Clinical Trial Results

PUBLICATION:

 

A double blind clinical trial was conducted at Emory University Children’s Hospital in conjunction with the Georgia Department of Human Resources, Atlanta, GA and University of Massachusetts, Boston.  More than 500 children between the ages of 6 months to 6 years were tested.  The research results, soon to be published in The Journal of Clinical Toxicology, show that oral fluid is in all cases more reliable than any saliva test and in fact is as reliable as a venous blood test, because blood plasma is being collected in the oral fluid.

lead-testing-oral-fluid

 

 

Oral Fluid Testing Laboratory, LLC. PATENT

oft-labs-patent

On November 9, 2010, the U.S. Patent Office issued OFT Labs Patent #7829340.

 

This patent clearly indicates that the results of the oral fluid testing procedures are as accurate as venous blood samples.  Using OFT’s patented collection and testing procedures, the results comparing the non-invasive painless test versus an invasive painful blood test were 99.19% accurate.  Lead is measured in Ug/Dl,

or micro-grams per deciliter [1 µg/dL = 5 ppm (parts per million)].  Simply put, the instrument is well within the capabilities of being able to produce an accuracy well over 1,000 times the current accuracy used, even accounting for sample dilution and instrument error.

 

 

PUBLICATION in the Journal of Analytical Toxicology.

Journal of Analytical Toxicology Advance Access published September 13, 2016

Journal of Analytical Toxicology, 2016

Evaluating Oral Fluid as a Screening Tool for Lead Poisoning Article

Sher Lynn Gardner1, Robert J. Geller1,2,*, Robyn Hannigan3, Yu Sun4, and Anil Mangla5

1. Emory University School of Medicine, Pediatrics, Atlanta, GA, USA,

2. Georgia Poison Center, Atlanta, GA, USA,

3. University of Massachusetts School of the Environment, Boston, MA, USA,

4. Georgia Department of Public Health, Epidemiology, Atlanta, GA, USA, and 5San Antonio Department of Health, San Antonio, TX, USA

Abstract:

Context: Screening for lead poisoning is necessary in young children, but obtaining the needed blood sample is unpleasant and sometimes very difficult. Use of an alternative screening method that is less unpleasant and less difficult would likely help to increase the percent of children receiving screening.

Objectives: To evaluate the correlation of oral fluid and blood lead in a clinical setting, and to ascer- tain the acceptability and feasibility of obtaining oral fluid from a young child in the clinical setting. Methods: Oral fluid samples were collected from a convenience sample of 431 children aged 6  months to 5 years already due to receive a blood lead test in a primary care clinic. Blood lead results obtained at the same time were available for 407 children. The results of the two  tests  were compared with the blood lead test considered to be the “gold standard”. Data analysis used Pearson correlations, scatter plots, linear regression, ANOVA and Bland–Altman analysis.

Results: Around 431 patients had oral fluid samples available for analysis, and 407 patients had blood samples available. Patients who had both blood concentrations <5 µg/dL and oral fluid values below the screening cutoff value were 223, while eight had both blood concentrations ≥ 5

µg/dL and oral fluid values above the screening threshold. Elevated oral fluid but blood lead values less than the value recommended for further intervention occurred in 176; no patients had ele- vated blood lead values with below-intervention oral fluid values. The negative predictive value of an oral fluid lead below the screening cutoff value was 100%.

Conclusions: The use of oral fluid to screen for elevated body burdens of lead instead of the usual blood lead sample is feasible with a negative predictive value of 100%, while eliminating the need for blood for lead screening in more than half of these children. 

 

For information about Clinical Trial results, please click here to view.

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