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Validation of the GeneSeq HCV NS5B Sequencing Assay for Patient-Derived HCV Subtypes 1a and 1b
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Reported by Jules Levin
EASL April 2010
Sunny Choe, Dong Han, Muzong Cheng, Elizabeth Anton, Eric Stawiski, Elicia Penuel, Neil Parkin, Christos J. Petropoulos, and Jacqueline D. Reeves*
Monogram Biosciences, Inc.
South San Francisco,
CA, USA
BACKGROUND and AIMS
Monogram Biosciences has developed the GeneSeq HCV NS5B assay to evaluate resistance to HCV polymerase inhibitors. This assay determines the entire nucleotide and derived amino acid
sequence of the NS5B region of HCV subtypes 1a and 1b from patient plasma samples. Amino acid differences relative to a subtype-specific reference sequence are reported. The technical performance of the assay was characterized in validation experiments designed to assess assay accuracy, precision, reproducibility, sensitivity for amplification and detection of minor species, linearity and specificity.
Figure 4: Determination of Amplification Sensitivity
Figure 5: Sensitivity for Detection of Low Level Polymerase Inhibitor Resistance Mutations
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