Abstract
Current treatment guidelines recommend HBV genotypic resistance testing for patients who experience primary or secondary virological failure while receiving nucleoside or nucleotide therapy. In this study we evaluate performance of ACL LDT HBV genotype assay and SeqHep B software for drug-resistance detection. Forty-nine HBV positive specimens were tested using ACL LDT HBV genotype (HBVGT) assay and compared to RUO commercial kits; ACL LDT HBVGT sequencing assay (ACL), TruGene HBV Genotyping kit (Siemens) (TG) and Abbott HBV RUO sequencing assay (AB). All “consensus sequences” were analyzed for HBV genotype and drug resistance profile by third-party analysis software. The ACL HBVGT assay performance was evaluated by assessing analytical specificity, sensitivity, potential interfering substances, and accuracy. ACL LDT HBVGT produced 100% clinical sensitivity (49/49) on samples with viral load in range 160–400,000,000 UI/mL, analytical sensitivity 100% at VL = 400 IU/mL for HBV (A-H) genotypes, analytical specificity 100% (11/11) potentially cross-reactive microorganisms/viruses. HBV genotypes and drug resistance reports were generated based on latest HBV resistance database SeqHepB Ver:13.1 (Sep 2011—Reportable Mutations Version 5.0) from ABL SA (Advances Biological Laboratories) https://www.ablsa.com/. All genotypes and drug resistance reports were verified by alternative HBV database and software Geno2Pheno (hbv) v2.0 (Oct 2013)—from Max Plank Institute—Germany http://hbv.bioinf.mpi-inf.mpg.de/—all reports matched 100%. HBV genotypes were verified based on following GenBank databsae; Type A = X02763, B = D00330, C = AB033556, D = X02496, E = X02496, F = X75663, G = AF160501, H = AY090460. This study demonstrates that the ACL LDT HBV sequencing assay is a highly sensitive and reproducible method for detecting HBV genotype and determination of drug-resistance status. We selected this assay for implementation because of its solid performance, custom workflow and instrumentation as well as economics.
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