Infectious Disease Testing

Two techniques are used to detect infectious disease. Serological testing, the industry standard, looks for the presence of the body's reaction (antibodies) to an infection. The other methodology, pioneered at Fairfax Cryobank is Polymerase Chain Reaction (PCR) testing (also called NAT for Nucleic acid Testing), a far more sensitive method which uses molecular genetic techniques to identify for the presence of the DNA of the infecting agent. Fairfax Cryobank makes the most extensive use of any sperm bank of PCR technology to test for infectious diseases. All donor specimens are quarantined for six months. The donor must then return and be retested for a panel of infectious diseases before his specimens can be released from quarantine. We follow the FDA regulations effective in May 2005 which clearly stipulate the testing protocols on donor infectious disease testing.

The following infectious diseases are tested in every donor active after 5/25/05:

Serological testing:

• HIV-1 and HIV-2 antibody
• Hepatitis B surface antigen and core antibody
• Hepatitis C antibody
• Cytomegalovirus (CMV) antibody
• Syphilis (RPR)
• HTLV-I and II antibody*

Polymerase Chain Reaction (PCR) NAT testing:

• HIV 1 & 2
• HTLV I & II
• HCV *
• Chlamydia *
• Gonococcus *
• Cytomegalovirus*
• Herpes simplex virus 1 & 2 (HSV)
• Human papillomavirus (HPV)
• Adenovirus, trichomonas, candida and actinomyces are tested when indicated.

Due to test availability at the time of donation, a given donor may not have been tested for the tests marked with a (*) by the methodology indicated but all donors have been tested for the above diseases.