Evaluation of evacuated blood collection tubes (BD Vacutainer (TM) SST (TM)) analytical performances for the screening of anti-HIV, anti HTLV, anti-HCV, anti-HBc, anti-HBs, anti-CMV antibodies, and of HBs, P24HIV antigens and for the assay of alanine aminotransferase.

The Laboratory of Viral Diseases Immunology (Laboratoire d'Immunologie des Maladies Virales) of the Northern Region Blood Bank (Etablissement Francais du Sang Nord de France) performs between 180,000 and 200,000 viral blood q ualifications per year. The use of a serum gel separator evacuated tube sho uld contribute to improve the quality of the pre-analytical phase. However, it must not impact negatively the analytical performances. We evaluated su ch tube within our specific environment and with the various reagents used in routine. The open study compared the ED Vacutainer(TM) plain tube (7 mL, non siliconised) with the ED Vacutainer(TM) SST(TM) tube (6 mL siliconised with serum gel separator) against the anti-HIV, anti-HTLV, anti-HCV, anti- HBc, anti-HBs, anti-CMV antibodies, the HBs, HIV P24 antigen and the alanin e aminotransferase. The study objectives were to find potential gel interfe rence, to verify the diagnostic sensitivity, reagents specificity, and repr oducibility. The results analysis show : equivalent performances with the a nti-HIV Ab (Anti HIV 1/2 recombinant Biotest et Genscreen HIV 1/2 - Sanofi) , anti HIV WB Ab (New lav Blot 1 - Sanofi), anti-HBs Ab (Enzygnost anti-HBs micro - Behring), anti-HBc Ab (HBc Elisa Test System - Ortho), anti-CMV Ab (Enzygnost anti-CMV IgG + M - Behring) kits; tower performances with. The Vironostika HIV Uni Form II plus 0 - Organon kit with a - 3.5 % signal decr ease around the ratio R = 2.7 for positive anti-HIV Ab. The Elisa test Syst em 3 Ag HBs - Ortho kit with an increase of the mean ratio of the negative Ag HBs samples; better performances with: the Vironostika HIV I Antigen - O rganon kit with a + 1 0 % signal increase around the threshold ratio R = 1 for positive Ag HIV samples. This deserves further study to verify that the specifity is maintained. The HTLV Type 1 et 2 EIA - Ortho kit with + 8 % s ignal increase around the ratio R = 2 for positive anti-HTLV Ab samples wit hout change of the specificity. The Ortho HCV 3.0 Elisa Test System and HTL V Type 1 et 2 EIA kits with a clear and significant improvement of the repr oducibility of the anti-HCV and anti-HTLV Ab screenings. The results of thi s evaluation, together with the intrinsic ED SST(TM) tube characteristics, lead to the conclusion that its use would contribute to improve the quality . Because of the specificities of each laboratory, a change of tube type, a s with any other material or reagent, request a close monitoring of the fir st results to confirm the absence of negative effects. (C) 2001 Editions sc ientifiques et medicales Elsevier SAS.