[Evaluation of the analytic performance of blood collection tubes (BD Vacutainer SST) for the screening of anti-HIV, anti-HTLV, anti-HCV, anti-HBc, anti-CMV antibodies, and of HBs, P24 HIV antigens, and of alanine aminotransferase].
The Laboratory of Viral Diseases Immunology (Laboratoire d'Immunologie des Maladies Virales) of the Northern Region Blood Bank (Etablissement Français du Sang Nord de France) performs between 180.000 and 200.000 viral blood qualifications per year. The use of a serum gel separator evacuated tube should contribute to improve the quality of the pre-analytical phase. However, it must not impact negatively the analytical performances. We evaluated such tube within our specific environment and with the various reagents used in routine. The open study compared the BD Vacutainer plain tube (7 mL, non siliconised) with the BD Vacutainer SST 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 alanine aminotransferase. The study objectives were to find potential gel interference; to verify the diagnostic sensitivity, reagents specificity, and reproducibility. The results analysis show: equivalent performances with the anti-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; lower performances with: The Vironostika HIV Uni Form II plus 0--Organon kit with a -3.5% signal decrease around the ratio R = 2.7 for positive anti-HIV Ab. The Elisa test System 3 Ag HBs-Ortho kit with an increase of the mean ratio of the negative Ag HBs samples; better performances with: the Vironostika HIV 1 Antigen--Organon kit with a +10% signal increase around the threshold ratio R = 1 for positive Ag HIV samples. This deserves further study to verify that the specificity is maintained. The HTLV Type 1 et 2 EIA--Ortho kit with +8% signal increase around the ratio R = 2 for positive anti-HTLV Ab samples without change of the specificity. The Ortho HCV 3.0 Elisa Test System and HTLV Type 1 et 2 EIA kits with a clear and significant improvement of the reproducibility of the anti-HCV and anti-HTLV Ab screenings. The results of this evaluation, together with the intrinsic BD SST 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, as with any other material or reagent, request a close monitoring of the first results to confirm the absence of negative effects.
Gobin
E
E
Secteur développement expertise qualité, laboratoire d'immunologie virale, Etablissement français du sang-Nord de-France, 21, rue Camille-Guérin, BP 2018, 59012 Lille, France.
Desruelle
J M
JM
Vigier
J P
JP
D000410:Alanine Transaminase / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood*; D001771:Blood Banks; D001782:Blood Donors; D001800:Blood Specimen Collection / Q000295:instrumentation* / Q000379:methods; D003587:Cytomegalovirus / Q000276:immunology; D015480:Deltaretrovirus Antibodies / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005602:France; D015483:HIV Antibodies / Q000097:blood*; D016655:HIV Core Protein p24 / Q000097:blood*; D006510:Hepatitis B Antibodies / Q000097:blood; D006511:Hepatitis B Antigens / Q000097:blood*; D018937:Hepatitis C Antibodies / Q000097:blood; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000914:Antibodies, Viral; D015480:Deltaretrovirus Antibodies; D015483:HIV Antibodies; D016655:HIV Core Protein p24; D006510:Hepatitis B Antibodies; D006511:Hepatitis B Antigens; D018937:Hepatitis C Antibodies; D007074:Immunoglobulin G; D000410:Alanine Transaminase