Impact of nucleic acid testing for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus on the safety of blood supply in Italy: a 6-year survey.
ABSTRACT Nucleic acid testing (NAT) for hepatitis C virus (HCV) and human immunodeficiency virus (HIV) has been implemented in several European countries and in the United States, while hepatitis B virus (HBV) NAT is still being questioned by opinions both in favor and against such an option, depending on the HBV endemicity, health care resources, and expected benefits.
This survey was aimed to assess the NAT impact in improving the safety of blood supply in Italy, 6 years after implementation. The study involved 93 Italian transfusion centers and was carried out in 2001 through 2006. A total of 10,776,288 units were tested for the presence of HCV RNA, 7,932,430 for HIV RNA, and 3,405,497 for HBV DNA, respectively.
Twenty-seven donations or 2.5 per million tested were HCV RNA-positive/anti-HCV-negative; 14 or 1.8 per million units tested were HIV RNA-positive/anti-HIV-negative; and 197 or 57.8 per million donations tested were HBV DNA-positive/hepatitis B surface antigen-negative. Of the latter, 8 (2.3/10(6)) were collected from donors in the window phase of infection and 189 (55.5/10(6)) from donors with occult HBV. Sixty-eight percent of the latter donors had hepatitis B surface antibody, 74.5 percent of whom with concentrations considered protective (>or=10 mIU/mL).
NAT implementation has improved blood safety by reducing the risk of entering 2.5 HCV and 1.8 HIV infectious units per million donations into the blood supply. The yield of NAT in detecting infectious blood before transfusion was higher for HBV than for HCV or HIV. However, the benefit of HBV NAT in terms of avoided HBV-related morbidity and mortality in blood recipients needs to be further evaluated.
Article: Occult hepatitis B virus infection.[Show abstract] [Hide abstract]
ABSTRACT: Occult hepatitis B virus (HBV) infection (OBI) refers to the presence of HBV DNA in the absence of detectable hepatitis B surface antigen. Since OBI was first described in the late 1970s, there has been increasing interest in this topic. The prevalence of OBI varies according to the different endemicity of HBV infection, cohort characteristics, and sensitivity and specificity of the methods used for detection. Although the exact mechanism of OBI has not been proved, intra-hepatic persistence of viral covalently closed circular DNA under the host's strong immune suppression of HBV replication and gene expression seems to be a cause. OBI has important clinical significance in several conditions. First, OBI can be transmitted through transfusion, organ transplantation including orthotopic liver transplantation, or hemodialysis. Donor screening before blood transfusion, prophylaxis for high-risk organ transplantation recipients, and dialysis-specific infection-control programs should be considered to reduce the risk of transmission. Second, OBI may reactivate and cause acute hepatitis in immunocompromised patients or those receiving chemotherapy. Close HBV DNA monitoring and timely antiviral treatment can prevent HBV reactivation and consequent clinical deterioration. Third, OBI may contribute to the progression of hepatic fibrosis in patients with chronic liver disease including hepatitis C. Finally, OBI seems to be a risk factor for hepatocellular carcinoma by its direct proto-oncogenic effect and by indirectly causing persistent hepatic inflammation and fibrosis. However, this needs further investigation. We review published reports in the literature to gain an overview of the status of OBI and emphasize the clinical importance of OBI.World journal of hepatology. 12/2014; 6(12):860-9.
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ABSTRACT: Automated chemiluminescent immunoassays (CLIAs) are useful for the detection of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus 1/2 antigen/antibodies (HIV 1/2 Ag/Ab) in blood donor screening. Eight hundred and forty serum samples were tested for hepatitis B surface antigen (HBsAg), HCV antibodies (anti-HCV), and HIV1/2 Ag/Ab in parallel using 2 different CLIAs (Abbott Architect i2000SR and Roche Cobas e411). The concordance between the 2 systems was high (Cohen's kappa 0.97 for HBsAg, 0.77 for anti-HCV, 0.92 for HIV1/2 Ag/Ab) and the specificity and the positive predictive value were comparable. Among the 12 discrepant results, 11 were false-positive and 1 (reactive by Architect) was true-positive for anti-HCV. Positivity for HBV DNA, HCV RNA, and HIV RNA was recorded in 90.9%, 38.9%, and 100% of true-positive samples, respectively. This study represents the first stringent comparison between Architect i2000SR and Cobas e411 in blood donors. We observed a good correlation and high agreement among HBV, HCV, and HIV with the 2 automated systems.Scandinavian Journal of Infectious Diseases 07/2014; · 1.64 Impact Factor
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ABSTRACT: Safe blood transfusion where hepatitis is endemic In South-East Asia the prevalence of hepatitis B and C virus infections is high. Accurate – yet low-cost – screening of blood donors is crucial to avoid transfusion-transmitted disease. On (DATE) Le Viet will defend his thesis “Safe Blood Transfusion: Screening for Hepatitis B and Hepatitis C Virus Infections in Potential Blood Donors in Rural Southeast Asia” for the PhD degree at the Faculty of Health Sciences at UiT. The first aim of the thesis is to identify the accuracy of rapid tests for detection of acute hepatitis B, occult hepatitis B, and hepatitis C virus infections in potential blood donor in rural Vietnam and Cambodia. The second aim is to estimate prevalence of these infections among potential rural blood donors in Vietnam, and to examine the accuracy of enzyme immunoassay (EIA) technique in blood donor screening. The final goal is to estimate the risk of transfusion-transmitted hepatitis B in Vietnamese blood donors based on the available prevalence data and estimated prevalence of occult hepatitis B infection. 2,400 blood samples from potential voluntary rural blood donors in a multicentre cross-sectional study in Cambodia and Vietnam were analysed with rapid and EIA tests for detection of HBsAg, anti-HBc and anti-HCV at local laboratories. 640 randomly selected blood samples were blindly validated in a Norwegian accredited micro-laboratory by a chemiluminescent micro particle immunoassay technique (CMIA). Rapid test for donor screening of hepatitis proved to have far lover accuracy than claimed by the manufacturer; especially the false-negative rate was unacceptably high. The study revealed that hepatitis B infection is endemic in rural Vietnam and almost half of Vietnamese population is or has been infected with hepatitis B while hepatitis C infection is rare. The results indicate that the EIA performance in blood donor screening in Vietnam may be sub-optimal. The major risk factors for post- transfusion are HBsAg false-negative results and potential occult hepatitis B infections. Increased test sensitivity and locally validated HBsAg assays are recommended.11/2014, Degree: Philosophy Doctor (PhD), Supervisor: Hans Husums, Anne Husebekk, Eystein Skjerve