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Mini-pool screening by nucleic acid testing for hepatitis B virus, hepatitis C virus, and HIV: preliminary results
M S Cardoso1, K Koerner, B Kubanek
1German Red Cross Blood Transfusion Service of Baden-Württemberg, Germany.
Background:
The purpose of this study was to evaluate the feasibility of nucleic acid testing (NAT) of mini-pools as a blood donation screening test.
Study Design And Methods:
The stepwise implementation of NAT of mini-pools began in January 1997. Since March 1997, all blood donations collected by the German Red Cross Blood Transfusion Service of Baden-Württemberg were tested for hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV nucleic acids. An extra barcoded serum sample is collected from each blood donor for NAT-based screening, which is performed only on hepatitis B surface antigen-, anti-HCV-, anti-HIV-, and anti-Treponema pallidum-seronegative donations. Samples are pooled to a maximum of 96. Positive results are resolved through intersecting subpools (a chessboard design). NAT-based screening does not include a virus concentration step before nucleic acid extraction.
Results:
By the end of October 1997, 331, 783 donations in 3,779 pools had been screened. As yet, no viremic but seronegative blood donor has been found for the three markers.
Conclusion:
It is feasible to incorporate NAT-based screening of mini-pools into the routine virus diagnostics of a large blood transfusion service. It remains to be determined whether screening blood donations by NAT will indeed increase the safety of blood supply.
