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

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(R) GBV-C Assay (LCx). GB Virus C RNA was detected by at least o ne test in 58/315 samples (18.41%). Fifty-five samples (17.46%) were positi ve by the GEN method and 51 samples (16.19%) by the LCx method. The same ra te of detection was found for 71 haemodialysis patients and IS 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 7/10 6 (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 method s, with two samples discordant. Overall, discordance was observed for ten s amples, with seven positive only by the GEN ETI-K HGV RNA, and three positi ve only by the LCx GBV-C Assay. An additional evaluation of serial samples, from chronic type C hepatitis patients under interferon treatment, reveale d three samples which were positive only by the GEN method. Results were 10 0% concordant for patients under haemodialysis and for non-A non-E hepatiti s, 95.9% in the HIV positive group, 90.9% in the chronic type C hepatitis g roup, and 97.1% in the general population group. Overall. a 97.2% of concor dance was found between methods. Both tests have a similar diagnostic perfo rmance, though in our opinion, LCx GBV-C Assay better suits the requirement s of a clinical microbiology diagnostic laboratory.