Posted February 8, 2011
Stramer S. N Engl J Med. 2011;364:236-247.
A triplex nucleic acid assay detected potentially infectious hepatitis B virus, hepatitis C virus and HIV after analyzing the serologic, biochemical and molecular features of 3.7 million blood donations, according to study findings.
All blood donations in the US have been screened for hepatitis B surface antigen, but the researchers said a small proportion of donors with antibodies against hepatitis B core antigen in the absence of hepatitis B surface antigen have circulating hepatitis B virus (HBV) DNA and may have a risk of infectivity. Additionally, blood collected during the early window period of HBV infection is highly infectious, but the risk decreases as hepatitis B develops.
In 2008, 2,137,275 donors made a total of 3,694,858 donations. Using the Ultrio assay (Gen-Probe), researchers discovered 26 confirmed infections (nine HBV, 15 hepatitis C virus [HCV] and two HIV), giving the assay a positive predictive value of 35%.
The nine patients with HBV had seronegative HBV DNA-positive samples, and all but one was detected on mini-pool nucleic acid testing. Researchers had expected to find no more than four seronegative HBV DNA-positive samples.
Six infected donors had been vaccinated for HBV. Researchers said routine screening for hepatitis B surface antigen or antibodies against hepatitis B core antigen would not have uncovered those infections.
They said the infections were of “inconsequential clinical significance, but their potential for transmission remains unresolved.”
“Our findings show the efficacy of the HBV vaccine for the prevention of clinical disease but not infection, and the cost of interdicting donations that contain HBV DNA from seronegative donors is high in the face of unknown benefit,” they wrote.
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