Validation
What are the dogs smelling?
We're working to find out.
How accurate are the dogs?
Every sample is screened by two separate dogs. Results are reported as:
NEGATIVE: Neither dog identified the sample.
POSITIVE: Both dogs identified the sample.
INDETERMINATE: There was disagreement between the dogs.
To determine the dogs' ability to accurately identify samples of individuals with Parkinsonism, TRUE POSITIVES (unilateral onset, levodopa-responsive, DatScan +) and TRUE NEGATIVES (no symptoms of motor or non-motor PD) were compared.
In the study of 30 samples (15 PwP, 15 controls), Cocoa never missed a positive (100% sensitivity). Approximately 27% of the time, she said "yes" to a healthy control (73% sensitivity).
Why do the dogs say "Yes" to some people without Parkinsonsim?
We don't know and we're working to find out.
The dogs may be playing us to get more treats, they may be smelling something not specific to Parkinsonism (e.g. constipation, seborrhea), or they may be identifying people who truly are positive but have yet to develop any symptoms.
Is the ParK-9 Clinical Laboratory Improvement Amendments (CLIA) nonregulated?
The Washington State Department of Health has determined that this technique is not a clinical laboratory test and therefore, is not subject to regulation under CLIA.
Is this test covered by insurance?
Not yet.