[Assessment of 32 months of continuous control of detection kits for anti-HIV and anti-HTLV antibodies and Hbs antigen used most commonly in transfusion biology. Retrovirus Study Group and Viral Hepatitis Study Group]
التفاصيل البيبلوغرافية
العنوان:
[Assessment of 32 months of continuous control of detection kits for anti-HIV and anti-HTLV antibodies and Hbs antigen used most commonly in transfusion biology. Retrovirus Study Group and Viral Hepatitis Study Group]
Controls were performed using a common internal panel specific for anti-HIV, anti-HTLV and HBs Ag. During the past 32 months, 5 anti-HIV1 + 2 antibody kits (Abbott, Behring, Biotest, Murex D. and Organon T., total of 199 lots), 4 anti-HTLV I/II antibody kits (Abbott, Murex D., Organon T. and Ortho C.D., total of 153 lots) and 5 HBs Ag kits (Abbott, S.D. Pasteur, Murex D., Organon T. and Ortho C.D., total of 244 lots) were used and controlled by the 14 participating laboratories. Analysis of the results showed the values obtained for the most representative sample of each panel to be within the limits m +/- 2 SD in 95 to 100% of the HIV1 + 2 kits, in 94 to 97% of the HTLV kits and in 92 to 100% of the HBs Ag kits. The specificity of the kits evaluated was on an average equal or superior to 99.5%, as required by the French Drug Agency in a blood donor population.