Impact of nucleic acid testing in double screening of blood donations in Northern India: A single-center experience

Abstract

Objectives: The aim of our study is to assess the ability of nucleic acid testing (NAT) to detect hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) from donor blood samples which were declared sero-non-reactive. Materials and Methods: The whole blood donations were collected over the 6-year period from 2017 to 2023 which were initially screened for hepatitis B surface antigen, anti-HCV, anti-HIV-1/2, and p24 antigen and syphilis by electrochemiluminescence assays by Roche Diagnostics, Germany and malaria by Pan/Pf rapid test. Donations were declared nonreactive by these tests which were further subjected to NAT testing using minipool method. It was done in pool of 6 using cobas Taq Screen MPX version 2.0 on the cobas s201 platform. The NAT yields were quantitated for viral loads and followed up by serology. Statistical analysis: The data obtained was entered in Microsoft Excel and analyzed using descriptive statistics using the Statistical Package for the Social Science 21 version. Results: Out of 152,575 donations, 149,304 were sero-non-reactive and screened by NAT. Out of 82, 45 were reactive for HBV deoxyribonucleic acid and 37 for HCV ribonucleic acid. The NAT yield was 1:1831 overall, 1:3337 for HBV and 1:4059 for HCV. Viral load was quantitated in 65/82 NAT yields (35 HBV and 30 HCV). The viral loads of HBV samples were <20 IU/mL for 19/35 samples and the HCV sample viral loads ranged from 25.3 to 9.3 × 106 IU/mL. Eleven NAT-yield donors (4 HBV, 7 HCV) reported for follow-up showed sero-conversion between 90 and 210 days after NAT screening. Conclusions: This study confirmed the benefit of a highly sensitive minipool NAT (MP-NAT) in interdicting infectious donations undetected by conventional screening and illustrates the detection of donations with low viral loads using the MP-NAT polymerase chain reaction.