Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of Tau phosphorylated at threonine 181 (pTau 181) in human cerebrospinal fluid (CSF).
This CSF biomarker is intended to be used as an aid for diagnosis in patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.
The CSF biomarker supports the probability of AD pathology only as an adjunct to other diagnostic evaluations.
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