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.
BACKGROUND
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Velati
Claudio
C
Department of Transfusion Medicine and Haematology, Hospital of Sondrio, Sondrio, Italy.
Romanò
Luisa
L
Fomiatti
Laura
L
Baruffi
Lorella
L
Zanetti
Alessandro Remo
AR
D000328:Adult; D000368:Aged; D001771:Blood Banks / Q000592:standards* / Q000706:statistics & numerical data*; D001782:Blood Donors; D005260:Female; D005838:Genotype; D006678:HIV / Q000235:genetics / Q000302:isolation & purification; D015658:HIV Infections / Q000097:blood / Q000453:epidemiology / Q000635:transmission; D019538:Health Care Surveys; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D006509:Hepatitis B / Q000097:blood / Q000453:epidemiology / Q000635:transmission; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D006526:Hepatitis C / Q000097:blood / Q000453:epidemiology / Q000635:transmission; D006801:Humans; D007558:Italy; D008297:Male; D008403:Mass Screening / Q000592:standards / Q000706:statistics & numerical data; D008875:Middle Aged; D009017:Morbidity; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012449:Safety; D016036:Seroepidemiologic Studies; D014777:Virus Diseases / Q000097:blood / Q000453:epidemiology / Q000635:transmission