Evaluation of two reverse transcription polymerase reaction assays (GEN ETI-K HGV RNA and LCx GBV-C assay) for the detection of GB Virus C/Hepatitis G Virus RNA in clinical samples

Abstract

Our study evaluates the analytical performance of two amplification methods in the detection of GB Virus C/Hepatitis G Virus, GEN ETI-K HGV RNA (GEN) and the LCx GBV-C Assay (LCx). GB Virus C RNA was detected by at least one test in 58/315 samples (18.41%). Fifty-five samples (17.46%) were positive by the GEN method and 51 samples (16.19%) by the LCx method. The same rate of detection was found for 71 haemodialysis patients and 18 non-A non-E hepatitis. Method based differences in prevalence were observed for patient samples from the general population, 8/106 (7.55%) positive by GEN vs 7/106 (6.60%) by LCx; and HIV infected patients, 26/98 (26.53%) vs 23/98 (23.46%). For chronic type C hepatitis 10/22 (45.5%) were positive by both methods, with two samples discordant. Overall, discordance was observed for ten samples, with seven positive only by the GEN ETI-K HGV RNA, and three positive only by the LCx GBV-C Assay. An additional evaluation of serial samples, from chronic type C hepatitis patients under interferon treatment, revealed three samples which were positive only by the GEN method. Results were 100% concordant for patients under haemodialysis and for non-A non-E hepatitis, 95.9% in the HIV positive group, 90.9% in the chronic type C hepatitis group, and 97.1% in the general population group. Overall, a 97.2% of concordance was found between methods. Both tests have a similar diagnostic performance, though in our opinion, LCx GBV-C Assay better suits the requirements of a clinical microbiology diagnostic laboratory.