Perry Roy, MD, explains how an FDA-cleared objective test can assist in an ADHD diagnosis.
"We know that treating ADHD prior to adolescence is about a 90% reduction in future depression, anxiety, and also future substance use disorders" said Perry Roy, MD, of Carolina Attention Specialists, Charlotte, North Carolina in this video interview with Contemporary Pediatrics, highlighting the important role early diagnosis of ADHD can play.
An objective testing tool only strengthens the diagnosis, said Roy. The QbTest from Qbtech is an FDA-cleared test for diagnosis and treatment evaluation of core ADHD symptoms cleared for individuals aged 6 to 60 years.1
"It's an objective test, so it adds value to the diagnosis," said Roy. "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."
The QbTest was granted FDA 510(k) clearance in 2014, with an intended use to provide "objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD," according to the FDA clearance summary of safety report.2,3
"Like any test in medicine, it is very important to have a very sensitive and specific test to help diagnose... The rating scales, which have been historically used, and we use them in our office as a tool, [the] sensitivity is 70% at best, specificity in the 20% to 30% [range]," added Roy.
"This test is objective, it adds specificity and sensitivity to the diagnosis."
According to Qbtech, testing takes 15 to 20 minutes with results delivered in a visual report. Results compare the patient's results to individuals without ADHD in patient's respective age range and gender.1
Reference:
1. Qbtech fact sheet from Qbtech. Qbtech. PDF.
2. 510(k) summary of safety and effectiveness. FDA. PDF. March 24, 2014. Accessed April 25, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133382.pdf
3. FDA clears both QbTest and QbCheck. Qbtech. April 12, 2016. Accessed April 25, 2024. https://www.qbtech.com/blog/fda-clears-breakthrough-adhd-test/