Efficacy of serologic marker screening in identifying hepatitis B virus infection in organ, tissue, and cell donors.
OBJECTIVE
Screens for serologic markers of hepatitis B virus (HBV) are used to prevent its transmission through transplantation. However, exclusion of noninfectious seropositive donors exacerbates graft shortages, and a residual risk of transmission by seronegative donors also exists. This study assessed the risk of HBV associated with different HBV serologic profiles in organ, tissue, and cell transplants, as well as the risk of HBV transmission from seronegative donors.


METHODS
A total of 11,155 consecutive organ, tissue, and cell donors were screened for HBV serologic markers. HBV DNA was screened for in 626 donors with at least one HBV serologic marker and 1433 multiple organ donors who were HBV seronegative or had anti-hepatitis B surface antigens (HBs) antibodies alone.


RESULTS
HBV DNA was detected in most HBs-antigen-positive donors, but HBV-DNA levels were considerably lower than in patients with chronic hepatitis B. HBV DNA also was found in organ and cornea donors without HBs antigen. The prevalence of HBV DNA in organ donors with no HBV serologic markers or isolated anti-HBs antibodies was 0.07% (95% confidence interval, 0.01%-0.40%). One HBV-DNA-positive organ donor with isolated anti-HBs antibodies had amino acid substitutions in the hepatitis B surface antigen sequence.


CONCLUSIONS
The analytic sensitivity of commercial hepatitis B surface antigen assays and their ability to detect HBsAg mutants should be improved. The utility and cost-efficacy ratio of systematic HBV-DNA testing should be assessed with the goal of excluding HBV-DNA-positive donations not identified through serologic testing while retaining donations that carry no risk of HBV transmission.
Challine
Dominique
D
Department of Virology, French National Reference Center for Viral Hepatitis B, C and Delta, Hôpital Henri Mondor, Université Paris 12, Créteil, France.
Chevaliez
Stéphane
S
Pawlotsky
Jean-Michel
JM
D000918:Antibody Specificity; D015415:Biomarkers; D001926:Brain Death; D004279:DNA, Viral; D006509:Hepatitis B / Q000175:diagnosis* / Q000453:epidemiology* / Q000517:prevention & control / Q000635:transmission; D006510:Hepatitis B Antibodies / Q000097:blood*; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D008403:Mass Screening / Q000592:standards* / Q000706:statistics & numerical data; D015995:Prevalence; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012307:Risk Factors; D012680:Sensitivity and Specificity; D016036:Seroepidemiologic Studies; D012699:Serology / Q000592:standards / Q000706:statistics & numerical data; D014019:Tissue Donors / Q000706:statistics & numerical data; D019737:Transplants / Q000592:standards* / Q000706:statistics & numerical data
D015415:Biomarkers; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic