters ongoing efforts to reach populations at greatest risk for lead poisoning, particularly young children with inadequate access to medical care. Health care professionals can now screen many more people for exposure to lead, including 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 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.

Additional Information:

Office of In Vitro Diagnostic Device Evaluation and Safety Web site
http://www.fda.gov/cdrh/oivd/


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