Use of supplemental anti-HBc testing of donors showing non-discriminating reactive results in multiplex nucleic acid testing

Vox Sang. 2017 Oct;112(7):622-627. doi: 10.1111/vox.12553. Epub 2017 Sep 10.

Abstract

Background and objectives: The Korean Red Cross began nucleic acid amplification testing (NAT) for HIV and HCV in February 2005, and added HBV NAT beginning in June 2012. The current NAT system utilizes a multiplex assay for simultaneous detection of HBV DNA, HCV RNA and HIV-1 RNA. For samples that are reactive in the multiplex assay, we do specific tests for each virus. However, there have been cases of non-discriminated reactive (NDR) results which appear to be the result of non-specific reactions or cross-contamination, although some cases are considered to arise from the presence of low levels of HBV DNA due to occult hepatitis B infection.

Materials and methods: We examined the incidence of NDR results in previous donations of some NAT-reactive donors. Additionally, for those donors with NDR results, we performed an HBV core antibody (anti-HBc) assay.

Results: From November 2015 to March 2016, there were 408 NAT-reactive donors. Of these, nineteen HBV NAT-reactive donors showed a history of NDR results in the past donations. Seven donors showed NDR results more than once. Of 771 NDR donors, 362 (47·0%) were anti-HBc reactive.

Conclusion: The NDR donors had a substantially higher rate of anti-HBc reactivity than other blood donors indicating that some with anti-HBc reactivity represent donors with occult HBV. Therefore, the incorporation of an anti-HBc testing for NDR donors could improve blood safety testing for the Korean Red Cross.

Keywords: blood safety; nucleic acid amplification testing; transfusion-transmissible infections.

MeSH terms

  • Blood Donors*
  • DNA, Viral / blood
  • Donor Selection / methods*
  • Donor Selection / standards
  • Hepatitis B / blood*
  • Hepatitis B Antibodies / blood*
  • Hepatitis B virus / genetics
  • Humans
  • Nucleic Acid Amplification Techniques / methods*
  • Nucleic Acid Amplification Techniques / standards
  • Serologic Tests / methods*
  • Serologic Tests / standards

Substances

  • DNA, Viral
  • Hepatitis B Antibodies