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摘要
ObjectivesAim of the study was to evaluate performance of a new fully automated platform, DiaSorin-LIAISON (R) XL (DiaSorin S.p.A, Vercelli, Italy), in blood donor screening, specifically for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (anti-HBc), hepatitis C antibodies (anti-HCV), HIV p24 antigen, HIV antibodies, human T-lymphotropic virus types 1 and 2 (HTLV-1/2) and Treponema pallidum antibodies. BackgroundIn screening for such viral and bacteriological blood-borne infections, sensitivity and specificity are of utmost importance. MethodsSensitivity was evaluated using selected panels of samples previously analysed on the Abbott Architect immunoanalyser (Abbott Laboratories, Abbott Park, IL, USA)-the gold standard for this evaluation. These samples were confirmed positive for HBsAg, anti-HBc, anti-HCV, HIV Ag/Ab, anti-HTLV-1/2 and antibodies to T. pallidum, respectively. Specificity analysis was assessed by analysing blood donor samples previously run on the Architect platform and found non-reactive for each marker. A total of 1100 donor samples (both new and regular donors) were tested. Previously, non-specific reactive samples were also run for every tested marker, as well as samples with autoimmune antibodies and antibodies to other infections. ResultsThree hundred seventy-eight samples positive for the tested markers (HBsAgn=51, anti-HBcn=52, anti-HCVn=75, anti-Treponema n=55, anti-HIV-1 n=79, anti-HIV-2 n=25, anti-HIV 1/2 n=3, anti-HTLV-1 n=28 anti-HTLV-2 n=10) were tested and found positive, suggesting a high sensitivity. A number of 342-1100 negative blood donors (depending on marker) have been tested, with very good specificity for the markers tested, ranging between 995 and 100%, respectively. ConclusionsThe LIAISON (R) XL platform demonstrated very high sensitivity for the markers tested and the specificity necessary to fulfil the stringent requirements for blood donor screening.
- 出版日期2015-4
