New and Emerging Pathogens:
A Risk That Current Safety Measures Cannot Eliminate

Even as new tests are implemented to protect the blood supply, additional microbial threats continue to be recognized. As each new threat is identified, a new test must be developed, approved, manufactured, and implemented.

Identification of New Viral Threats to the Blood Supply
Over the Past Two Decades
Year Virus Associated Disease
1980 HTLV-1 Human T-cell Lymphotropic Virus-1 Malignant lymphoproliferative disorders, neuropathy [20, 21]
1982 HTLV-2 Human T-cell Lymphotropic Virus-2
1983 HIV-1 Human Immunodeficiency Virus-1 AIDS
1986 HIV-2 Human Immunodeficiency Virus-2
1986 HDV Hepatitis Delta Virus Coinfection or superinfection of HBV [22]
1989 HCV Hepatitis C Virus Viral hepatitis [23]
1990-91 HEV Hepatitis E Virus Clinically similar to HAV infection [24, 25]
1994-96 HHV-8 Human Herpes Virus-8 Kaposi's sarcoma [26]
1995-96 HGV Hepatitis G Virus (also called GBV-C) Clinical importance uncertain, but may have role in fulminant hepatitis [27]
1997 TTV New DNA virus named for patient Clinical importance uncertain [28]
1999 SEN-V New DNA virus No disease association [29]
2002 BDV Borna disease Neuropsychiatric disorders [30]
2002 WNV West Nile Virus Dengue-like illness; encephalitis in severe cases
2003 SARS* SARS virus (coronavirus variant) Severe Acute Respiratory Syndrome (atypical pneumonia)
 

* A potential new threat to the blood supply. SARS virus has been detected in the blood of patients with
SARS [31].

Known pathogens emerging in new geographical areas

West Nile Virus (WNV) provides a notable example of the ability of pathogens to migrate across continents and emerge as threats in new regions. Over the last 40 years, WNV has caused sporadic outbreaks of human disease in Europe. The most recent European outbreak in humans occurred in 1996-7 in Bucharest, Romania, and involved more than 500 recorded cases, with a fatality rate of ~10%. However, since 2002, a new strain of this virus has spread rapidly through the United States, with 12,375 cases of human WNV infection reported by February 18, 2003, and 466 associated deaths [32]. Furthermore, as of April 2003, it had been confirmed that 23 cases of WNV illness had developed in patients as a result of infection from a blood transfusion or organ transplant [33].
 
European distribution of WNV,
based on virus isolation
from mosquitoes or vertebrates [34]
Test

In pursuit of WNV.

Sporadic outbreaks of the virus have occurred throughout central and southern Europe over the last 40 years. Most recently, a prominant outbreak of the virus began in the United States in 1999. Confirmation that WNV could be transmitted through blood was reported in the fall of 2002, and the first blood screening test was made available under an Investigational New Drug (IND) later in the summer of 2003.

Benefits of the INTERCEPT Blood System

The benefits of the INTERCEPT Blood System are particularly attractive with respect to emerging pathogens, for which screening tests might not be immediately available. The unique mechanism of action of this pathogen inactivation system offers the potential to inactivate emerging pathogens before they become a major transfusion risk for patients.

Read our Technical Data Sheets for a list of CE Mark approved product claims.