CSF Sample-to Answer Validation Studies Using Focus Diagnostics’
21 May 2014The 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%.
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Simplexa™ HSV 1 & 2 Direct Kit
Focus Diagnostics IncA real-time PCR assay for the in vitro qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of Herpes Simplex Virus (HSV) infections of the central nervous system (CNS). Extraction and amplification is performed in one protocol with no separate nucleic acid extraction step. Each kit includes three Direct Amplification discs. This product achieved moderate complexity status for use in CLIA moderate and high complexity healthcare facilities.