IMMY’s CrAg lateral flow assay (LFA), approved by the FDA in 2011, is an immunochromatographic dipstick assay that detects the presence of the CrAg antigen without requiring laboratory infrastructure.
IMMY’s CrAg LFA test is fast and accurate with a turnaround time of 10 minutes and a 100% sensitivity and specificity in serum and CSF samples, both of which are samples approved by the FDA for the test. Despite its performance, it is still recommended to confirm a positive diagnosis with a lumbar puncture.
This document summarizes the global challenges and recommendations for implenting CrAG LFA.