Adult Emergency Room Laboratory, Traumatic Brain Injury Acute Biomarkers

• The i-STAT TBI test is not intended to be used as a stand-alone device but as an adjunct to other clinical information to aid in the evaluation of patients who are being considered for standard of care neuroimaging.
• A ‘Not Elevated’ result is generally associated with the absence of acute intracranial lesions. An appropriate neuroimaging method is required for diagnosis of acute intracranial lesions.
• Samples from patients who have been exposed to animals or who have received therapeutic or diagnostic procedures employing immunoglobulins or reagents derived from immunoglobulins may contain antibodies, e.g., HAMA or other heterophile antibodies, which may interfere with immunoassays and produce erroneous results. The generation of potentially interfering antibodies in response to bacterial infections has been reported. While this product contains reagents that minimize the effect of these interferents and QC algorithms designed to detect their effects, the possibility of interference causing erroneous results should be evaluated carefully in cases where there are inconsistencies in the clinical information.
• The test results should be assessed in conjunction with the patient's symptoms, clinical examination, and other findings. If results appear inconsistent with the clinical assessment, the patient sample should be retested using another cartridge.