Abstract

BackgroundHIV, HBV and HCV pose a major public health problem throughout the world. Detection of infection markers for these agents is a major challenge for testing laboratories in a resource poor setting. As blood transfusion is an important activity saving millions of live every year, it also carries a risk of transfusion transmissible infections caused by these fatal blood borne pathogens if the quality of testing is compromised. Conventional ELISA is regarded as the mostly used screening technique but due to limitations like high cost, unavailability in many blood banks and testing sites, involvement of costly instruments, time taking nature and requirement of highly skilled personnel for interpretation, rapid tests are gaining more importance and warrants comparison of performance.ResultsA comparative study between these two techniques has been performed using commercially available diagnostic kits to assess their efficacy for detection of HIV, HBV and HCV infections. Rapid kits were more efficient in specificity with synthetic antigens along with high PPV than ELISA in most cases. Comparison between different ELISA kits revealed that Microlisa HIV and Hepalisa (J. Mitra & Co. Pvt. Ltd.); ERBA LISA HIV1 + 2, ERBA LISA Hepatitis B and ERBA LISA HCV (Transasia Bio-medicals Ltd.) gives uniform result with good performance in terms of sensitivity, specificity, PPV, NPV and efficiency, whereas, Microlisa HCV (J. Mitra & Co. Pvt. Ltd.), Microscreen HBsAg ELISA and INNOVA HCV (Span Diagnostics Ltd.) did not perform well. Rapid kits were also having high degree of sensitivity and specificity (100%) except in HIV Comb and HCV Comb (J. Mitra & Co. Pvt. Ltd.). The kit efficiency didn’t vary significantly among different companies and lots in all the cases except for HCV ELISA showing statistically significant variation (p < 0.01) among three kit types.ConclusionsELISA is a good screening assay for markers of HIV, HBV and HCV infections. Rapid tests are useful for further detection of false positive samples. ELISA seems the appropriate assay in blood bank. For availability of quality commercial diagnostic assays, evaluation of kit may be helpful.

Highlights

  • Human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) pose a major public health problem throughout the world

  • Rapid kits were more efficient in specificity with synthetic antigens along with high Positive Predictive Value (PPV) than enzyme linked immunosorbent assay (ELISA) in most cases

  • ELISA seems the appropriate assay in blood bank

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Summary

Introduction

HIV, HBV and HCV pose a major public health problem throughout the world. Detection of infection markers for these agents is a major challenge for testing laboratories in a resource poor setting. As blood transfusion is an important activity saving millions of live every year, it carries a risk of transfusion transmissible infections caused by these fatal blood borne pathogens if the quality of testing is compromised. Human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) are the most threatening blood borne pathogens which have proved to be major risk factors for transfusion transmissible infections in human population. Blood transfusion is an important activity that saves millions of live every year [1]. Still it carries risk of transfusion associated diseases like hepatitis, acquired immunodeficiency syndrome (AIDS) and some other blood borne sexually transmitted diseases [2,3]. It has been estimated that the global prevalence of Hepatitis C virus (HCV) infection is around 2%, with million persons chronically infected with the virus and 3 to 4 million persons newly infected each year [13]

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