Reduction of the risk of transfusion-transmitted viral infection by nucleic acid amplification testing in the Western Cape of South Africa: a 5-year review

Vox Sang. 2013 Feb;104(2):93-9. doi: 10.1111/j.1423-0410.2012.01640.x. Epub 2012 Aug 28.

Abstract

Background and objectives: In October 2005, individual donation nucleic acid amplification testing (ID-NAT) for HIV, HBV and HCV was introduced in the Western Cape Province of South Africa. After 5 years, the impact on HIV, HBV and HCV transmission risk was assessed.

Materials and methods: A total of 649745 donations were tested by ID-NAT using the Ultrio assay on the Tigris instrument (Novartis Diagnostics) and for anti-HIV, HBsAg and anti-HCV (Abbott Prism). Initial reactive samples were repeated in duplicate. Discrepant repeat reactive samples were subjected to confirmatory assays. ID-NAT nonrepeat reactive donations were further screened for occult HBV infection (OBI) by anti-HBc assay.

Results: ID-NAT yielded 6 HIV-RNA-positive donations in the anti-HIV-negative window period (WP) but only 2 were p24 Ag nonreactive (1:325000). Mathematical modelling estimated a similar HIV transmission risk for lapsed and repeat donations, in the order of 3 per million. The WP risk for HBV was 13 per million. Eight acute (1:81000) and 13 chronic OBI yield cases (1:50000) were interdicted. There were significantly more anti-HBc-positive donors in the Ultrio initial reactive/nonrepeat reactive group (12%) than in an Ultrio nonreactive control group (6%).

Conclusion: ID-NAT in the Western Cape Province of South Africa has contributed significantly to enhancing blood safety, particularly for HBV transmission risk and to a lesser extent for HIV. Anti-HBc testing of NAT nonrepeat reactive donations seems useful in identifying a subgroup of donors with OBI who may be at risk of transmitting HBV.

MeSH terms

  • Algorithms
  • Blood Donors
  • Blood Safety
  • Blood Transfusion / methods*
  • HIV Infections / blood
  • HIV Infections / prevention & control*
  • HIV Infections / transmission
  • Hepatitis B / blood
  • Hepatitis B / prevention & control*
  • Hepatitis B / transmission
  • Hepatitis C / blood
  • Hepatitis C / prevention & control*
  • Hepatitis C / transmission
  • Humans
  • Nucleic Acid Amplification Techniques / methods*
  • RNA, Viral / blood
  • Risk Factors
  • Serologic Tests / methods
  • South Africa
  • Transfusion Reaction

Substances

  • RNA, Viral