Superiority of minipool nucleic acid amplification technology for hepatitis B virus over chemiluminescence immunoassay for hepatitis B surface antigen screening.
OBJECTIVE
The Japanese Red Cross (JRC) have developed a fully automated multiplex (MPX) nucleic acid amplification technology (NAT) system for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus 1 (HIV-1). This is used to test serologically negative blood units from volunteer, non-remunerated donors. The system utilizes a 50-sample pool for NAT screening with an input volume of each pool. This results in a significantly higher sensitivity for hepatitis B than that seen with highly sensitive hepatitis B surface antigen (HBsAg) testing.


METHODS
From 1 February 2000 to 15 October 2001, over 11 million donations, which were serologically negative, were tested using the MPX NAT system. Donations found to be HBV DNA positive were further tested by using the chemiluminescence immunoassay (CLIA).


RESULTS
Out of 181 HBV DNA-positive donations, 96 (53%) and 76 (42%) were negative by individual enzyme immunoassay (EIA) and CLIA testing, respectively.


CONCLUSIONS
The sensitivity of the 50-sample pool MPX NAT system was higher than that of individual HBsAg screening by CLIA. By adopting this NAT-screening system, the JRC has improved the safety of the blood supply and maintained supply across Japan.
Minegishi
K
K
Japanese Red Cross Headquarter, Blood Services Department, Tokyo, Japan.
Yoshikawa
A
A
Kishimoto
S
S
Yugi
H
H
Yokoya
N
N
Sakurada
M
M
Kiyokawa
H
H
Nishioka
K
K
D001782:Blood Donors; D004279:DNA, Viral / Q000097:blood; D005188:False Negative Reactions; D006509:Hepatitis B / Q000175:diagnosis*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000592:standards*; D008163:Luminescent Measurements; D008403:Mass Screening / Q000379:methods / Q000592:standards; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D012680:Sensitivity and Specificity
D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens