Breast Milk Donation Screening Tests
For breast milk donation screening, order serological testing for HIV-1, HIV-2, hepatitis B surface antigen (HBsAg), hepatitis C, syphilis, and human T-cell lymphotropic virus (HTLV-1 and HTLV-2).
Required Infectious Disease Screening Panel
The Human Milk Banking Association of North America guidelines specify that all human milk donors must be screened according to American Association of Blood Banks standards for blood donors 1. This translates to the following mandatory tests:
Core Serological Tests
- HIV-1 and HIV-2 antibody testing - Essential given documented transmission through breast milk and the 3.3% overall positive serology rate among potential donors 1, 2
- Hepatitis B surface antigen (HBsAg) - Required to detect active hepatitis B infection 1
- Hepatitis C antibody - Mandatory screening per tissue donation standards 1
- Syphilis serology - Required infectious disease screening 1, 3
- HTLV-1 and HTLV-2 antibody testing - Critical as these viruses transmit through breast milk 3, 4, 2
Additional Screening Considerations
- Cytomegalovirus (CMV) IgG testing - While not universally mandated, 62.3% of donors test CMV-IgG positive, and CMV-negative milk is specifically needed for very low birth weight immunocompromised infants 4
Testing Timing and Frequency
- Initial screening must be completed before any milk donation begins 3, 4
- Repeat testing every 3 months is required for ongoing donors to detect interval seroconversion 4
- Testing should use serum or plasma samples with FDA-licensed enzyme immunoassays 1
Clinical Context and Prevalence Data
The risk of positive serology is substantial - studies show 3.3% of potential donors screen positive for at least one infectious agent 2. Specific prevalence data from milk bank screening reveals:
- HIV prevalence ranges from 0-170 per 100,000 donors depending on time period and region 5
- Syphilis prevalence has increased significantly, reaching 1,749 per 100,000 in recent periods 5
- Hepatitis B (HBsAg) prevalence is approximately 230-300 per 100,000 donors 5
- Anti-HBc (lifetime hepatitis B exposure marker) affects 3,874-7,339 per 100,000 donors 5
These data underscore why peer-to-peer milk sharing without screening poses significant infectious disease transmission risk 2, 6.
Important Caveats
- Donors must also undergo behavioral risk screening for HIV acquisition behaviors and physical examination for signs of infection, though these are clinical assessments rather than laboratory tests 1
- Any positive screening test result permanently excludes the donor from milk donation 3, 4, 2
- The window period between infection and antibody seroconversion (4 weeks to 6 months for HIV) means even screened donors carry minimal residual risk 1
- Pasteurization of donated milk inactivates HIV and reduces other infectious risks, though it also diminishes some beneficial milk properties 1, 3