June 12, 2009
Until now, the only accurate way to test for lead poisoning was through invasive needle or finger sticks. Recently, a safer, less-invasive method with no trauma to the child has been validated by laboratory analysis. The trial found that oral fluid swabs can be used successfully to measure lead levels in children.
The clinical trial was designed and correlated by Dr. Anil T. Mangla, Chief Lead Epidemiologist for the Department of Human Resources, Division of Public Health of Atlanta. Dr. Mangla is also Adjunct Professor at the University of Georgia, and is a Community Assistant Professor at Mercer University, School of Medicine.
“The success of this study is a milestone for lead testing on a universal scale,” said Dr. Mangla. “Children living in inner cities are at higher risk of being exposed to lead due to older homes. Also, unlike blood samples which need to be refrigerated, oral fluid swabs do not need refrigerated storage. This is a major benefit when marketed to third world countries.”
Another key breakthrough for this test is its “green” factor. There is no medical waste with oral fluid testing which is a major step in eliminating medical waste and the cost associated with it.
This test is faster, less invasive and is a far cry from having children endure a painful blood collection. During this study some of the oral fluid samples were collected from children as they slept in their mothers’ arms, encouraging parents to screen their children for lead poisoning.
This was the first clinical trial of its kind, and was completed at Emory University Hospital, Children’s Healthcare of Atlanta, and at Hughes Spalding Atlanta, Georgia. This trial was administered by Lynn Gardner MD, Assistant Professor of Pediatrics Emory University and analyzed by Robyn Hannigan PhD, Co-Inventor of GeoMed Analytical located at the University of Massachusetts, Boston. All doctors and scientists involved worked tirelessly
to oversee this study from its beginning to its successful conclusion.
No government or corporate funds were used to complete this study. The inventors of this test used personal funds and a strong desire to bring a green, painless, accurate screening tool to the world.
More about the clinical trial:
There were approximately 240,000 children with lead poisoning the U.S. in 2008. Lead poisoned children are at higher risk for having neurodevelopmental deficits and various behavior problems.
Current screening practices are complicated by the need to obtain blood from a young child. Oral fluid can be used in vitro to measure lead, but has not been tested in a clinical setting. This study compares oral fluid and blood lead levels in a clinical setting.
Oral fluid appears to be a reliable medium to use when screening children for lead exposure. Oral fluid lead levels > or = 5 mcg/dL should be confirmed by a venous blood sample. The convenience of lead screening by measurement of oral fluid should improve our screening success by reducing parental refusal and eliminating inability to obtain an adequate blood sample.
Oral fluid samples were collected on 500 children aged 6 months to 5 years in a primary care clinic. Children due to have blood lead levels drawn were eligible. Blood lead levels were measured by standard methodology and oral fluid lead levels were measured using an ICP-MS (DRC II, PerkinElmerSciex). Oral fluid samples from 50 children were gathered twice to provide internal controls, but were counted once.
Data analysis used Pearson correlations, scatter plots and linear regression. The mean absolute difference between the sample groups was determined to test the hypothesis that group means are equal (-ƒÑ=0.05).
500 patients agreed to enroll. 474 patients had both blood and oral fluid samples available for analysis; 25 did not have blood available. 455 patients had both oral fluid and blood levels <5 mcg/dL, and 19 had both oral fluid and blood levels > or = 5 mcg/dL. All oral fluid levels <5 mcg/dL correlated with a venous blood level <5 mcg/dL, p-<0.05. Internal controls suggested no variations, p<0.05 Authors: Gardner L, MD, Geller R, MD, Sun Y, PhD, Mangla A, PhD, Hannigan R, PhD. Abstract Title: Accuracy of Lead Level Measurement Using Oral Fluids