Nucleic Acid Test versus Enzyme Linked Section Immunosorbent Assay for Screening of Human Immunodeficiency Virus in Donated Blood Units: A Comparative Study at a Blood Centre in Western Rajasthan, India

Abstract

Introduction: With a population of 1.3 billion people and a frequency of Human Immunodeficiency Virus (HIV) (0.17-0.29%), Hepatitis B Virus (3-4%), and Hepatitis C Virus (0.09-15%) in the general population, maintaining blood safety is a difficult undertaking in India. The fourth-generation Enzyme Linked Immunosorbent Assay (ELISA), which can be used in place of Nucleic Acid Amplification Test (NAT) testing in situations with limited resources, has been recommended as the minimal HIV test to increase the safety of blood transfusions. Aim: To compare the fourth generation ELISA with NAT in the screening of transfusion transmissible HIV infection in blood donors. Materials and Methods: A cross-sectional study was carried out at the Blood Centre, Department of Immuno-Haematology and Transfusion Medicine, Sardar Patel Medical College and Associated Groups of Hospitals, in Bikaner, Rajasthan, India. A total of 2000 voluntary and replacement blood donors were recruited consecutively between January 2020 to December 2021 (two years), and their samples were screened using fourthgeneration ELISA. All of these samples were sent to AIIMS in Jodhpur for NAT to identify HIV RNA, HCV RNA and HBV DNA. Results: In this study, when the fourth generation ELISA negative samples were subjected to NAT, no sample was found to be reactive for HIV in NAT, i.e. there was no NAT yield for HIV. Conclusion: As a bare minimum, the fourth-generation ELISA test should be used for blood donor screening and can be considered a cost-effective and reliable test in a resource limited setting. However, additional tests can be advocated for an additional layer of blood safety.