Clinical Testing Guidance for Blood Safety

Key points

  • All blood donations are tested for multiple disease markers, including, but not limited to, Hepatitis virus types, HIV, West Nile virus and Zika virus.
  • Bacterial contamination of blood products, especially in platelets that are stored at room temperature, is the most common infectious risk of blood transfusion, occurring in approximately 1 in every 2,000-2,500 platelet transfusions.
  • Other diseases and organisms that can be transmitted by blood transfusion include parasitic diseases, viral diseases and prion diseases.

Testing guidelines

Infectious Disease Pathogen & Laboratory Tests Used

Note: all laboratory tests conducted at each donation unless otherwise specified.

Hepatitis B virus (HBV)
  • Hepatitis B surface antigen (HBsAg) assay
  • Total antibody to hepatitis B core antigen (anti-HBc) assay Nucleic acid testing for HBV
Hepatitis C virus (HCV)
  • Antibody to hepatitis C virus (anti-HCV) assay
  • Nucleic acid testing for HCV
  • Enzyme-Linked Immunosorbent Assay (ELISA) for HCV
Human Immunodeficiency virus (HIV) Types 1 and 2
  • Antibodies to HIV-1 and HIV-2 (anti-HIV-1 and anti-HIV-2) assay
  • Nucleic acid testing for HIV-1
Human T-Lymphotropic Virus Types I and II (HTLV)
  • Antibodies to Human T-Lymphotropic Virus types I and II (Anti-HTLV-I/II) assay
Treponema pallidum (syphilis)
  • Anti-treponemal antibody detection
West Nile virus (WNV)
  • Nucleic acid testing for WNV
Trypanosoma cruzi (Chagas disease)
  • Anti-T. cruzi assay
  • Testing frequency - All first-time donors
Cytomegalovirus (CMV)
  • Anti-CMV assay
  • Testing frequency - Performed on some donations for special needs recipients
  • Nucleic acid test Babesia species and antibody for B. microti
  • Testing frequency - Performed on donations in Babesia-endemic regions
Bacterial Contamination
  • Risk control strategies as specified by FDA guidance
  • Testing frequency - See FDA guidance