NATSpert ID TripleH: A novel individual donor multiplex nucleic acid amplification test to reduce risk of transfusion-transmitted infections: Two-year experience of a blood bank in central India

Abstract

Background: In India serological screening is mandatory for all donated blood for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) while Nucleic Acid Amplification Testing (NAT) is not a mandatory screening test. There is a risk of transfusion-transmitted infections (TTI) during window period using serology. Aims and Objectives: The aim of this study was to analyse NAT screening using an indigenously developed, Indian manufactured Individual Donor NAT (ID-NAT) and compare it with serology. Materials and Methods: All blood donations between June 2017-March 2019 were screened serologically for HBV, HCV and HIV at an Indian blood bank. Blood donations also underwent ID-NAT screening using the NATSpert ID TripleH detection assay based on real time PCR. The results were analysed to identify yield cases. Results: In the study, 30,772 blood donor samples were screened serologically out of which 214 were reactive. 30,558 serologically non-reactive blood donations and 77 randomly selected, serologically reactive blood donations were screened using NATSpert. Out of 30,635, 85 donor samples were reactive on the NATSpert which included 77 serology positive and 8 NAT yield cases. The NAT yield found was 2 each for HBV/HIV and 4 of HCV. Conclusion: The NATSpert ID TripleH offers a statistically significant advantage over EIA in ability to detect TTI in blood donors (P < 0.05, Fishers Exact Test). The NAT yield of 1:3829 was in line with other Indian studies. NATSpert assay will provide a significant improvement in blood safety and offer a cost benefit compared to the imported products.