“…Total nucleic acid (TNA) was extracted from RNARetain-preserved FNAs using a proprietary laboratory-validated method and quantified using a NanoDrop ND1000 (NanoDrop Technologies, Waltham, MA). DNA-and RNA-based tests were performed using 20 or 40 ng of purified TNA, a single qualitative multiplex assay system based on the Signature technology platform (17)(18)(19) and reagents developed, manufactured, qualified, and released under controlled processes by Asuragen Inc., Austin, Texas. To generate qualitative positive or negative test results, assay outputs (median fluorescence intensity signals) were interpreted relative to target-specific, predetermined, laboratory-validated qualitative cutoff values corresponding to an analytical sensitivity of 0.5% to 2.5%.…”