Tissue used in research provided by donors whose blood is tested by serologic methods for Hepatitis B (HBV), Hepatitis C (HCV) and HIV-1 (HIV) and a negative result is relied on to release the tissue for research. Yet, transmission of HBV, HCV and HIV from serologically negative donors have been documented.

SeraCare BioServices' HBV, HCV and HIV Donor Tissue Safety Testing Service can reduce the risk of inadvertent use and scale of tissue from HBV, HCV or HIV positive donors.

How can SeraCare's Donor Tissue Safety Testing Reduce your Risk?

Serological testing detects antibodies to the infectious agent, a positive result meaning that the donor has been exposed, and produced antibodies to, infectious agent(s). But, individuals can be infected with HBV, HCV or HIV and their blood and tissue can infect those who contact it, even months before antibodies appear in blood. That's the reason that, throughout the developed world, serologic testing is no longer solely relied upon to eliminate infectious units from blood supply; Nucleic Acid Testing (NAT) was initiated on blood donations in 1999. NAT's superiority arises largely because of the "Window Period".

Window Period refers to the time period between exposure to an infectious agent and detection of an indicator of that exposure. The Window Period for detecting antibodies to HBV, HCV and HIV is typically several weeks and all too-often is months. This prolonged Window Period occurs because the host's (donor's) immune system can require weeks after infection to produce antibodies, for reasons that range from characteristics of these viruses to interindividual variations in immune responses.

The nucleic acid (and resulting protein) of these viruses usually resides and replicates in certain tissue (e.g., lymph/liver); spills into circulation; and then stimulates the immune system to produce antibodies. Thus, viral nucleic acid is present before antibodies appear, and differences in the Window Period between nucleic acid detection and serologic detection can be significant. The bar chart below depicts typical and longest-documented Window Periods for detection of HBC, HCV and HIV nucleic acid and antibodies:

SeraCare's HBV, HCV and HIV Donor Tissue Safety Testing Service

SeraCare employs our proprietary NAT method to detect the presence of HBV DNA, HCV RNA and HIV RNA using 100 mg quantities of tissue. The Limit of Detection (LOD) using our amplification technique is 1000 copies/ml of tissue homogenate, meaning"

• Reduced risk of exposure for you and your customers
• Increased confidence in the safety and quality of tissue used by your employees and customers

SeraCare BioServices brings unique, high-quality capabilities to this important testing:

• Scientists who have met our customers' needs for bacterial and viral testing since 1973
• Recognized experts in HBV, HCV and HIV NAT
• Quality-control of the majority of blood donations in the United States utilizes our NAT products
• FDA inspected, BSL-2 laboratory
• Operating under applicable CLIA certification and GLP and GMP conditions

References:

Belshe, et al; Ann Intern Med. 1194, 121(8) 584-9.
Busch, et al; Transfusion. 2000, 40:1157-1160.
Goodnough, et al; N Engl J Med. 1999, 340:438-447
Inagawa, et al; N Engl J Med. 1989, 320(22):1458-1462
Stramer, et al; Transfusion. 2000, 40:1165-1168
Zou, et al; N Engl J Med. 2004, 351:751-759
Stramer, et al; N Engl J Med. 2004, 351:760-768

It should be noted that, just as viral nucleic acid is present before antibodies appear, antibodies can be present when nucleic acid is not detectable, as a result of the host's immune response over time. Thus, a strategy for minimizing exposure would utilize both serologic (which almost certain to currently be performed on all donors) and Nucleic Acid Testing.