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

• Published in: Journal of basic microbiology 2000-01, Vol.40 (1), p.25-32
• Main Authors: García Jr, Fernando, García, Federico, López, Inmaculada, Bernal, Carmen, Hernandez, Jose, García-Valdecasas, Juan, Piédrola, Gonzalo, Maroto, Carmen
• Format: Article
• Language: English
• Subjects: AIDS/HIV; Flaviviridae - isolation & purification; Hepatitis C, Chronic - complications; Hepatitis C, Chronic - drug therapy; Hepatitis, Viral, Human - complications; Hepatitis, Viral, Human - diagnosis; HIV Infections - complications; Humans; Reagent Kits, Diagnostic; Reproducibility of Results; Reverse Transcriptase Polymerase Chain Reaction - methods; Sensitivity and Specificity
• ISSN: 0233-111X; 1521-4028
• DOI: 10.1002/(SICI)1521-4028(200002)40:1<25::AID-JOBM25>3.0.CO;2-G

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 evalua‐tion 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 con‐cordance 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.