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, explained how the object QbTest from Qbtech can add value to an ADHD diagnosis.1
"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
QbTest report sample | Image Credit: Qbtech
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
Click here to view results via the FDA's 510(k) summary of safety letter.
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
