Individual donor nucleic acid testing for blood safety against HIV-1 and hepatitis B and C viruses in a tertiary care hospital.

ABSTRACT

Background. In July 2010, we started universal individual donor nucleic acid testing (ID-NAT) at our blood bank. This test simultaneously detects human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) in samples of donor blood. We continued to do the enzymelinked immunosorbent assay (ELISA) test for these agents, as per the guidelines of the Drug Controller General of India. We assessed the impact of ID-NAT in preventing transfusionassociated transmission of viruses. Methods. We used fourth generation ELISA to screen blood samples of all voluntary and replacement blood donors. ID-NAT was done by transcription-mediated amplification (TMA). Results. Of the 18 356 donors, ID-NAT could not be performed on 2 samples which were inadequate. Of the 18 354 donors tested by both ID-NAT and fourth generation ELISA, 7 were found to be NAT-positive but ELISA-negative (NAT yield) for HBV and HCV. The prevalence of NAT yield cases among routine donors was 1 in 2622 donations tested (0.038%). Since we supply blood as components (packed red cells, fresh frozen plasma and platelet concentrate), these 7 units of blood would have yielded 21 components and hence 21 patients could have been infected with HBV and HCV viruses. Conclusion. In the vast majority of blood units tested, the results of ELISA and ID-NAT for HIV-1, HBV and HCV were concordant. ID-NAT did detect the presence of viruses missed by ELISA in some blood units. It widespread use in blood banks would ensure safer blood transfusion.