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Sensitivity of hepatitis B virus DNA transcription‐mediated amplification testing in hepatitis B surface antigen–positive blood donations
Author(s) -
Bouchardeau Françoise,
Girault Annie,
Razer Annie,
ServantDelmas Annabelle,
Mercier Mélanie,
Laperche Syria
Publication year - 2006
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2006.01031.x
Subject(s) - hbsag , nat , hbeag , hepatitis b virus , virology , medicine , hepatitis b , antigen , viral load , immunology , virus , computer science , computer network
BACKGROUND: The objective was to evaluate the performance of nucleic acid testing (NAT) in the detection of hepatitis B virus (HBV) infection in hepatitis B surface antigen (HBsAg)‐positive blood donations. STUDY DESIGN AND METHODS: A total of 253 HBsAg‐ and anti‐hepatitis B core antigen (HBc)‐positive samples (50 hepatitis B e antigen [HBeAg]‐positive and 203 anti‐HBe–positive) from blood donations collected in France were studied. The samples were investigated with a blood screening assay (Procleix Ultrio, Chiron/Gen‐Probe) in minipool (MP; ×8) and in individual‐donation (ID) testing. All nonreactive samples were retested once, and nonreactive MP samples were assayed for viral load (VL). RESULTS: All 50 HBeAg‐positive samples were reactive in MP‐NAT and ID‐NAT. Of the 203 anti‐HBe–positive donations, 80.3 percent were MP‐ and ID‐reactive, 17.2 percent were MP‐nonreactive and ID‐reactive, and 2.5 percent were nonreactive in ID‐NAT. Overall the sensitivity of ID‐NAT was 98 percent versus 84 percent for MP‐NAT. After retesting, 16 of the 35 MP‐nonreactive and/or ID‐reactive donations became MP‐reactive and 2 of the ID‐nonreactive donations became NAT‐reactive. The capacity of Procleix Ultrio to detect HBV DNA was not related to HBsAg subtype, but correlated with the VL: the mean VL in the group of MP‐nonreactive samples was 1,420 copies per mL vs. 17,000 copies per mL in the group of 40 MP‐reactive samples. CONCLUSION: These results demonstrate that HBV‐NAT in ID format is far more effective in detecting viremia in chronic HBsAg carriers than in MP‐NAT. The sensitivity of the NAT assay needs to be improved to be considered for replacing the current HBsAg assays, especially when anti‐HBc testing is not performed.