CSF Sample-to Answer Validation Studies Using Focus Diagnostics’

The Simplexa™ HSV 1 & 2 Direct assay detects and differentiates HSV-1 and HSV-2 from CSF specimens in about an hour, without prior extraction. Performance studies were conducted including LoD, cross-reactivity, inhibition, interference, reproducibility, and positive and negative agreements. Analytical sensitivity was less than 50 TCID[50]/mL and positive agreement was 100%.