RESUMEN
Background: Hepatitis virus infections have many serious consequences like chronic hepatitis, fulminant hepatitis, liver cirrhosis, hepatocellular carcinoma and liver cancer. Serological test is thus necessary to identify hepatitis virus in the body. An observational study was conducted with an objective to detect hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus (HCV) antibodies by rapid card tests and to find the prevalence of co-infection with hepatitis B and hepatitis C viruses from January 2019 to June 2019.Methods: Blood samples were received from patients irrespective of age and sex, constituted the material for the present study. All samples were tested on hepacard and tri-dot card for the detection of hepatitis B virus and hepatitis C virus and results were interpreted as per Clinical Laboratory Standards Institute guidelines.Results: Out of 3488 samples, 254 samples were positive for hepatitis virus infection. Out of these 254 samples positive for hepatitis viruses, 22 (0.6%) patients were positive for hepatitis B virus and 232 (6.6%) patients were positive for hepatitis C virus. Only 2 (0.7%) of these patients showed co-infection with both viruses.Conclusions: Male patients showed more positivity of hepatitis virus as compared to females. Patients were more from outpatient department (OPD) as compared to inpatient department (IPD). Hepatitis virus infection was found to be highest in the age group 21-40 and lowest in the age group above 80 years. Both the co-infected patients were males and from IPD.
RESUMEN
Se evaluó el desempeño de un nuevo inmunoensayo de tercera generación para la detección de anticuerpos contra el virus de la Hepatitis C, HCV ELISA 3ª generación (Wiener-lab. Rosario. Argentina). Este equipo presenta reactivos coloreados para permitir el monitoreo de adición de muestras y control de procesos. Se evaluó la sensibilidad, especificidad y precisión de HCV ELISA 3ª generación mediante 5 paneles de seroconversión, 8 paneles de desempeño, 1 panel de sensibilidad para diferentes genotipos de HCV, 23 muestras de pacientes infectados con diferentes genotipos de HCV, 546 muestras de pacientes infectados, 556 muestras que contenían interferentes potenciales y 3.024 muestras de individuos no infectados. La sensibilidad en paneles de desempeño y en pacientes infectados fue 99,72%, y en muestras de pacientes infectados con diferentes genotipos fue 100%. La especificidad obtenida en muestras de donantes de sangre y Centros de Salud fue 99,50%. Finalmente, en los estudios de precisión se observó un coeficiente de variación intraensayo menor al 10%, e interensayo menor al 15% para muestras reactivas débiles. HCV ELISA 3ª generación, desarrollado por Wiener-lab, presenta un desempeño adecuado para el diagnóstico de la infección por HCV en el laboratorio serológico y en el tamizaje de donantes de sangre.
The performance of a new third-generation Anti-HCV, HCV ELISA third-generation (Wiener-lab. Rosario. Argentina), was evaluated. This kit presents sample addition monitoring and process control. Sensibility, specificity and precision of HCV ELISA 3ª generation were evaluated by means of 5 seroconversion panels, 8 performance panels, 1 worldwide HCV performance panel (which includes different HCV genotypes), on 546 samples of patients infected with HCV, 556 samples containing potentially interfering substances, and 3024 samples of persons not infected with HCV. Sensibility was 99.72% on performance panels and samples of HCV infected patients, and 100% on samples of patients infected with different genotypes. The specificity obtained from samples from blood donors and health centers was 99.50%. Finally, in precision studies the intra-assay coefficient of variation found was smaller than 10% and the inter-assay CV was smaller than 15% for weak reactive samples. In summary, HCV ELISA 3ª generation developed by Wiener-lab presents an adequate performance for the diagnosis of hepatitis C virus infection in clinical laboratory and blood donations screening.