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
Babesia
- 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
Resources
- Blood Guidances | FDA
- Infectious Disease Tests | FDA
- Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion | FDA
- Bacterial Contamination of Platelets: Summary for Clinicians on Potential Management Issues Related to Transfusion Recipients and Blood Donors