
A deep dive into Qbtech's diagnostic ADHD test
A discussion based on an FDA-cleared objective ADHD diagnostic test developed by Qbtech.
In a previous interview with Contemporary Pediatrics, Perry Roy, MD, of Carolina Attention Specialists, Charlotte, North Carolina,
"Currently, most methodologies for diagnosing ADHD is based on history. This [tool] is not replacing a good, accurate history. Other tools that have commonly been used and are certainly used are rating scales, which are quite subjective," said Roy.1
According to Qbtech, the ADHD QbTest is FDA-cleared to aid in diagnosis and treatment evaluation for individuals aged 6 to 60 years. Measuring the core ADHD symptoms of ADHD (activity, attention, and impulsivity), the QbTest takes approximately 15 to 20 minutes to complete, with results delivered in a visual report (Pictured right. Click to enlarge).2
These results compare the patient's results to others in their respective age range and gender without ADHD.2
"To me, I think it adds confidence to the diagnosis," said Roy. "This test can also help us manage the medications, let us know we're on the right track with the medications, [and] help us dose-optimize the medication."
Roy added the general provider can learn how to use and incorporate the test for a diagnosis, or confirm to the provider the need to refer out.
When the test was cleared by the FDA in 2014, the federal agency in a 510(k) summary of safety letter stated, "QbTest results should be interpreted only by qualified professionals."3,4
The QbTest's intended use to support the evaluation of treatment interventions of ADHD was based on 7 published clinical studies and a registry study that was designed to compare QbTest with clinically validated Rating Scales (RS) in the evaluation of treatment interventions.4
View more images of QbTest below (click to enlarge).
References:
1. Fitch, J. Incorporating objective testing to add value to an ADHD diagnosis. Contemporary Pediatrics. April 25, 2024. Accessed April 29, 2024. https://www.contemporarypediatrics.com/view/incorporating-objective-testing-add-value-adhd-diagnosis
2. Qbtech fact sheet from Qbtech. Qbtech. PDF.
3. FDA clears both QbTest and QbCheck. Qbtech. April 12, 2016. Accessed April 29, 2024. https://www.qbtech.com/blog/fda-clears-breakthrough-adhd-test/
4. 510(k) summary of safety and effectiveness. FDA. PDF. March 24, 2014. Accessed April 29, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133382.pdf
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