A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple biochemical markers associated with traumatic brain injury in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid electrochemical immunoassay method [excludes immunochromatographic tests (ICT)]. This test is commonly used in the laboratory or in point-of-care analyses to detect glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) as an aid to determine the need for a neuroimaging scan following head injury. It is not intended to be used for self-testing.
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