Abstract
Background and Objective:Blood transfusion is an essential and life-saving medical intervention. Despite multiple preventive measures transfusion-transmitted hepatitis C virus (HCV) infection continues to be a major healthcare issue in Pakistan. This study was conducted at National Institute of Blood Diseases & Bone Marrow Transplantation to evaluate the frequency of active HCV infection with or without co-infection in blood donors and also to determine comparative efficacy of Multisure HCV antibody assay (MHAA); a new serological device.Methods:A total of 14652 blood donors visiting National Institute of Blood Diseases & Bone Marrow Transplantation (NIBD) Blood Bank from January 2013 to July 2014 were enrolled and screened for a range of blood borne infections such as HBV, HCV, HIV, malaria and syphilis. The HCV was screened simultaneously by Abbot Architect anti-HCV assay (CLIA) and MHAA. The active HCV infection was confirmed by nucleic acid testing (NAT) in reactive donors. Later; for determination of comparative efficacy of MHAA; all NAT positive samples were further tested using Monolisa™, HCV blot 3.0, Anti-HCV plus V2 and Anti-HCV-MPBIO-EIA.Results:The HCV reactive sera were observed in 1.563% (226) donors. The NAT confirmed active HCV infection in 138 donors. Overall 27.84% of HCV positive donors exhibited co-infection either with HBV (2.57%), syphilis (22.78%). Triple infection was not observed in any donor. The efficacy of MHAA is comparable to all the serological tests with a sensitivity of about 96.89%.Conclusion:Active HCV infection was present in 0.94% donors. With a sensitivity of 96.89% (95% CI: 95.66-98.12) the multi-parametric device MHAA can effectively detect HCV infection in donors. Thus, it can be used in limited health care settings for HCV screening.
Highlights
Liver disease due to Hepatitis C virus (HCV) is a common global infection.[1]
This cross sectional study was conducted at the Department of Immunology, National Institute of Blood Diseases & Bone Marrow Transplantation (NIBD) after approval by ethical review committee of NIBD Karachi
The hepatitis C virus (HCV) reactive patients by any of these assays were further screened for active HCV infection by the gold standard HCV nucleic acid testing (NAT) using artus® RG RT-PCR kit
Summary
Liver disease due to Hepatitis C virus (HCV) is a common global infection.[1]. Out of the estimated 130-170 million HCV affected people about 8.6 millions are Pakistanis.[2,3] HCV is a positive sense single stranded RNA virus discovered in 1980’s as non-A and non-B hepatitis virus. The Abbott Architect chemiluminescence immune-assay (CLIA) can detect and quantify HCV core antigen in an automated manner.[11] It can be effectively used in resource constrained settings It is less sensitive than the HCV RNA detection by PCR which is the gold standard for HCV detection and monitoring of treatment as per guidelines by WHO.[12] Over the time, several combination assays like Monolisa antigen/antibody Ultra have been developed which can simultaneously detect antibodies and core antigen of HCV. The WHO lays especial emphasis on screening of blood and blood products for all transfusion transmissible infections (TTI) such as HCV, HBV, HIV, syphilis, malaria etc.[12] In most blood centers with limited laboratory setup rapid devices are generally used for initial screening of infected donors These rapid tests are cheap alternative of combination or third generation enzyme immune-assays (EIA).[14]. Multisure HCV antibody assay is developed for the detection and differentiation of HCV antibodies into core, NS3, NS4 and NS5
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