CLINICAL VALIDATIONS
CLICK EACH LINK BELOW FOR FULL CLINICAL
VALIDATION AND RELATED PUBLISHED STUDIES
Clinical Use Studies Observing the Utility Potential and Manufacturing Process Evaluation of FDA Class 2 Medical Device MSP My Safe Pass™, Utility 5-Scent Odorant Olfactory Test Kit Click to view
MSP Utility Product Validation and Use Study
OPINION Dr. Revinder Ravi. "My opinion suggests that Medical providers should offer the MSP test to their patients as a standard of care objective exam to assist in the diagnosis in suspected viral etiologies, neurodegenerative, and traumatic brain injury. I also agree that the MSP test can potentially be used in providing early-stage detection of potential genetic neurological disorders. I strongly feel that this objective exam is a vital tool to bring a cost-effective solution to an objective ENT exam in a physician's protocol." click below for the complete MSP Clinical use study and review.
VALIDATIONS AND CLINICAL STUDIES
MSP 5 SCENT ODORANT OLFACTORY TEST VALIDATIONS.
5 SCENT ODORANT IN MULTIPLE CLINICAL STUDIES INCLUDING:
• Latest Clinical Review and recommendation Dr. Ravi Reddy. MSP product review testing
• FDA Medical Device Registration validation.
• MSP exceeds minima odorant detection requirements.
• 1 Institute of Clinical Pharmacology, Goethe –Oxford
• Odorant Testing Requirements protocol. St Croix Sensory Inc.
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Concussion/TBI –The First and Sometimes the only symptom of Mild to Moderate Concussion
Neurological Olfaction Correlations
(Alzheimer’s Parkinson’s 140 other Neurodegenerative).
National Library of Medicine- National Center for biotechnology Information J Alzheimer's Dis.2022;86(3):1275-1285.
doi: 10.3233/JAD-210636.
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Olfactory Dysfunction in Neurodegenerative Diseases.Marin C, Vilas D, Langdon C, Alobid I, López-Chacón M, Haehner A, Hummel T, Mullol J.
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Olfaction as an early marker of Parkinson's disease and Alzheimer's disease.Walker IM, Fullard ME, Morley JF, Duda JE.Handb Clin Neurol. 2021;182:317-329. doi: 10.1016/B978-0-12-819973-2.00030-7.PMID: 34266602
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Olfactory,Concussion, cognitive and affective dysfunction assessed 24 hours and one year after a mild Traumatic Brain Injury (mTBI)
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Traumatic brain injury and olfaction: a systematic review
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Increases of phospho-Tau (Ser202/Thr205) in the olfactory regions are associated with impaired EEG and olfactory behavior in traumatic brain injury mice
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1 Clinical validation of an open-access SARS-COV-2 antigen detection lateral flow assay, compared to commercially available assays
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The usefulness of a quantitative olfactory test for the detection of COVID-19. World’s leading institutes in Studies of Infections Disease and Public Health)
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Modeling the effectiveness of olfactory testing to limit SARS-CoV-2 transmission
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Smell loss may precede a Parkinson's diagnosis by up to 10 years. Lasting smell loss can be a risk factor for brain disease. PPMI Clinical Study​
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644 associated clinical studies-Olfactory disorder Parkinson's disease NIH NLOM Clinical PMC Olfaction Disorder and Alzheimer's Disease Studies
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Olfaction as an early marker of Parkinson's disease and Alzheimer's /pubmed.ncbi.nlm.nih.gov/34266602/
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Loss of smell linked to Alzheimer’s cognitive impairment and biomarkers. NIH Link to Clinical Studies Olfaction Disorder and Viral Infection
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The overwhelming majority—approximately 86% of people—who have COVID-19 report either partial or total loss of their ability to smell.
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Olfaction Disorder and Concussion
“It's long been known that people who suffer a major concussion can lose their sense of smell temporarily” Sciencedaily.com -
Olfactory, cognitive and affective dysfunction assessed 24 hours and one year after a mild Traumatic Brain Injury (mTBI)
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developments have led to the proliferation of standardized olfactory testing in laboratories and clinics, and to the discovery that smell loss is among the first signs of a number of neurodegenerative diseases, including Alzheimer's disease and idiopathic Parkinson's disease. https://pubmed.ncbi.nlm.nih.gov/11148312