Evaluation of Performance Characteristics of Enzyme Chemiluminescence Immunoassay (ECLIA) and Rapid Diagnostic Test (RDT) for HBV, HIV and HCV Infections DC14-DC17
Dr. Sudipta Roy,
Assistant Professor, Department of Microbiology, IQ City Medical College, Bijra, Durgapur-713206, West Bengal, India.
Introduction: The incidence of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) in India has increased over the past two decades. These infections cause significant mortality and morbidity. This increasing trend is alarming and is emerging as a global health problem. India has one of the largest reservoirs of HIV, HBV and HCV and many of its cases remain undetected. Due to the large sero-prevalence in India, serological tests for HBsAg, anti-HCV and anti-HIV are done for diagnosing the respective diseases, and screening of antenatal, preoperative cases and of blood donors.
Aim: To find out the efficacy of Rapid Diagnostic Test (RDT) and Enzyme Chemiluminescence Immunoassay (ECLIA) in comparison to Enzyme Linked Immunosorbent Assay (ELISA) for diagnosis of HBV, HCV and HIV infections in patients.
Materials and Methods: This cross-sectional study presented a comparative analysis of test results of HBsAg, anti-HCV and anti-HIV antibodies by different methods namely RDT and ECLIA taking ELISA as reference standard. A total of 198 serum samples were taken from patients and tests were done for HBsAg, anti-HCV and anti-HIV by three different methods i.e. ECLIA, RDT and ELISA and sensitivity, specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV) and accuracy were calculated. The agreement between the results was computed using Kappa coefficient.
Results: The findings demonstrated that for HBsAg, the results of RDT and ECLIA were same. For anti-HIV 1 and 2, sensitivity of RDT and ECLIA was similar. For anti-HCV, ECLIA showed better sensitivity than RDT and RDT showed better specificity than ECLIA. Strength of agreement was almost perfect for HBsAg and anti-HIV, where as for anti-HCV it was substantial.
Conclusion: There were some variations in certain results by different methods. It was observed that RDT and ECLIA are good screening tests for HIV and HBV infections. On the other hand, we inferred that for HCV, ECLIA is a better screening test than RDT.